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FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information
Eileen Zhou Research Associate Neuralstem Germantown, MD, United States [email protected]
Michael Channing Group Chief - Positron Emission Tomography Department NIH Bethesda, MD, United States [email protected]
A B M Mahfuz ul Alam General Manager, Quality Operations ACI HealthCare Limited Dhaka, Non-US, Bangladesh [email protected]
Abe Wong CCO Gmpsigma Seattle, WA, United States [email protected]
ABHIJEET GUJAR Chief Operating Officer SETHU Porvorim Goa, Non-US, India [email protected]
Adam Ebbinghouse QC Associate KP Pharmaceutical Technology, Inc. Bloomington, IN, United States [email protected]
Adil Gatrad Director, Quality Systems Actavis Parsippany, NJ, United States [email protected]
Adiseshu Modugula RA MSN Hyderabad, Non-US, India [email protected]
Aditiben Patel Regulatory Specialist USAMMDA Frederick, MD, United States [email protected]
Adriana de la Cruz Manager Laboratorios Pisa SA de CV Jalisco, Non-US, Mexico [email protected]
ahsanul haque CSO FDA silver spring, MD, United States [email protected]
Aimee Gogarty Quality Coordinator Mallinckrodt Port Allen, LA, United States [email protected]
Aislyn Fronzak QC Manager PL Developments Clinton, SC, United States [email protected]
Ajay Deshmukh QA manager Ingenus Pharmaceutical Navi mumbai, Non-US, India [email protected]
Ajay Khedkar Regulatory Affair Umedica Laboratories Pvt Ltd Mumbai, Non-US, India [email protected]
Ajay Pazhayattil Associate Director Apotex Toronto, Non-US, Canada [email protected]
Ajay Taluja Staff Fellow FDA Silver Spring, MD, United States [email protected]
ajit reddy Sales mettler toledo Hyderabad, Non-US, India [email protected]
akash babber Microbiologist sgco jubail, Non-US, Saudi Arabia [email protected]
ALAN N[CHOLLS Sr Advisor,Regulatory Affairs COPPERHEAD CHEMICAL COMPANY INC TAMAQUA, PA, United States [email protected]
Albinus D'Sa Special Assistance to the Office FDA Silver Spring, MD, United States [email protected]
Alejandra Gómez Project Leader Laboratorios PiSA Guadalajara, Non-US, Mexico [email protected]
Alice Hoffmann Head of Quality Assurance GMP Eurofins BioPharma Product Testing Munich GmbH Planegg/Munich, Non-US, Germany [email protected]
Alicia Fitzpatrick EHS Regulatory Manager The Dow Chemical Company Bristol, PA, United States [email protected]
Allen Che senior scientist Tetraphase Pharmaceuticals Watertown, MA, United States [email protected]
Allison Aldridge Team Leader FDA Silver Spring, MD, United States [email protected]
allison bonnenburg Regulatory Counsel FDA Silver Spring, MD, United States [email protected]
Allison Murdza Process Development Intern Merck Lexington, MA, United States [email protected]
Alvin Negron Technical Consultant DGF Group San Juan, Non-US, Puerto Rico [email protected]
Amanda Rennig Senior QA/QC Associate Digestive Care, Inc Easton, PA, United States [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information
Amar Edlaher Chief Compliance Officer American Pharmaceutical Ingredients, LLC Boca Raton, FL, United States [email protected]
Ambrose Stafford Founder Stafford Pharma Consulting, LLC Hillsborough, NJ, United States [email protected]
Amidhepuram Sudheer Sr. Manager Hetero drugs Hyderabad, Non-US, India [email protected]
Amit Dumpawar Senior Executive Wockhardt Limited India Aurangabad, Non-US, India [email protected]
Amy Blevins Quality & Regulatory Specialist Kenco Logistic Services, LLC Chattanooga, TN, United States [email protected]
Amy Ganden QA & Methods Compliance, Manager Particle Technology Labs Downers Grove, IL, United States [email protected]
Amy Haataja Quality Assurance Supervisor Perrigo New Hope, MN, United States [email protected]
Ana Padilla Technician Inke, S.A. Castellbisbal, Non-US, Spain [email protected]
Anais Valencia Laboratory MAnager Henry Jackson Foundation/MHRP Silver Spring, MD, United States [email protected]
Andra Bene Site Quality Engineer Celestica Romania SRL Oradea, Non-US, Romania [email protected]
Andres Rivas Engineering and Projects Director Laboratorios PiSA SA de CV Guadalajara, Non-US, Mexico [email protected]
Andrew Asirvatham Quality Assurance caplin point laboratories Chennai, Non-US, India [email protected]
Andrew Hooper Director Commercial Manufacturing Retrophin, Inc. San Diego, CA, United States [email protected]
Anees Moosa Retail pharmacist Private Johannesburg, Non-US, South Africa [email protected]
anelis aurand araos Director, Scientific Affairs WellSpring Pharmaceutical Corporation Sarasota, FL, United States [email protected]
Angela Hughes QC Manager SPI Pharma Lewes, DE, United States [email protected]
Angelica Rivas Quality Director MediStem Panama Inc Panama, Non-US, Panama [email protected]
Angella Silye Study Manager Taro Pharmaceuticals USA Hawthorne, NY, United States [email protected]
Anirudh Ramachandran Consultant Ernst & Young,LLP Mumbai, Non-US, India [email protected]
Ann Howard Reg Assoc igi labs Buena, NJ, United States [email protected]
Anna Long Attorney Dean, Mead, Egerton, Bloodworth, Capouano &Bozarth, P.A. Orlando, FL, United States [email protected] Anne Armstrong
QA & Compliance Mgr Drug Store, Pets and Consumables Meijer, Inc. Grand Rapids, MI, United States [email protected]
Anne Kuan VP Reg Neovii Waltham, MA, United States [email protected]
Annette Dunn CEO Coda Corp USA Fairport, NY, United States [email protected]
Annia Diggs QAQC Specialist Johns Hopkins Univ. SOM / CPGT Baltimore, MD, United States [email protected]
Anshuman Saran Head CQA Strides Arcolab Limited Bangalore, Non-US, India [email protected]
Antonio Soto Handy Solutions Business Director Navajo Manufacturing Co. Inc. Denver, CO, United States [email protected]
Anuj Patel Quality assurance Intas pharmaceutical limited Ahmedabad, Non-US, India [email protected]
Anush Perikhanyan QA Manager DarmanTest Laboratories Yerevan, Non-US, Armenia [email protected]
April Griggs Compliance Management Unit Director WRAIR, Viral Diseases Branch Silver Spring, MD, United States [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information
Archana Shekher Consultant Consultant Morrisville, NC, United States [email protected]
Arenia Chavez assistant chemical chemist Astecal Sac Lima, PA, Peru [email protected]
Arianne Bouchard-Gagnon QA associate Nuvo Research Varennes, Non-US, Canada [email protected]
Arshad Ali Incharge Compliance Cell Zafa Pharmaceutical Laboratories (Pvt.) Ltd KARACHI, Non-US, Pakistan [email protected]
Arthur Fabian President Fabian API Consulting LLC Parsippany, NJ, United States [email protected]
Artur Shchukin RC Specialist AMPAK New York, NY, United States [email protected]
ARUN THANGAVELU OPERATIONS ENGINEERING SPECIALIST CELESTICA TORONTO, Non-US, Canada [email protected]
Arvind Bhalerao Director-Operations Orit Laboratories LLC West Caldwell, NJ, United States [email protected]
Asheley Pankratz Senior Paralegal American Pharmaceutical Ingredients, LLC Boca Raton, FL, United States [email protected]
Ashlee Janusziewicz Consumer Safety Officer FDA Silver Spring, MD, United States [email protected]
Ashley Boam Director (A), Ofc of Policy for Pharmaceutical Quality FDA/CDER Silver Spring, MD, United States [email protected]
Ashok Kumar Boyapati Officer Raks pharma Pvt Limited Visakhapatnam, Non-US, India [email protected]
Asma Ather Documentation Specialist Xttrium Laboratories Mount Prospect, IL, United States [email protected]
Atul Sakariya Corporate Quality Sun Pharmaceutical Industries Limited Vadodara, Non-US, India [email protected]
Audrey Zaweski President Peconic Regulatory Consulting LLC Calverton, NY, United States [email protected] Aurelis Cosme
Chemist- Quality Control Gasco Industrial Gurabo, Non-US, Puerto Rico [email protected]
Avia Toney Vice President of Quality Assurance and Regulatory Affairs GeNO LLC Cocoa, FL, United States [email protected]
B R Reddy Director-Operations Natco Pharma Ltd Hyderabad, Non-US, India [email protected]
Baban Bhalerao Sr. Officer EnEm Nostrum Remedies Pvt. Ltd. Mumbai, Non-US, India [email protected]
Babu Lad Dir. Regulatory Affairs Pharmaceuticals Parsippany, NJ, United States [email protected]
Bahrudin Kapo QAS Supervisor Belcher Pharmaceutical Largo, FL, United States [email protected]
bala kumar Associate - Regulatory Affairs Shasun Pharmaceuticals Limited Puducherry, Non-US, India [email protected]
Bala Nagisetti QA-Manager Sciegen Pharmaceuticals Inc Hauppauge, NY, United States [email protected]
balakrishna Nunna Dy. Manager -RA Bioplus lifesciences pvt limited bangalore, KS, India [email protected]
Bangon Longsomboon Regulatory Manager University of Miami, Miller School of Medicine Miami, FL, United States [email protected]
Barbara Hach QA Manager Cosmax USA Solon, MA, United States [email protected]
Barbara Thorne Executive Director Pr Dev. Celladon Seattle, WA, United States [email protected]
Barry Goodwin COO ONY, Inc. Amherst, NY, United States [email protected]
Becky Nortz Associate Director, Regulatory Affairs New Haven Pharmaceuticals North Haven, CT, United States [email protected]
Ben LU VP, Quality Sagent China Pharmaceuticals Chengdu, Non-US, China [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information
Benjamin Cordova Chemist Thibiant Internationl Chatsworth, CA, United States [email protected]
Benjamin Do Regulatory Affairs Coordinator Diamond Wipes International Chino, CA, United States [email protected]
Benjamin Kraus Auditor for Medical Devices Strauss Medizintechnik Bochum, Non-US, Germany [email protected]
Benjamin Stevens Chemistry Reviewer FDA White Oak, MD, United States [email protected]
Bernadette De Leye Quality Excellence Coach STEXCON Haasrode, Non-US, Belgium [email protected]
Beth Carr Pharmacist FDA/CDER Silver Spring, MD, United States [email protected]
Betty Jo Lorenz VP, Quality & Regulatory Bell Pharmaceuticals, Inc. Belle Plaine, MN, United States [email protected]
BETTY LLANA Inspector GMP MINISTRY OF HEALTH DIGEMID PERU LIMA, Non-US, Peru [email protected]
Beverly Folmer Manager, Pharmaceutical Development Incyte Germantown, MD, United States [email protected]
Bhagwan Chaudahry Research Analyst Sunidhi Securities Mumbai, Non-US, India [email protected]
Bhagyashree Bhargave Senior Group Leader Strides Arcolab Limited Bangalore, Non-US, India [email protected]
Bhim Bahadur Chaudhari Research UIPS,Panjab University chandigarh, Non-US, India [email protected]
bipin kumar Audit and Compliance wockhardt Aurangabad, Non-US, India [email protected]
bipin kumar Audit and Compliance wockhardt Aurangabad, Non-US, India [email protected]
Blanca Zabala Pharmacy staff N/A Miami, FL, United States [email protected]
Bob MacDonald Vice President, Regulatory Affairs Scientific & Regulatory Consultants, Inc. Columbia City, IN, United States [email protected]
Bobae Kim VP Quality, Regulatory, Clinical Affairs Iluminage Beauty Inc. New York, NY, Canada [email protected]
Brandi Adoff Director Regulatory Affairs Vensun Yardley, PA, United States [email protected]
Brian Mabie Pharmacist-in-Charge American Pharmaceutical Ingredients, LLC Waterford, MI, United States [email protected]
Brian Newton Head of Risk & Regulatory Affairs PROTein Biotechnologies Inc Ramona, CA, United States [email protected]
Brittany Ann Medeo Compliance Consultant QACV Consulting Bethlehem, PA, United States [email protected]
Brooke Yakatan Director, QA & Regulatory IriSys LLC San Diego, CA, United States [email protected]
Caprice Bearden Director of Compliance Pharmakon Pharmaceuticals Noblesville, IN, United States [email protected]
Caption Colorado Captioner Caption Colorado Greenwood Village, CO, United States [email protected]
Carla Silva RA analyst Aché Laboratórios Farmacêuticos Guarulhos, Non-US, Brazil [email protected]
Carlos Amaro Technical Director Inmed Per{u S.A.C. Lima, Non-US, Peru [email protected]
Carlos Martin Mayma A. Regulatory assesor DIGEMID LIMA, Non-US, Peru [email protected]
Carlos Montoyo Senior Consultant DGF Group San Juan, Non-US, Puerto Rico [email protected]
Carlton Rhames QA Supervisor Capstone Nutrition Spring Hill, TN, United States [email protected]
Carmen Kelly Consumer Safety Officer FDA Silver Spring, MD, United States [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information
Carmen Janneth Rivera Palacin Químico Farmaceutico Drección General de Medicamentos, Insumos y Drogas DIGEMID Lima, Non-US, Peru [email protected]
Carol Marchione VP, Reg Affairs and QA TetraLogic Pharmaceuticals Malvern, PA, United States [email protected]
Carolina Geraldo Assessor Farmacêutico Aché Laboratórios Farmacêuticos S.A. São Paulo, Non-US, Brazil [email protected]
Catherine Johnson HLS Regulatory Lead WIpro Highland Park, IL, United States [email protected]
Catherine Mastrorilli Assistant Scientist Janssen R&D Malvern, PA, United States [email protected]
Catrina Montgomery GCP Coordinator Romark Labortories Tampa, FL, United States [email protected]
Celeste Goddard Regulatory Affairs Specialist Merz North America Raleigh, NC, United States [email protected]
Celia Hernandez Manager Laboratorios Pisa SA de CV Jalisco, Non-US, Mexico [email protected]
Cesar Burgos QC Tech SHL Pharma Boca Raton, FL, United States [email protected]
Chakrapani Kambhampati MANAGER MYLAN VISAKHAPATNAM, Non-US, India [email protected]
chander kazipeta Head - Global Regulatory Affairs airis PHARMA Hyderabad, Non-US, India [email protected]
CHANDRA SHEKAR GUMPALLY Assistant Manager Dr.Reddys Laboratories Limited Hyderabad, Non-US, India [email protected]
chandrasahker akula Manager Validation AMRI Albany, NY, United States [email protected]
Chang Lee Sr. Dir, RA/CA Capsugel Morristown, NJ, United States [email protected]
changguang wang scientist UTSW DALLAS, TX, United States [email protected]
Chantal Joly quality specialist (consultant) Telesta Therapeutics Inc. Pointe-Claire, Non-US, Canada [email protected]
Chantal Pare QA Manager Nuvo Research Inc. Varennes, Non-US, Canada [email protected]
Charan Behl Manager PAC Pharmaceuticals, LLC Far Rockaway, NY, United States [email protected]
Charles Celeste Director, Regulatory Pollicy & Intell Leo Pharma Parsippany, NJ, United States [email protected]
Charles DiTusa Quality Assurance USAMMDA Ft. Detrick, MD, United States [email protected]
Chaudhry Tajammal Hussain Quality Systems and Standards Lead Novartis Pharma Karachi, Non-US, Pakistan [email protected]
Chee Kean Ong Senior QRA Manager Celestica Malaysia Sdn. Bhd. Kulim, Non-US, Malaysia [email protected]
Chelsea Cabral chemist Queen's Medical Center Honolulu, HI, United States [email protected]
Chethan Jungir research and development Biocon research labs Bangalore, Non-US, India [email protected]
Chi Vo R&D Manager Nuvo Research Inc. Varennes, Non-US, Canada [email protected]
chong kim CMC Reviewer OLDP/OPQ/CDER Silver Spring, MD, United States [email protected]
Chris Fowler Member Chris Fowler, LLC Newtown, CT, United States [email protected]
Chris Goodpaster Quality Control Microbiologist ISTO Technologies Ollivette, MO, United States [email protected]
Chris Holshouser Owner GH Quality Consulting Wilmington, NC, United States [email protected]
Chris Jacques Sr. Manager Corium International, Inc. Grand Rapids, MI, United States [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information
Chris Wubbolt President & CEO QACV Consulting, LLC Bethlehem, PA, United States [email protected]
Christina Thompson QA Alvix Laboratories Ocean Springs, MS, United States [email protected]
Christine Hendricks Quality Assurance Group Leader Consumer Product Testing Company Fairfield, NJ, United States [email protected]
Christine Miller VP Regulatory Affairs TherapeuticsMD Boca Raton, FL, United States [email protected]
Christopher Smith President Coastal Pharmaceutical Consultants, Inc. Burgaw, NC, United States [email protected]
Chunli Zhao QA Director Asychem Lab. Tianjin, Non-US, China [email protected]
Cici Lu RA Yaopharma Co., Ltd. Chongqing, Non-US, China [email protected]
Cindy Lumbert Quality Compliance Manager Lakeshore Technologies Norton Shores, MI, United States [email protected]
Cindy Martin Director, Regulatory Affairs Aerie Pharmaceuticals, Inc. Irvine, CA, United States [email protected]
Cinzia Romero Pharmacist MINSA PERU Lima, Non-US, Peru [email protected]
Claire German Project Coordinator FDA Rockville, MD, United States [email protected]
Colleen Johns Regulatory Affairs Sancilio and Company Riviera Beach, FL, United States [email protected]
congbiao mei senior group leader united therapeutics silver spring, MD, United States [email protected]
CONSUELO LI PHARMACIST EVALUATOR DIGEMID lima, Non-US, Peru [email protected]
Corrine Knight Director of Business Initiatives Coda Corp USA Fairport, NY, United States [email protected]
Creighton Tuzon Research Associate USC Los Angeles, CA, United States [email protected]
Cris Lebrilla Director of Quality Assurance C3 Jian, Inc. Marina del Rey, CA, United States [email protected]
Crystal Gabriel Sr Process Tech SHL-Group Deerfield Beach, FL, United States [email protected]
Dale Allen Associate Director Dynport Vaccine Company, CSC-GS Frederick, MD, United States [email protected]
Dan Bigman VP of Quality Gasco Industrial Gurabo, Non-US, Puerto Rico [email protected]
Dan Wunderlich Director QA/RA WellSpring Pharmaceutical Canada Oakville, Non-US, Canada [email protected]
Daneris Fernandez CEO DGF Group San Juan, Non-US, Puerto Rico [email protected]
Daniel Gastelu President Health Product Business Success LLC Sparta, NJ, United States [email protected]
Daniel Kashiwagi Researcher Prati-Donaduzzi Toledo, Non-US, Brazil [email protected]
Darrin Hofer Compliance Manager Conair Corporation Rantoul, IL, United States [email protected]
DARSHAN THAKKAR REGULATORY OFFICER sTEPUP PHARAMATECH AHMEDABAD, Non-US, India [email protected]
datta tupepatil manager UMEDICA LABORATORIES PVT LTD mumbai, IN, India [email protected]
David Hernandez Director, Regulatory Affairs Chemo Group Chatham, NJ, United States [email protected]
David Jara QA Associate Xttrium Labs Mt. Prospect, IL, United States [email protected]
David Beristain Manager Proquina/Bayer Orizaba, Non-US, Mexico [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information
David Ferch Operations Manager Valjean Corporation Indian Harbour Beach, FL, United States [email protected]
David Kuchta QA Mgr. QuadPharma LLC Clarence, NY, United States [email protected]
David Lin Senior Consultant Biologics Consulting Group Potomac, MD, United States [email protected]
david mcfarland editor fda webview camp hill, PA, United States [email protected]
David Meredith Quality Supervisor Kenco Logistics Chattanooga, TN, United States [email protected]
David Pereira Director of Operations Afton Scientific / AnovaFill Charlottesville, VA, United States [email protected]
David Swain Vice President, Regulatory Affairs Scientific & Regulatory Consultants, Inc. Columbia City, IN, United States [email protected]
david zhao Sr. VP Prinbury Biopharm Pudong, Non-US, China [email protected]
Davina Marano Regulatory Counsel FDA/CDER/OC Silver Spring, MD, United States [email protected]
dawn spooner regulatory affairs perkinelmer waltham, MA, United States [email protected]
Deana Kaye President and Principal Medical Writer II DBL Clinical Associates, Inc. Durham, NC, United States [email protected]
Debaleena Bandopadhyay Regulatory Associate Astex Pharmaceuticals Pleasanton, CA, United States [email protected]
Debashis Chakraborty Manager-QA Raks Pharma Pvt.Ltd. Visakhapatnam, Non-US, India [email protected]
Debashish Panda Head Quality Naprod Life Sciences Mumbai, Non-US, India [email protected]
Debbie Gumpert Regulatory Specialist II Albemarle Corporation South, MI, United States [email protected]
debolina sen roy student pes college of pharmacy bengaluru, Non-US, India [email protected]
Deborah Formelio Clinical Quality Manager Romark Laboratories, L.C. Tampa, FL, United States [email protected]
Debra Dow President Dow Development Laboratories, LLC Petaluma, CA, United States [email protected]
Debra Lehnus QA/Regulatory Manager Prestige Packaging Fort Myers, FL, United States [email protected]
Delaram Moshkelani Review Chemist FDA Silver Spring, MD, United States [email protected]
Delphine MERCIER Quality team member MEDINCELL Jacou, Non-US, France [email protected]
Denis Seungryum Kim Intellectual Property Associate Celltrion Pharm Cheong Ju, Non-US, South Korea [email protected]
Denise Ekstrom RA Manager DVC Frederick, MD, United States [email protected]
Dequan Zhu Operation Director Shuang Bei Medical Group Tianjin, Non-US, China [email protected]
DERAJRAM BENIVAL Manager (Corporate R & D) HLL Lifecare Limited Trivendrum, Non-US, India [email protected]
Derry Spragion Scientist Catalent Pharma Solutions Morrisville, NC, United States [email protected]
devender Malhotra Sr.Executive Solrex Pharmaceuticals Company baddi, Non-US, India [email protected] Devendra Chavan
Senior Research Scientist Colgate Palmolive India Limited Mumbai, Non-US, India [email protected]
DHARMESH PATEL Head Regulatory Affairs Atul Limited Valsad, Non-US, India [email protected]
Dhiren Bhatt Deputy General Manager Wockhardt Ltd. Aurangabad, Non-US, India [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information
Diallo Mamadou President Diallo Global CMC Attleboro, MA, United States [email protected]
Diana Baronian Sr. Quality Specialist Guthy|Renker LLC Santa Monica, CA, United States [email protected]
Diana Lozano QA Compliance Gilead Sciences, Inc. San Dimas, CA, United States [email protected]
Diana Parra Student Student Pittsburgh, PA, United States [email protected]
Dilip Parikh President DPHARMA GROUP INC. ELLICOTT CITY, MD, United States [email protected]
Dimple Bommanaboina Regulatory Affairs Citron Pharma LLC East Brunswick, NJ, United States [email protected]
Dinesh Kumar Regulatory Counsel FDA Silver Spring, MD, United States [email protected]
Dipa Ramolia Sr. Manager, Quality LEO Pharma Inc. Parssippany, NJ, United States [email protected]
Dipenkumar Patel Senior Associate, Regulatory Affairs Granules USA, Inc. Parsippany, NJ, United States [email protected]
Dnyaneshwar Gawade Manager Training & Developement Sun Pharmaceutical Industries Ltd. Dewas, Non-US, India [email protected]
Dominick DiPaolo SVP Quality, Compliance & Regulatory Tris Pharma Monmouth Junction, NJ, United States [email protected]
Donato Barbato Researcher Advanced accelerator applications Turin, Non-US, Italy [email protected]
Donna Brandt Quality Control Manager Cosmetic Laboratories of America Chatsworth, CA, United States [email protected]
Donna Roney Manager Pfizer Richmond, VA, United States [email protected]
Dorcas Taylor Consumer Safety Officer FDA Silver Spring, MD, United States [email protected]
Doris Ng Regional Quality System Manager Celestica Asia Singapore, Non-US, Singapore [email protected]
Doris Ogrowsky Consultant Regylatory Specialists St. Louis, MO, United States [email protected]
Dorothea Murray Director of Chemical Research and Product Analysis American Pharmaceutical Ingredients Boca Raton, FL, United States [email protected] Dorothy Guidry
Director of Quality Capstone Nutrition-TN Spring Hill, TN, United States [email protected]
Doug Shaw Director of CSV & IT Consulting Azzur Group Annapolis, MD, United States [email protected]
Douglas Kline Principal Douglas Kline UG (haftungsbeschraenkt) Berlin, Non-US, Germany [email protected]
Dr. Matthias Grathwohl Head of Quality Management Swiss Caps AG Kirchberg, Non-US, Switzerland [email protected]
Dragana Males Medical Director ADAMIS PHARMACEUTICALS CORPORATION San Diego, CA, United States [email protected]
Dumbala Shashikanth Reddy Quality Manager Zhejiang Jiuzhou Pharmaceuticals Ltd Taizhou, Non-US, China [email protected]
Durgaprasad Erukulla Officer-Regulatory affairs Mylan hyderabad, Non-US, India [email protected]
Dwight Edghill QA Lead Horizon Pharmaceuticals' Inc. Riviera Beach, FL, United States [email protected]
Eberth Leopoldo Sarmiento Infantes EVALUATOR DIRECCIÓN GENERAL DE MEDICAMENTOS INSUMOS Y DROGAS DEL PERÚ LIMA, Non-US, Peru [email protected] Eddie Liu
TS senior director Sunny pharmtech Taoyuan, Non-US, Taiwan [email protected]
Edmund Mickunas Principal Consutant Regulatory Consulting Centerville, MA, United States [email protected]
Eduardo Maldonado Principal Officer EM Consulting Group Guaynabo, Non-US, Puerto Rico [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information
Edward Patt Principal Consultant Edward Patt LLC Lenoir, NC, United States [email protected]
EDWIN ESPINOZA GUTIERREZ PHARMACIST DIGEMID LIMA, Non-US, Peru [email protected]
Eileen Castillo QC Manager A.I.G. Technologies, Inc Deerfield Beach, FL, United States [email protected]
Eileen Daloia Director Regulatory Affairs Crown Laboratories Johnson City, TN, United States [email protected]
Elaine Scheye President The Scheye Group Ltd. Chicago, IL, United States [email protected]
Elangho Muthusamy Specialist Senior Registrar Rashid Hospital Dubai, Non-US, United Arab Emirates [email protected]
Elena Violeta Mendoza Arevalo ASISTENTE Ministerio de Salud PERU-DIGEMID LIMA, Non-US, Peru [email protected]
Elina N. Khachiyan Regulatory Compliance Specialist AIC Framingham, MA, United States [email protected]
Elisa Perdon Quality Assurance Directorf US Pharmaceutical Corporation Decatur, GA, United States [email protected]
Elizabeth Jumet Vice President Keystone Laboratories Memphis, TN, United States [email protected]
Elizabeth Mason Manager, Regulatory Affairs Haemonetics Corporation Covina, CA, United States [email protected]
Elizabeth Moyer CEO M/P Biomedical Consultants LLC Mill Valley, CA, United States [email protected]
Elizabeth Noble owner/consultant Elizabeth P. Noble, Inc. Salisbury, NC, United States [email protected]
Elizabeth Rita Gutierrez Valencia Practicing Universidad Nacional Mayor de San Marcos Lima, Non-US, Peru [email protected]
Elle Bard Paralegal HTC LLC South Lyon, MI, United States [email protected]
Ellen Camos Director ANI Pharmaceuticals Raleigh, NC, United States [email protected]
Ellen Lindner Sr. Regulatory Affairs Specialist University of Pennsylvania Philadelphia, PA, United States [email protected]
Emily Tash QA Manager Precision Nuclear Salem, VA, United States [email protected]
enrique pernas Manager ARD avevadds Miramar, FL, United States [email protected]
Eoin Walsh Director of Analytical Sciences Coda Corp USA Buffalo/Niagara, NY, United States [email protected]
Eric Song Quality Director Sagent pharmaceuticas (China) Pharmaceuticals Co., Ltd. Chngdu, Non-US, China [email protected] Eric White
Sr. VP Regulatory Affairs Mission Pharmacal Company Boerne, TX, United States [email protected]
Erica Weiss Administrative Assistant American Pharmaceutical Ingredients, LLC Boca Raton, FL, United States [email protected]
Erika Guzmán QA System Manager WellSpring Pharmaceuticals Sarasota, FL, United States [email protected]
Erin Achurch MQA Specialist Pfizer Saint Louis, MO, United States [email protected]
Esther Sur QA/RA Coordinator Iluminage Beauty Inc. New York, NY, United States [email protected]
EunSeon Yang Assistant manager Penmix Ltd. Seoul, Non-US, South Korea [email protected]
Eva Kabir Chairperson BRAC university Dhaka, Non-US, Bangladesh [email protected]
Evangeline Raguindin R&D/Regulatory Affairs Manager Diamond Wipes International, Inc. Chino, CA, United States [email protected]
Evin Aycicek Durak R&D Senior Specialist Researcher Biofarma Pharmaceutics Istanbul, Non-US, Turkey [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information
Farishta Barack Researcher Maryland Baltimore, MD, United States [email protected]
Farzad Parsaie Chief Operating Officer, GeNO LLC Cocoa, FL, United States [email protected]
Fatih Karademir Quality Assurance Manager ARGIS Ilac Co. Ankara, Non-US, Turkey [email protected]
Fei Cheng Regulatory Affairs Yiling Pharmaceutical Ltd Shijiazhuang, Non-US, China [email protected]
feifei liu QA engineering Luye pharmaceutical Yantai, Non-US, China [email protected]
Felix Morales Quality Assurance Supervisor Navajo Manufacturing Co. Inc. Denver, CO, United States [email protected]
FERNANDO VILCHEZ pharmacist sisol peru, PA, Peru [email protected]
Fiona Gould Regulatory Affairs Project Manager Quotient Edinburgh, Non-US, United Kingdom [email protected]
Forest Ford CSO FDA Silver Spring, MD, United States [email protected]
Frances King QA Manager TopChem Pharmaceuticals Sligo, Non-US, Ireland [email protected]
Francesca Knowles Quality Specialist Coda Corp USA Buffalo/Niagara, NY, United States [email protected]
Francesca Minale President AF Pharma Inc. Piscataway, NJ, United States [email protected]
Francisco Huerta Manager Laboratorios PISA SA de CV Guadalajara, Non-US, Mexico [email protected]
Francois Perreault lab supervisor - chemistry Galderma Montreal, Non-US, Canada [email protected]
francy elguera area manager Medikids Lima, Non-US, Peru [email protected]
FRANK PERRELLA Project Manager FDA/CDER Silver Spring, MD, United States [email protected]
Frantiescoli Dimer Formulation Researcher Instituto Vita Nova Hortolandia SP, Non-US, Brazil [email protected]
fray huamanyauri DRA Jr Coordinator Peru GSK Consummer Health Care Lima, Non-US, Peru [email protected]
frederick golec president cmcregaff, llc merion station, PA, United States [email protected]
frederick morgan none lianyungang runzhong pharmaceutical co.ltd
lianyungang，jiangsu，china, Non-US, China [email protected]
Frederick Simon Golec Jr PhD RAC President CMCRegAff, LLC merion station, PA, United States [email protected]
Frida Alcala Manager Laboratorios PISA SA de CV Guadalajara, Non-US, Mexico [email protected]
Gabriel Kaddu Senior GMP Specialist USP ROCKVILLE, MD, United States [email protected]
Gabriel Lebovic Vice President of Regulatory Affairs Global Regulatory Consulting, Ltd. Warminster, PA, United States [email protected]
Gabriela Miranda Orr Consultant Regulatory Affairs External Consultant Minneapolis, MN, United States [email protected]
Gale Dykes Director of Security Endo Pharmaceutical Rye, NY, United States [email protected]
Gamal Aberra Sr Manager, Fermentation/Purification DVC Vaccine LLC Frederick, MD, United States [email protected]
gaurav thakur officer dpcl ahmedabad, Non-US, India [email protected]
gaus khan senior vice president Abon pharmaceuticals LLC northvale, NJ, United States [email protected]
Geeta Routray Manager-Corporate Regulatory Affairs Piramal Enterprises Limited Mumbai, Non-US, India [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information
Geetanjali Jaguste Sr. Manager Regulatory Affairs Lupin Pharmaceuticals Inc Baltimore, MD, United States [email protected]
George Chang Pharmacologist FDA Silver Spring, MD, United States [email protected]
George Cobos QC Manager Paramount Cosmetics, Inc. Clifton, NJ, United States [email protected]
George Efthyvoulos QC Manager GR Foothill Ranch, CA, United States [email protected]
George Waterhouse President BioPharm Compliance, Inc Dunn, NC, United States [email protected]
Georgina Lo GxP Compliance Manager BioMarin Pharmaceuticals Novato, CA, United States [email protected]
Gina Guido-Redden COO Coda Corp USA Buffalo/Niagara, NY, United States [email protected]
GINA ROEBKE EXECUTIVE ASSISTANT LNK INTERNATIONAL, INC. HAUPPAUGE, NY, United States [email protected]
Giridhar Prasad Jangly Regulatory Affairs Associate Dr. Reddy's Laboratories Inc. Princeton, NJ, United States [email protected]
Girish Koni Chemist Guardian Drug Company Dayton, NJ, United States [email protected]
Gladys Martin Regulatory Affairs Manager Romark Laboratories, LC Tampa, FL, United States [email protected]
Glenn Huang Principal Scientist Icon Bioscience, Inc. Sunnyvale, CA, United States [email protected]
gonzalo carranza pharmacist digemid Lima, Non-US, Peru [email protected]
GOPAL PATEL Regulatory Affairs Specialist Navinta LLC Ewing, NJ, United States [email protected]
Govindaswamy Periyannan Group leader Corporate quality assurance Advinus Therapeutics Ltd. Bengaluru, Non-US, India [email protected]
Gregory Pollieri Manufacturing Engineer Intern Celestica Inc. Toronto, Non-US, Canada [email protected]
Gregroy Burke Self employed GBB, LLC Saint Louis, MO, United States [email protected]
Gunjan Vanarase Sr. Manager, Corporate Quality and Compliance G&W Laboratories, Inc South Plainfield, NJ, United States [email protected] Guravaiah Nalajam
Manager Hisun Pharmaceutical ltd Taizhou, Non-US, China [email protected]
habibeh mahboobi RPH howard university hospital McLean, NV, United States [email protected]
Hammad Ali Officer Regulatory Affairs PharmEvo Pvt. Ltd. Karachi, Non-US, Pakistan [email protected]
Hana Boudiaf Regulatory Affairs Medincell Cambridge, MA, United States [email protected]
Harikishan Komma Head _ Regulatory Affairs Caplin Point Laboratories Limited Chennai, Non-US, India [email protected]
Harish Cherivirala Sr. Manager Abon Pharmaceuticals Northvale, NY, United States [email protected]
harish varma Formulation scientist appcurelabs Hyderabad, Non-US, India [email protected]
Harshitha Talluri Regulatory Affairs Associate Appco Pharma somerset, NJ, United States [email protected]
Heather Dillon Quality Training Specialist Romark Laboratories, L.C. Tampa, FL, United States [email protected]
Heather Gingerich Regulatory Affairs Associate Sun Pharmaceutical Industries, Inc. Bryan, IN, United States [email protected]
Heather Pratt Manager, Regulatory & Clinical Affairs Macopharma Duluth, GA, United States [email protected]
Heemin Rhee President Health Research International North Potomac, MD, United States [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information
Heeyoung Park Sr. Manager, Regulatory Affairs Turing Pharmaceuticals New York, NY, United States [email protected]
Helen Hao Regulatory Affairs Manager CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. Shijiazhuang, Non-US, China [email protected]
Helen Sun Associate Director, Regulatory Affairs Bausch Bridgewater, NJ, United States [email protected]
Helen Zhang DMF Specialist Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd Hangzhou, Zhejiang, China, Non-US, China [email protected]
Hemant Wedhane Asst. Manager Ajanta Pharma Ltd Bharuch, Non-US, India [email protected]
Henry Lapoint Operations Manager Astecal Lima, Non-US, Peru [email protected]
Hezuo Zhao QA Supervisor BrightGene Pharmaceutical Co.,Ltd. Suzhou, Non-US, China [email protected]
Himanshu Jain QA Manager, PDS Contract Pharmaceuticals Limited Canada Mississauga, Non-US, Canada [email protected]
Hippolitus Odukwu Director of QA & Regulatory Affairs Angelini Pharma Inc. Gaithersburg, MD, United States [email protected]
Hira Shariq Sr. Executive Quality Control Getz Pharma Karachi, Non-US, Pakistan [email protected]
hira shariq Sr. Executive QC Getz Pharma Karachi, Non-US, Pakistan [email protected]
hiren patel QUALITY ASSOCIATE kashiv pharma BRIDGEWATER, NJ, United States [email protected]
Hiren Shah General Manager Wockhardt ltd Ankleshwar, Non-US, India [email protected]
hirenkumar sonani Sr. Scientist I Kashiv Pharma LLC Bridgewater, NJ, United States [email protected]
Hirofumi Kawai Manager Kyowa Hakko Kirin Pharma, Inc. Princeton, NJ, United States [email protected]
Hong Chen vp of R&D Yiling Pharmaceutical shijiazhuang, Non-US, China [email protected]
Hongfei Yue chemist FDA silver spring, MD, United States [email protected]
Hongmei Li reviewer FDA/CDER Silver spring, MD, United States [email protected]
Hu Haining Associate Gilead Shanghai, Non-US, China [email protected]
hui zhang RA officer Beijing Yiling Bio-engineering Technology Co., Ltd Beijing, Non-US, China [email protected]
Ian Hardy CMC Director TetraLogic Pharmaceuticals Malvern, PA, United States [email protected]
Ilango Thangavelu Functional Test developer Celestica Toronto, Non-US, Canada [email protected]
Imtiyaz Ubharay Manager R&D-QA Tris Pharma Inc. Monmouth Junction, NJ, United States [email protected]
Inigo Pfeiffer Director Pharma & Biomed AmRuss Kernersville, NC, United States [email protected]
Inna Strakovsky Sr. Regulatory Affairs Specialist University of Pennsylvania Philadelphia, PA, United States [email protected]
Irene Banas Regulatory Manager Delaval Manufacturing Bannockburn, IL, United States [email protected]
Irene Ng QA Manager Celestica Electronics (M) Johor Sdn Bhd Johor, Non-US, Malaysia [email protected]
Irene Rao QRA Specilaist Stanford Blood Center Palo Alto, CA, United States [email protected]
Isabel Cisneros Regulatory Affairs RGR Pharma Ltd Windsor, Non-US, Canada [email protected]
Isabella Schmitt Regulatory Affairs Associate Repros Therapeutics The Woodlands, TX, United States [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information
Ismahan Ugas Clinical Trial Administrator NCI Rockville, MD, United States [email protected]
Izabela Rejdych Regulatory Affairs Manager AAA Saint Genis Pouilly, Non-US, France [email protected]
Jabid Lotero Regulatory Affairs Anakyst Procaps S.A Barranquilla, Non-US, Colombia [email protected]
Jack Zheng Regulatory Affairs Ruby Pharma Duluth, GA, United States [email protected]
Jacki O'Leary Regulatory Affairs Specialist Ocular Therapeutix Bedford, MA, United States [email protected]
Jacob Berns Manager, Technical Affairs Interchem Corp Paramus, NJ, United States [email protected]
Jacob Wendling Training Coordinator SPI Pharma Grand Haven, MI, United States [email protected]
jacqueline crawford Manager, Quality Systems Catalent Pharma Soluitions- RTP Morrisville, NC, United States [email protected]
Jacques Mowrer Director Analytical Development Threshold Pharmaceuticals South San Francisco, CA, United States [email protected]
Jagdamba Prasad Manager Sigmapharm laboratories Bensalem, PA, United States [email protected]
Jalal Jafri CEO & President DS Technologies Darien, CT, United States [email protected]
James Brown Senior regulatory manager Goldbelt Raven LLC Frederick, MD, United States [email protected]
james cox Sr Analytical Chemist/ Lab Supervisor Thibiant Chattsworth, CA, United States [email protected]
James Duffy Supplier Quality Manager Perrigo Minneapolis, MN, United States [email protected]
James Kang Manager Neo Kimchi Bio-Active, Inc. San Jose, CA, United States [email protected]
James Whitehead VP Quality and Regulatory Affairs Reliable Biopharmaceutical Corp Saint Louis, MO, United States [email protected]
Jami Knight Analytical Chemist IGI Labs, Inc. Buena, NJ, United States [email protected]
Janak Patel AGM Quality Unit Halcyon Labs Private Limited Ahmedabad, Non-US, India [email protected]
Jane xiang Manager of Product Development Flavine North America, Inc Closter, NJ, United States [email protected]
Janice Vu Quality control EO products San Rafael, CA, United States [email protected]
Janie Russell Regulatory Affairs Specialist NIH Bethesda, MD, United States [email protected]
Jannina Suxe Ramirez Químico Farmaceutico Dirección de Medicamentos Insumos y Drogas Lima, Non-US, Peru [email protected]
Jason Alba Sr. Manager Domain WIPRO Irvine, CA, United States [email protected]
Jason Edwards Packaging Supervisor IGI Laboratories, Inc. Buena, NJ, United States [email protected]
Jason Gillette VP of Regulatory Compliance Westminster Pharmaceuticals, LLC Odessa, FL, United States [email protected]
Javorka Gunic QA Manager Evofem Inc San Diego, CA, United States [email protected]
Jay Tanna Associate Consultant EY Mumbai, Non-US, India [email protected]
Jaya Dhiman Dhiman Corporate Quality Assurance Sentiss Pharma Pvt Ltd Gurgaon, Non-US, India [email protected]
Jayashree Patel Sr. Regulatory compliance associate Teva pharmaceutical US Pomona, NY, United States [email protected]
Jean Crawford QA/Medical Affairs Specialist Nostrum Laboratories Inc. Kansas City, MO, United States [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information
Jean Crawford QA/Medical Affairs Specialist Nostrum Laboratories Inc Kansas City, MO, United States [email protected]
Jeannine Ramsey Consultant Accurate Clinical Solutions Wellington, OH, United States [email protected]
Jeffrey Fenerty Executive Director of Sterile Compounding Pharmalogic CSP Bridgeport, WV, United States [email protected]
Jen Pendlebury Dector, Regualtory Affairs Novadaq Technologies Mississauga, Non-US, Canada [email protected]
Jena Strauss-Schoenberger Regulatory Affairs Associate ISTO Technologies, Inc. St. Louis, MO, United States [email protected]
Jeness Jose Associate III- Regulatory Affairs sandoz Princeton, NJ, United States [email protected]
Jenn Snodgrass Director QC Labs PD Pharmatech Seymour, IN, Afghanistan [email protected]
Jennie Allewell Sr Director Regulatory Affairs Cambrex Corporation East Rutherford, NJ, United States [email protected]
jennifer chenault QA kppt bloomington, IN, United States [email protected]
Jennifer Bakula Senior Quality Manager Akorn Pharmaceuticals Lake Forest, IL, United States [email protected]
jennifer chenault QA kp pharmaceutical bloomington, IN, United States [email protected]
Jennifer Chmura Quality Assurance Associate Pharmaceutics International, Inc. Hunt Valley, MD, United States [email protected]
Jennifer Fetterolf Sr. Manager, Quality Assurance Chiesi USA, Inc. Cary, NC, United States [email protected]
Jennifer Morgan Manufacturing Manager Osiris Therapeutics, Inc. Columbia, MD, United States [email protected]
Jennifer Morgan Manufacturing Manager Osiris Therapeutics Columbia, MD, United States [email protected]
Jennifer Sensenig Clinical Research Coordinator The Ohio State University Medical Center Columbus, OH, United States [email protected]
Jennifer Sievers Quality Director Apothecares Supply Decatur, AL, United States [email protected]
Jenny (Shun Yin) Fong Head of Compliance Hovione LLC East Windsor, NJ, United States [email protected]
JENNY RAO Regulatory Specialist Shenzhen Hepalink Pharmaceutical Ltd., Co. Shenzhen, Non-US, China [email protected]
Jenny Steele Repack Specialist Apotheca Supply, Inc. Decatur, AL, United States [email protected]
Jeremy Richardson Complaint Coordinator Telcare Medical Supply Concord, MA, United States [email protected]
Jerilyn Spencer Quality Assurance Manager Horizon Pharmaceuticals, Inc. Riviera Beach, FL, United States [email protected]
Jerry Brandewie Consultant IBTS Spring, TX, United States [email protected]
Jessica Haas Assistant Quality Manager Powdersize, Inc. Quakertown, PA, United States [email protected]
Jessica VanKirk Chemist Next Science, LLC Jacksonville, FL, United States [email protected]
Jessica VanMeter Sr. RA Specialist Qualitest Huntsville, AL, United States [email protected]
Jessika Lima de Azevedo Quality Assurance Auditor Prati Donaduzzi Ltda Toledo, Non-US, Brazil [email protected]
Jessika Lima de Azevedo Quality Assurance Auditor Prati DOnaduzzi Ltda Toledo, Non-US, Brazil [email protected]
jhonathan israel gonzález acosta asistente de producción laboratorio medrock corperation S.A lima, Non-US, Peru [email protected]
Jia Wang QA Analyst PuraCap Pharmaceutical LLC South Plainfield, NJ, United States [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information
Jianhua Tang Manager Dynport vaccine llc Frederick, MD, United States [email protected]
Jieun Lee Associate Celltrion Pharm Cheongju-si, Non-US, South Korea [email protected]
jigisha varia Senior Manager, Reg Affairs Evenus Pharmaceutical Industries Inc Princeton, NJ, United States [email protected]
Jillian Collins Sr. QA Specialist Charles River Laboratories Charleston, SC, United States [email protected]
Jingran Lu regulatory speclist prinston pharmacutical East Windsor, NJ, United States [email protected]
Jinjie Hu Senior Consultant BCG Alexandria, VA, United States [email protected]
Jinous Saeedi Sr.Specialist RA/QA Irvine Pharmaceutical Services Irvine, CA, United States [email protected]
Jinseok Jeon General Manager BCWorld Pharm. Co., Ltd. Seoul, Non-US, South Korea [email protected]
Jitendra Parmar Production Manager Bio-Pharm Inc. Levittown, PA, United States [email protected]
Jo Collins Manager, Quality Clinical Compliance Ora, Inc. Andover, MA, United States [email protected]
Joachim Troost Senior Associate Director Boehringer Ingelheim Ridgefield, CT, United States [email protected]
Joan Fanis QA Manager Sterile Forms Rafarm S.A. Athens, Non-US, Greece [email protected]
Joanne Marriott Sr, VP Quality Amerigen Pharmaceuticals Inc Lyndhurst, NJ, United States [email protected]
Joaquin Perez Manager Laboratorios Pisa SA de CV Jalisco, Non-US, Mexico [email protected]
Joe Murphy Director, Combination Products Compliance Janssen Pharmaceuticals Neuchatel, Non-US, Switzerland [email protected] Joel Selcher
Head of Regulatory Strategy Jazz Pharmaceuticals, Inc. Palo Alto, CA, United States [email protected]
Joey Hu Regulatory Affairs CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. Shijiazhuang, Non-US, China [email protected]
John F Ekpe Manager, Clincal Chemistry TUH Philadelphia, PA, United States [email protected]
John Kim VP Quality, Regulatory and Viligance Pierre Fabre Pharmaceuticals, Inc. Parsippany, NJ, United States [email protected]
John Lester IT & Facilities Manager ImmunoScience, Inc Pleasanton, CA, United States [email protected]
John Maddalena Quality Director Haemtech Biopharma Services Essex Junction, VT, United States [email protected]
John Metcalfe Senior Microbiology Reviewer FDA Silver Spring, MD, United States [email protected]
John Miller VP US Compliance Fresenius Kabi Lake Zurich, IL, United States [email protected]
John Oberholtzer Senior Regulatory Affairs Manager Celerity Pharmaceuticals, LLC Bartlett, IL, United States [email protected]
john punzi Director QA and Tech Affairs chpa Wash, DC, United States [email protected]
john punzi Dir QA/ TECH AFFAIRS chpa washigton, DC, United States [email protected]
Jon Beaver Vice President of Quality Control Focus Laboratories, Inc. North Little Rock, AR, United States [email protected]
Jonas Kazmirczak Analist of Supplier Qualification Prati Donaduzzi Toledo, Non-US, Brazil [email protected]
jose brenis jefe de produccion lab. Medrock corp. Lima, Non-US, Peru [email protected]
José Luis Correa Vásquez EVALUATOR DIRECCIÓN GENERAL DE MEDICAMENTOS INSUMOS Y DROGAS DEL PERÚ LIMA, Non-US, Peru [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information
Joshua McCartney QA Auditor I Charles River Laboratories Charleston, SC, United States [email protected]
Joy Frestedt President and CEO Frestedt Incorporated Saint Louis Park, MN, United States [email protected]
Joy Trepanier QA Manager Hill Dermaceuticals Inc Sanford, FL, United States [email protected]
Joyce Frey-Vasconcells Regulatory Consultnat Frey-Vasconcells Consulting, LLC Sykesville, MD, United States [email protected]
Joyce Nwangwa Sr. Quality Systems Specialist Catalent Pharma Solutions Morrisville, NC, United States [email protected]
JS REDDY HEAD QUALITY HONOUR LAB LTD VISHAKAPATNAM, Non-US, India [email protected]
Juan He Senior Director, Pharmacometrics BioPharma Services Inc. Toronto, Non-US, Canada [email protected]
JUAN BOTANA GMP-COMPLIANCE HEAD INKE BARCELONE, Non-US, Spain [email protected]
Juan Gutierrez Manager Laboratorios Pisa SA de CV Jalisco, Non-US, Mexico [email protected]
Juan Manuel Reategui Torrejon Quimico Farmaceutico Independiente Lima, PA, Peru [email protected]
Juan Olivares León Head of Quality And Regulatory Affairs Siemens Lima, Non-US, Peru [email protected]
Juan Zha RA, deputy director Zhejiang Medicine Co., Ltd. Xinchang Pharma Xinchang, Zhejiang, Non-US, China [email protected] Judith Cohen
Director Quality Particle Sciences Inc Bethlehem, PA, United States [email protected]
Judith Samardelis Global IT Quality and Compliance Astrazenca Gaithersburg, MD, United States [email protected]
Judy McMeekin Staff Director, Medical Products and Tobacco Policy FDA/ORA Silver Spring, MD, United States [email protected] Julia Griselda Sarmiento
EVALUADOR DIGEMID LIMA, Non-US, Peru [email protected]
Julia Zhu R&A Manager Flavine Shanghai, Non-US, China [email protected]
Juliana Rodriguez PHARMACIST DIGEMID LIMA, Non-US, Peru [email protected]
Julie Gerlach Clinical Division Director Compliance Insight Inc. Fairfield, OH, United States [email protected]
Julienne Pearson Regulatory associate Teva Woodcliff Lake, NJ, United States [email protected]
JULIO CASTAÑEDA FARMACEUTICO DIGEMID LIMA, Non-US, Peru [email protected]
Julivet Nuñez Biotechnologist Medistem Panama Inc Panamá, Non-US, Panama [email protected]
Jun Gao Director, Global Alliance Management Sagent Pharmaceuticals, Inc. Schaumburg, IL, United States [email protected]
Junle Ren Senior R&D engineer Yiling Pharmaceutical Ltd Shijiazhuang, Non-US, China [email protected]
Justyna Mazur QA/QC Manager OHM Pharma, Inc. Mineral Wells, TX, United States [email protected]
Jyothi Matharu VP, Quality KP Pharmaceutical Technology I Bloomington, IN, United States [email protected]
Kaci Rosales Quality Assurance and Regulatory Affairs Specialist Allergy Laboratories, Inc. Oklahoma City, OK, United States [email protected] Kairon Nóbrega Riguete
Project Management Prati Donaduzzi Toledo, Non-US, Brazil [email protected]
Kaitlyn Riffel Consultant, Scientific Consulting Cardinal Health Overland Park, KS, United States [email protected]
KALYANI TAMMAREDDY QUALITY SYSTEMS MANAGER JOHNS HOPKINS UNIV BALTIMORE, MD, United States [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information
kamal elsayed G M innovation corporation LTD Cairo, CA, Egypt [email protected]
Kamal Negi Quality Assurance Sentiss Pharma Pvt. Ltd. Gurgaon, Non-US, India [email protected]
Kamana Singh NA NA Chalfont, PA, United States [email protected]
Kandi Hall Quality Assurance Manager NAMSA Northwood, OH, United States [email protected]
Karan Khairnar Quality management System Wockhardt Ltd Aurangabad, Non-US, India [email protected]
Karen Barmore Compliance Team Leader Colgate-Palmolive Greenwood, SC, United States [email protected]
Karen Cui Biologist NIH Bethesda, MD, United States [email protected]
Karen Metcalfe Director, Regulatory Affairs DVC Frederick, MD, United States [email protected]
Karen Rojas Tamata practicing universidad católica de santa maría Arequipa, Non-US, Peru [email protected]
Karen Zimm Associate Director CMC Reg Affairs Johnson & Johnson Titusville, NJ, United States [email protected]
Karin Au QA and RA Specialist Scynexis Research Triangle Park, NC, United States [email protected]
Karl Scott Senior Manager, Compliance Johnson & Johnson Ratitan, NJ, United States [email protected]
Karm Chand Panday QA Validation Celestica Singapore, Non-US, Singapore [email protected]
karoll Gonzalez QS Compliance Analyst Stryker FT. Lauderdale, FL, United States [email protected]
Kartick Das Manager, Audit & Assurance GlaxoSmithKline Bangladesh Ltd Dhaka, Non-US, Bangladesh [email protected]
kasaiah valaparla RA Associate Novo Nordisk Bangalore, IN, India [email protected]
Kasinath Baratam Sr. Executive-Regulatory Affairs Raks Pharma Pvt. Ltd. Vishakapatnam, Non-US, India [email protected]
Kate Fang Regulatory Affairs Specialist Yung Shin Pharm. Ind. Co., Ltd. Taichung, Non-US, Taiwan [email protected]
Katerina Kazakou QA/QC Director RAFARM Athens, Non-US, Greece [email protected]
Katherine DeHaven QA Specialist Ultra Tab Laboratories Highland, NY, United States [email protected]
Katherine Seifert President Seifert & Associates Ventura, CA, United States [email protected]
Katia Melnik RA Specialist G Production Inc. Baie d'Urfé, Non-US, Canada [email protected]
Katie Dougherty Principal Adjusta Consulting Maple Glen, PA, United States [email protected]
Katie Jackson Manager Avalere Health Washington, DC, United States [email protected]
Katie Keathley QA Manager Nostrum Laboratories Kansas City, MO, United States [email protected]
Katrina Smith QA/QC Specialist JHU Cell Processing and Gene Therapy Facility Baltimore, MD, United States [email protected]
Kaushik Patel Regulatory Affairs Associate II Teva Pharmaceuticals Horsham, PA, United States [email protected]
Kaustubh Gavaskar VP, Quality and Regulatory Affairs Bio-Pharm Inc Levittown, NJ, United States [email protected]
Kay Mitchen Director of Regulatory Affairs Natural Immunogenics Corp Sarasota, FL, United States [email protected]
Kazuyuki Atarashi Global Program Manager MBL International Woburn, MA, United States [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information
Keith Michels Operations Manager IGI Labs, Inc. Buena, NJ, United States [email protected]
Keith Mills Director of Research and Research Analyst Trillium Asset Management Boston, MA, United States [email protected]
Kelly Garcia Analyst Pratidonaduzzi Toledo, Non-US, Brazil [email protected]
Kelly Key Quality Assurance Manager Endo/Qualitest Pharmaceuticals Huntsville, AL, United States [email protected]
ken nolan Senior Advisor USFDA Silver Spring, MD, United States [email protected]
Kenneth Petersen Regulatory Associate II Teva Pharmaceuticals Horsham, PA, United States [email protected]
Kenny Rogge Reg Affairs and Quality Process Extension Healthcare Fort Wayne, IN, United States [email protected]
Kerri FitzSimmons Project Logistics CoreRx, Inc. Clearwater, FL, United States [email protected]
Ketty Rocio Balabarca Padilla Pharmacits DIGEMID Lima, Non-US, Peru [email protected]
Ketul Khamar Quality System Specialist Purdue Pharma Cranbury, NJ, United States [email protected]
Kevin Huang Sr. Manager Kashiv Pharma Bridgewater, NJ, United States [email protected]
Khemraj Hirani Director, Regulatory affairs and quality assurance University of Miami miller school of medicine Miami, FL, United States [email protected]
Khurram Khan Regulatory Affairs Manager Blu Pharmaceuticals Franklin, KY, United States [email protected]
Kim HuynhBa Executive Director Pharmalytik Newark, DE, United States [email protected]
Kimberly Ezdebski Vice President Quality & Reg Compliance Chartwell Pharmaceuticals Congers, NY, United States [email protected]
Kimberly Grevera Regulatory Affairs Manager GeNO LLC Cocoa, FL, United States [email protected]
Kimberly Patterson Associate Director WES Pharma, Inc. Westminster, MD, United States [email protected]
Kimberly Stidd QA Manager KP Pharmaceutical Bloomington, IN, United States [email protected]
kinjal joshi Sr. Manager-QA Sun Pharmaceutical Industries Ltd Gurgaon, Non-US, India [email protected]
Kinjal Mehta Associate - Regulatory Affairs Sancilio & Company, Inc, Mumbai, FL, India [email protected]
Kinn Chan Director Regulatory Affairs Torrent Pharma Inc. Kalamazoo, MI, United States [email protected]
KIRAN KOLHE ASSOCIATE VP - RA MICRO LABS LIMITED BANGALORE, Non-US, India [email protected]
Kirankumar Kota Quality Auditor Azbil Telstar India Pvt. Ltd., Hyderabad, Non-US, India [email protected]
Kishore Addanki Assistant Manager Mylan Laboratories LImited hyderabad, Non-US, India [email protected]
Korben Knudson Project Specialist RMC Pharmaceutical Solutions Longmont, CO, United States [email protected]
krishna chilakamarthy Associate Director Sciegen Pharmaceuticals Hauppauge, NY, United States [email protected]
Kristen Schroeder OPERATIONS MANAGER Vita Key Packaging, Inc. Riverside, CA, United States [email protected]
Kristen Snaguski Quality Assurance Associate Pierre Fabre Parsippany, NJ, United States [email protected]
Kristine Khurshudyan Quality Specialist Esco-Pharm Ltd. Yerevan, Non-US, Armenia [email protected]
Kristine Khurshudyan Quality Specialist Esco Pharm Glendale, CA, United States [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information
Kwok Wu VP of Quality & RA Yiling Pharmaceutical Ltd Shijiazhuang, Non-US, China [email protected]
Lakshmikanth Maddela Manager - Regulatory Affairs Daewoong Pharmaceutical Co. Ltd. hyderabad, Non-US, India [email protected]
Lara Noah Director, Regulatory Affairs Nexgen Pharma Irvine, CA, United States [email protected]
Laura Kendrick Regulatory Specialist American Health Packaging Columbus, OH, United States [email protected]
Laura Lamas Quality Assurance Assistant Manager Pharmalabenterprises Miami, FL, United States [email protected]
LAWRENCE EMERE COMPLIANCE MANAGER PREPHARM EWING, NJ, United States [email protected]
Leah Choi Project Specialist RMC Pharmaceutical Solutions Longmont, CO, United States [email protected]
leah kleyn QA Director geri-care pharm Brooklyn, NY, United States [email protected]
Leanne Sleer Senior Medical Writer INC Research Washington, DC, United States [email protected]
leo su manager sunnypharmtech New taipei city, Non-US, Taiwan [email protected]
Leona Saunders Head of RA & QA Curis Lexington, MA, United States [email protected]
Leonard Krause President FDA Connect, Inc. Eugene, OR, United States [email protected]
Levi Li Regulatory Affairs CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. Shijiazhuang, Non-US, China [email protected]
li qiao VP Handa Pharmaceuticals Fremont, CA, United States [email protected]
Lijie Wang Manager, Regulatory Affairs Actavis Parsippany, NJ, United States [email protected]
Lily Cueva Narro farmaceutico digemid LIma, Non-US, Peru [email protected]
Lin Ping research scientist Jiangsu Simcere Pharmaceutical Group,China Nanjing, Non-US, China [email protected]
Lin Sun Specialist of RA Yiling Pharmaceutical Ltd Shijiazhuang, Non-US, China [email protected]
Linda McGovern Quality Assurance Manager SterRx LLC Plattsburgh, NY, United States [email protected]
Linwood Rayford Attorney SBA Office of Advocacy Washington, DC, United States [email protected]
Lisa Murray Director of Operations Provenir Garnet Valley, PA, United States [email protected]
Lisa Poon-Chuk RA & PV Associate Citron Pharma, LLC. East Brunswick, NJ, United States [email protected]
lisa tan associate vp of scieces and regulatory affairs GPhA washington dc, DC, United States [email protected]
Lisa Yin Regulatory Affairs Chengdu Easton Pharmaceutical Co., Ltd. Chengdu, Non-US, China [email protected]
Lori de los Reyes Sr. Manager, Global Regulatory Affairs, Device Amgen Thousand Oaks, CA, United States [email protected]
Lou Diorio Prinicpal LDT Health Solutions wayne, NJ, United States [email protected]
Lourdes Montanez Regulatory Affairs Specialist Neolpharma, Inc. Caguas, Non-US, Puerto Rico [email protected]
Lucja Orzechowski Quality Assurance Auditor Lohmann Therapy Systems West Caldwell, NJ, United States [email protected]
Luis Carlos Moschetta Supplier Qualification Team Leader Prati, Donaduzzi & Cia Ltda Toledo, Non-US, Brazil [email protected]
LUIS VELASQUEZ licenciado en biología LMB H.COLICHON S.A.C lima, Non-US, Peru [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information
Luke Sadowski Plant Manager Hill Dermaceuticals Sanford, FL, United States [email protected]
Ma Kaihua Deputy Manager Zhejiang Huahai Pharmaceutical Co,. Ltd. Neijiang, Non-US, China [email protected]
maha lakshmi Regulatory Affairs RAKS PHARMA PRIVATE LIMITED Vishakhapatnam, Non-US, India [email protected]
mahesh reddy jonnala research associate gland pharma limited hyderabad, Non-US, India [email protected]
mahmoud ghannam R&D Project leader Hikma pharmaceuticals Amman, Non-US, Jordan [email protected]
Maira Adzema Director Quality Assurance IPM Silver Spring, MD, United States [email protected]
maithili golhar complaint investigator PL Developments westbury, NY, United States [email protected]
Majid Hasheminejad President 4-1-1 Consulting Services, LLC York, PA, United States [email protected]
Malini Batheja VP of Analytical R&D and Regulatory CMC Saptalis Pharmaceutical HAUPPAUGE, NY, United States [email protected]
Manikanta K DRA Executive Gland Pharma Limited Hyderabad, IN, India [email protected]
Manish Bhatt Quality Manager Colgate Palmolive Morristown, TN, United States [email protected]
Manish Sapkota Quality control officer Alive Pharmaceuticals Biratnagar, Non-US, Nepal [email protected]
Manjunathan Ranganathan Microbiologist Caplinpoint Laboratories limited Chennai, TN, India [email protected]
Mankit Ho Senior Vice President Kashiv Pharma, LLC Bridgewater, NJ, United States [email protected]
Marada Satyanarayana Jr.Officer-Regulatory Affairs Raks Pharma Pvt. Ltd. Visakhapatnam, Non-US, India [email protected]
Marcela Saad President & Senior Consultant MarcM Consulting Canada Kitchener, Non-US, Canada [email protected]
Marcela Spelz Project Coordinator PiSA Farmaceutica Guadalajara, Non-US, Mexico [email protected]
Marcia Howard Senior Director, Regulatory & Scientific Affairs Consumer Healthcare Products Association Washington, DC, United States [email protected] Marcy Wylie
Sr. Compliance Auditor Catalent Pharma Solutions Morrisville, NC, United States [email protected]
Margaret Choy EVP, Regulatory Affairs & Compliance Pharmadax USA, Inc. Irvine, CA, United States [email protected]
Maria Consuelo Neyra Cabezudo Quimico Farmaceutico DIGEMID- PERU Lima, Non-US, Peru [email protected]
Maria Caturla Clinical Research Monitoring Specialist University of Pennsylvania Philadelphia, PA, United States [email protected]
Maria Ferreira Quality Assurance Director Laboratorios PiSA SA de CV Guadalajara, Non-US, Mexico [email protected]
Maria Isabel Quicano Velasquez Assistant Pharmacist QUIMFA PERU SAC Lima, Non-US, Peru [email protected]
Maria McGarry Founder biolicensure montclair, NJ, United States [email protected]
Mariam Shokralla project manager Egyptian Drug Authority Rockville, MD, Egypt [email protected]
Marianne Scheffler President Scheffler & Associates Carmel, NY, United States [email protected]
Marie Dorat Principal Consultant/CEO IPRF, LLC San Diego, CA, United States [email protected]
Marietsy Pujol Research Analyst University of Miami Miami, FL, United States [email protected]
MARIO DEL TORO Manufacturing Operations Director Pisa Farmaceutica S.A de C.V. Guadalajara, Jalisco, Non-US, Mexico [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information
Mariola Mier Executive Consultant Pharma Quality Europe Mexico, Non-US, Mexico [email protected]
Marisol Rodriguez QA and QC Manager Interquim S.A. de C.V. Cuautitlan Izcalli, Non-US, Mexico [email protected]
Marissa Cordo Regulatory Affairs Associate Teva Pharmaceuticals USA Horsham, PA, United States [email protected]
Maritza Marquez Document Specialist Roche Tissue Diagnostics Tucson, AZ, United States [email protected]
Maritza Sosa Jimenez Quality and Compliance Prime Enterprises, Inc. Miramar, FL, United States [email protected]
Mark Hendrickson Dir Reg Sci GPhA Washington, DC, United States [email protected]
Mark Mitcher VP Quality Assurance ChemAid Laboratories Saddle brook, NJ, United States [email protected]
Mark Wita VP QA RA Pharmaceutical Associates, LLC Tampa, FL, United States [email protected]
Marla Tegtmeier QA Cordinator HP Enterprise Des Moines, IA, United States [email protected]
Marta Lisiakiewicz Research Associate MedinCell Jacou, Non-US, France [email protected]
Martine Poisson Validation supervisor Galderma Baie d'Urfé, Non-US, Canada [email protected]
Marvin Garrett Vice President Aerie Pharmaceuticals Irvine, CA, United States [email protected]
Mary Bame Senior Specialist: Auditing and Document Control Mylan Pharmaceuticals Greensboro, NC, United States [email protected]
Mary Clark General Manager PharmaGenetico San Antonio, TX, United States [email protected]
Mary Foster Managing Director Pharma Consulting - The Foster Group Blue Bell, PA, United States [email protected]
Mary Wood Regulatory/Quality BioConvergence Bloomington, IN, United States [email protected]
Marycarmen Nieto Director QA Pisa-Biopharm Albany, NY, United States [email protected]
Marycarmen Nieto Director of QA/RA Pisa Biopharm Albany, NY, United States [email protected]
Masayoshi Nishiyama owner Nishiyama Consulting Office Tokyo, Non-US, Japan [email protected]
MATHEW GEORGE General Manager Cadila Healthcare Limited Vadodara, Non-US, India [email protected]
MATILDE HUARI MARIN evaluador DIGEMID-MINSA Lima, Non-US, Peru [email protected]
Matt Cohen Director of Technical Services SA Analytical MUNDELEIN, IL, United States [email protected]
Matt Potter QA Pharmacist Roadrunner Pharmacy Phoenix, AZ, United States [email protected]
Maureen Kozuch Regulatory Manager Dow Chemical Midland, MI, United States [email protected]
Maurice Briggs Principal GMB Bio:Pharma Development Harleysville, PA, United States [email protected]
Maya Kharawala Director of Analytical/Quality Orit Laboratories LLC West Caldwell, NJ, United States [email protected]
Mayra Guzman-Kaslow President GK Regulatory Complaince & Enginering Consulting LLC West Palm Beach, FL, United States [email protected]
Meena Surana Director, QA & RA Polygen Pharmaceutcials LLC Edgewood, NY, United States [email protected]
Meenakshi Muthiah Regulatory Operations Specialist DynPort Vaccine Company LLC Frederick, MD, United States [email protected]
Meghan Heffernan Quality Control Supervisor IGI Labs, Inc. Buena, NJ, United States [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information
Mehul Gandhi QA Manager NLI Kansas City, MO, United States [email protected]
Mehwish Saeed Senior Executive Quality Assurance Documentation Scilife Pharma (Pvt.) Limited Karachi, Non-US, Pakistan [email protected]
Meifang Jiang Director of Quality Control Lab Xttrium Laboratories, Inc. Mount Prospect, IL, United States [email protected]
Melissa Basnight Director Regulatory & Quality LifeScience Logistics Dallas, TX, United States [email protected]
Melissa McMichael Quality Assurance Auditor Alliance Pharma Malvern, PA, United States [email protected]
Melody Tsai GMP Processing Supervisor TissueTech, Inc Doral, FL, United States [email protected]
Michael Mackie QC Laboratory Supervisro Xttrium Laboratories Mount Prospect, IL, United States [email protected]
Michael Ayeni QA Compliance Specialist Johnson Matthey Pharmaceutical Material West Deptford, NJ, United States [email protected]
Michael Barron Director Quality Chemical Laboratories Wilmington, NC, United States [email protected]
Michael Beckelic Manager, Quality and Regulatory Affairs Sebela Pharmaceuticals Inc. Roswell, GA, United States [email protected]
Michael Boyd Corporate Quality Assurance Auditor Procter & Gamble CIncinnati, OH, United States [email protected]
Michael Channing Radiochemist National Institutes of Health Bethesda, MD, United States [email protected]
Michael Fountoulakis Director, Quality Assurance AustarPharma, LLC Edison, NJ, United States [email protected]
Michael Megargee Senior GMP Specialist U.S. Pharmacopeial Convention Rockville, MD, United States [email protected]
Michael Ok Post-Doc University of Wuerzburg Wuerzburg, Non-US, Germany [email protected]
Michael Powanda President M/P Biomedical Consultants LLC Mill Valley, CA, United States [email protected]
Michael Schwöppe Project Manager tesa Labtec GmbH Langenfeld, Non-US, Germany [email protected]
Michele Desjardins CMO Quality Manager Galderma Baie d'rUfé, Non-US, Canada [email protected]
Michelle Espiritu Senior CRC Clinical Trial Network Houston, TX, United States [email protected]
Michelle Saylor Product Compliance Scientist USAMMDA Frederick, MD, United States [email protected]
Michelle Yorke Sr. QC Manager Biodel Inc. Danbury, CT, United States [email protected]
Miguel Mercier Deputy Director Sanofi Pasteur Toronto, Non-US, Canada [email protected]
Mike Dempsey Manager of Quality Assurance PD Pharmatech Seymour, IN, United States [email protected]
Mike Kirkbride VP Clinical American HomePatient` Tampa, FL, United States [email protected]
Mike Yelvigi Managing Partner CPI Pharma Basking Ridge,, NJ, United States [email protected]
MILAGROS HEREDIA ALFARO CATALOGATION DIGEMID LIMA, Non-US, Peru [email protected]
milton pena Pharmacist Ministry Of Health Lima, Non-US, Peru [email protected]
min chen Senior Manager, Regulatory Affairs Ultragenyx Pharmaceutical Inc. Novato, CA, United States [email protected]
Min Sik Shin Assistant Manager BCWORLD PHARM Seoul, Non-US, South Korea [email protected]
Minerva Hughes Branch Chief FDA Silver Spring, MD, United States [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information
Miriam Montante Residues Toxic Manager Laboratorio Central Regional del Norte Guadalupe, Non-US, Mexico [email protected]
Mitesh Bhadricha Consultant EY Mumbai, Non-US, India [email protected]
Mithun NM Senior Process Associate TCS Pune, Non-US, India [email protected]
Mitsu Fink Quality Control Specialist Memorial Sloan Kettering Cancer Center New York, NY, United States [email protected]
mitul patel asst manager sun vadodara, Non-US, India [email protected]
MOGALI RAMBABU Assistant General Manager-Regulatory Affairs Raks pharma Pvt. Ltd Visakhapatnam, Non-US, India [email protected] Mohamad Amiruddin Mohamad Nor
Supplier Quality Engineer Celestica (M) Sdn Bhd Johor Bahru, Non-US, Malaysia [email protected]
mohammad azad technical manager healthcare pharmaceuticals limited dhaka, Non-US, Bangladesh [email protected]
Mohammed Yousffi Quality Assurance Auditor Fresenius Kabi USA, LLC Melrose Park, IL, United States [email protected]
Mona Malhotra Senior Manager Corporate Quality Assurance Sentiss Pharma Pvt. Ltd Gurgaon, Non-US, India [email protected]
Montserrat Megías Regulatory Documentation Manager INKE, S.A. Castellbisbal, Non-US, Spain [email protected]
Na Rae Song Business Developer Dong Sung World Wide USA, Inc. Cerritos, CA, United States [email protected]
Nadia Osman Clinical trial Coordinator OSU Columbus, OH, United States [email protected]
Naga Mahendar Velishala Vice President Mirror Pharmaceuticals LLC Fairfield, NJ, United States [email protected]
Nagaraj Reddy Managing Director Ascenders Consulting Services Bangalore, KS, India [email protected]
NAGARAJ TOLNOORKAR QUALITY ASSURANCE ALLURE LABS HAYWARD, CA, United States [email protected]
NAGARJUNA BHOGADI REGULATORY AFFAIRS DAEWOONG PHARMA HYDERABAD, Non-US, India [email protected]
Naheed Sayeed Manager, Process Validation, TO Apotex Toronto, Non-US, Canada [email protected]
Nancy Feng Regulatory Affairs CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. Shijiazhuang, Non-US, China [email protected]
Nancy Lonnroth Director AMAG Derry, NH, United States [email protected]
Nancy martin Document Control Associate II Nostrum Laboratories Inc. Kansas city, MO, United States [email protected]
Nancy Muzik Associate Director, Quality Assessment Shionogi Inc. Alpharetta, GA, United States [email protected]
Nandkumar Chodankar CEO ASolution Pharmaceuticals Pvt. Ltd Mumbai, Non-US, India [email protected]
Nanduri Venkata Ramana Kumar General Manager SunPharma Industries Limited Gurgoan, Non-US, India [email protected]
Narendira Kumar Senior Manager Orchid Healthcare Chennai, Non-US, India [email protected]
Narendrasinh Gohil Quality Assurance Pharmaceutics International Inc Hunat Valley, MD, United States [email protected]
Nasrin Mehranmehr Expert Avicenna Research Institute Tehran, Non-US, Iran [email protected]
Naveen Yadav Sr. Executive Megafine Pharma (P) Limited Nashik, Non-US, India [email protected]
Nayaz Ahmed Director Quality & PD PrimaPharm.net San Diego, CA, United States [email protected]
Neel Patel Project Manager Orit Laboratories LLC West Caldwell, NJ, United States [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information
neha yadav Regulatory affairs Daewoong Pharamceutical hyderabad, Non-US, India [email protected]
NEHRU GADDIPATI CEO NINES CONSULT PHARMA NEW YORK, NY, United States [email protected]
Nestor Chihuan Farmaceutico Direccion de Medicamentos del Ministerio de Salud de Peru Lima, Non-US, Peru [email protected] Nicole Fisher
RA Manager DVC Frederick, MD, United States [email protected]
Nicole Gallo Consultant Halloran Consulting Group Boston, MA, United States [email protected]
Nicole Leonhardt Quality Specialist Dow Development Laboratories, LLC Petaluma, CA, United States [email protected]
Nicole Motley Compliance Officer Hill Dermaceuticals sanford, FL, United States [email protected]
Ninad Sheth Supervisor Taro Pharmaceutical Brampton, Non-US, Canada [email protected]
Ningpu Yu Sr Scientist Neuralstem Inc Germantown, MD, United States [email protected]
Nipun Davar Senior VP. Pharm Dev. and Mfg Threshold Pharmaceuticals South San Francisco, CA, United States [email protected]
Nirav Sevak Regulatory Affairs Specialist Nostrum Laboratories Inc kansas city, MO, United States [email protected]
Nirvi Patel qa specialist II nostrum labs kansas city, MO, United States [email protected]
Nishant sharma Regulatory and Compliance Specialist 1987 HACEKENSACK, NJ, United States [email protected]
Nishant Sharma Regulatory and Compliance Specialist Shield line LLC Hackensack, NJ, United States [email protected]
Nola Mayo Regulatory Counsel FDA Silver Spring, MD, United States [email protected]
Norma Victoria Salazar Guillen Pharmacist DIGEMID Lima, Non-US, Peru [email protected]
Nrupa Patel Research Scientist Navinta LLC Ewing, NJ, United States [email protected]
Nur Hossain pharmaceuticals Navana Pharmaceuticals limited Dhaka, Non-US, Bangladesh [email protected]
Nurjehan Jivani Corporate QA Compliance Auditor Symbio, LLC Fremont, CA, United States [email protected]
Obaid Ali Federal Inspector of Drugs Drugs Regulatory Authority of Pakistan Karachi, Non-US, Pakistan [email protected]
Olga Alfieri Assoc Director Eisai Woodcliff Lakes, NJ, United States [email protected]
Olga Alfieri` Associate Director Eisai Woodcliff Lake, NJ, United States [email protected]
Omprakash Koshti Deputy General Manager Corporate Quality SUN Phamaceutical Ltd. Vadodara, Non-US, India [email protected]
Onesmo Mpanju Principal Consulting LINQ Pharma Consulting Aldie, VA, United States [email protected]
orange zhang RA ZMC shaoxing, Non-US, China [email protected]
padmavathi rangisetty Senior Executive in Refairsgulatory Af MSN Laboratories Limited Hyderabad, Non-US, India [email protected]
Pallavi Patil Associate QA Sancilio Pharmaceutical Pvt Ltd Mumbai, Non-US, India [email protected]
Pallavi Shetty Formulation R and D Cronus research labs Pvt Ltd Bangalore, Non-US, India [email protected]
Pankaj Ingole Formulation scientist bright future , china Haikou, AL, China [email protected]
Pankaj Kashyap Regulatory Affair Akorn India Private Limited Gurgaon, Non-US, India [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information
Pankaj Patel Manager Piramal Enterprises Limited Mumbai, Non-US, India [email protected]
PARINYA SUTHEERASAK Pharmacist HIV-NAT Bangkok, Non-US, Thailand [email protected]
PASCAL WONGBI External QA Professional III Perrigo Minneapolis, MN, United States [email protected]
PASHUPATHINATH SIDDAMSHETTY MANUFACTURING CHEMIST SCIEGEN PHARMA INC HAUPPAUGE, NY, United States [email protected]
Pat Stephens President/Owner Medi-Fare Drug Blacksburg, SC, United States [email protected]
Patrice Powers-Feigel Director Tech Ops Midas Pharmaceutical, Inc. Parsippany, NJ, United States [email protected]
Patricia Amanqui Especialist evaluation of pharmaceutical product DIGEMID Lima, Non-US, Peru [email protected]
Patricia Battonyai de Oliveira Quality Operations Director Bayer HealthcCare Cleveland, TN, United States [email protected]
Patricia McDonald QA Administration Capstone Nutrition Spring Hill, TN, United States [email protected]
Patricia Mendoza Manager, Regulatory Affairs Houston Methodist Research Institute Houston, TX, United States [email protected]
Patricia Paz Regulatory Affairs Specialist GE Healthcare del Peru SAC Lima, Non-US, Peru [email protected]
Patricia Saulino Manager Medical Affairs Ascend Therapeutics Herndon, VA, United States [email protected]
Patrick Neibergall Vice President (QC/RA/DC) Weeks & Leo Co., Inc. Clive, IA, United States [email protected]
paul cleary Head of Quality EirGen Pharma Waterford, Non-US, Ireland [email protected]
Paula Costa Regulatory Affairs Analisty Prati Donaduzzi Toledo, Non-US, Brazil [email protected]
Paula Costa analist Prati Donaduzzi toledo, Non-US, Brazil [email protected]
Pavadi Subramaniam Senior Manager Quality OHM Labs Inc New Brunswick, NJ, United States [email protected]
Pawan Kumar Garg Dy. Manager Biocon Limited Bangalore, Non-US, India [email protected]
Payal Saraf Consultant EY Mumbai, MS, India [email protected]
Peddanna Gumudavelli VP QA Appco Pharma LLC Somerset, NJ, United States [email protected]
Peggy Cummings Certified Clinical Research Coordinator Lou Ruvo Center for Brain Health Las Vegas, NV, United States [email protected]
Peipei Xu Group Leader WuXi AppTec Shanghai, Non-US, China [email protected]
Peram Narayana Manager - Compliance Sun Pharmaceuticals Industries Limited Baddi, Non-US, India [email protected]
peter perfito production manager Endo Pharmaceutical rye, NY, United States [email protected]
Phanindra Singh Associate Project Manager 4C Pharma Solutions Bangalore, Non-US, India [email protected]
Philip Ashok Karunakaran President - Technical Caplin Point Laboratories Limited Chennai, Non-US, India [email protected]
phyllis sacks QA External Ops LEO Pharmaceutical Parsippany, NJ, United States [email protected]
Pierre M. Eberst Head of QA Galderma Spirig Egerkingen, Non-US, Switzerland [email protected]
Pilar Pascual Regulatory Affairs Manager TIARE CONSULTING Madrid, Non-US, Spain [email protected]
Ping Wang principal scientist JNJ Malvern, PA, United States [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information
Poonam Pande Manager Integrated CMC Solutions LLC Chapel Hill NC, NC, United States [email protected]
Postelle Birch-Smith Consumer Safety Officer FDA Silver Spring, MD, United States [email protected]
Prachi Khandelwal Manager EY Mumbai, Non-US, India [email protected]
pradeep singh Manager Drug Regulatory Affairs Ipca Laboratories Ltd. Mumbai, Non-US, India [email protected]
Prajakta Palshikar Manager - Regulatory Affairs Alpha MD Pvt Ltd Mumbai, Non-US, India [email protected]
Pranav Sarvaiya Consultant EY Mumbai, Non-US, India [email protected]
PRASANNA K BHAT Sr. Regulatory Specialist iMED Global Bangalore, Non-US, India [email protected]
Prasanna Palle Regulatory Affairs Associate Amneal Pharmaceuticals Hauppauge, NY, United States [email protected]
Prashant Vagadia Executive Sun Pharmaceutical Industries Ltd. Vadodara, Non-US, India [email protected]
Prassanjit Dey Executive Sun Pharmaceutical Industries Ltd. Vadodara, Non-US, India [email protected]
Preston Grondahl Quality Control Lead Guthy Renker Arden, NC, United States [email protected]
priyal goyal consultant Ernst and young mumbai, Non-US, India [email protected]
Puiho Yuen R&D, Product Development Dr. Reddy's Laboratories, Inc Princeton, NJ, United States [email protected]
Puja NAGPAL Post Doctoral Scientist ICGEB delhi, Non-US, India [email protected]
punit patel Sr Manager Quality Control PL Developments Westbury, NY, United States [email protected]
Purvee Patel student Temple University Philadelphia, PA, United States [email protected]
QunQun Decreny QA auditor Alliance Pharma Malvern, PA, United States [email protected]
Rachel Tan Quality system specialist Shenzhen Salubris Pharmaceuticals Co., Ltd. Shenzhen, Non-US, China [email protected] Rachelle Ware
Quality Control HP Des Moines, IA, United States [email protected]
Radha Ramesh Head of Assurance for Life Sciences, NA TCS Bridgewater, NJ, United States [email protected]
RADHIKA KONDAPAKA Medical Monitor The Emmes Corporation Rockville, MD, United States [email protected]
RAFAEL COMAS Regulatory Affairs Coordinator PROCAPS S.A. BARRANQUILLA, CO, Colombia [email protected]
Raghavendra Rao varada Asst. Manager DR. REDDYS LABORATORIES Visakhapatnam, Non-US, India [email protected]
Raghunandhan Painoori Assistant Manager Novel Laboratories, Inc. Monmouth Junction, NJ, United States [email protected]
Raghunath Chigurupati Manager HeteroUsa PISCATAWAY, NJ, United States [email protected]
raghuram pannala A.VP QA&RA Sciegen Pharmaceuticals Haupauge, NY, United States [email protected]
Ragini Mehta Medical technologist-microbiolgy NIH Bethesda, MD, United States [email protected]
RAJAN DESAI Vice President Quality OLIVE HEALTHCARE MUMBAI, Non-US, India [email protected]
Rajan Dubey Director Procurement 3tfederal solutions llc BHOPAL, Non-US, India [email protected]
Rakesh Chaurasia Head of Drug Regulatory Affairs PT DexaMedica Tangerang, Non-US, Indonesia [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information
Rakesh Lad Vice President AptaPharma Inc Pennsauken, NJ, United States [email protected]
ramakrishna sampathi Regulatory Affairs Consultant Benta Pharma Industries Beirut, Non-US, Lebanon [email protected]
Rambabu Mogali Assistant.General Manager-Regulatory Affairs Rakspharma.com visakhapatnam, Non-US, India [email protected] Rambabu Mogali
Assist.General Manager-Regulatory Affairs Raks Pharma Pvt. Ltd Visakhapatnam, Non-US, India [email protected]
Ramireddy chityala In-process Quality Assurence caplin point laboratories ltd chennai, Non-US, India [email protected]
Ramon Genoves Quality manager Celestica Valencia Valencia, Non-US, Spain [email protected]
Ranjana Arote Sr. Manager Regulatory Affairs Enaltec Labs Private Limited Thane, Non-US, India [email protected]
Raquel Otero Graubard Quality Assurance & Regulatory Director Amino Cell, Inc. Fort Lauderdale, FL, United States [email protected]
Ratna Lingamaneni Director, Regulatory Affairs AbbVie North Chicago, IL, United States [email protected]
Raul Gonzales Global Quality Manager Celestica New York, NY, United States [email protected]
Ravi Chhatani Manager Actavis Mumbai, Non-US, India [email protected]
Ravi Sankar Kothamasu Manager - Intellectual Property Suven Life Sciences Limited Hyderabad, Non-US, India [email protected]
Ravi Srikanth Tallapragada Manager - QA Mirror Pharmaceuticals Fairfield, NJ, United States [email protected]
Ravishankar Vadali Associate Director Janssen R&D Springhouse, PA, United States [email protected]
rebecca cuniff Senior Regulatory Affairs First Priority, Inc. Elgin, IL, United States [email protected]
Rebekah Wood Chemist United therapeutics Silver spring, DC, United States [email protected]
Reddy kal Director, Quality Systems Fresenius Medical Care Ogden, UT, United States [email protected]
Renae Dixon Assoc Director of Regulatory Affairs CPI Fishers, IN, United States [email protected]
Renate Eggert QA Biotest Dreieich, Non-US, Germany [email protected]
Rene Flores VP Operations DGF Group San Juan, Non-US, Puerto Rico [email protected]
Renita Johnson-Leva Director ABL Rockville, MD, United States [email protected]
renu gupta Principal Global Bio-Pharma Consulting Moorestown, NJ, United States [email protected]
Renuka Yanamadala Asst. Manager Granules india limited Hyderabad, Non-US, India [email protected]
Rhonda Jones President Scientific & Regulatory Consultants, Inc. Columbia City, IN, United States [email protected]
Richard Reeve Sr. Director R&D Quality Assurance Endo Malvern, PA, United States [email protected]
rikinkumar gandhi Superviosr Quality Yichang Humanwell OSD Plant Yichang, Non-US, China [email protected]
Rita George Quality Control Manager KP Pharmaceutical Technology Inc. Bloomington, IN, United States [email protected]
Ritesh Panjabi Quality Assurance officer Glenmark Pharmaceuticals Limited Mumabi, Non-US, India [email protected]
Ritesh Panjabi Officer-Quality Assurance Glenmark Pharmaceuticals Ltd Mumbai, Non-US, India [email protected]
Robbie Scott Quality Coordinator Kenco Logistics Chattanooga, TN, United States [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information
Robert Bard Managing Director HTC LLC Northville, MI, United States [email protected]
Robert Eackles Product Compliance Scientist CRM Frederick, MD, United States [email protected]
Robert Garcia QA Director Hill Dermaceuticals, Inc. Sanford, FL, United States [email protected]
Robert Hauser Executive Vice President Perosphere Inc Danbury, CT, United States [email protected]
Robert Iser Senior Scientific Advisor (acting) FDA/CDER/OPQ/OPF Silver Spring, MD, United States [email protected]
Robert Kaster President RK Pharmaceutical Consulting LLC Glenmoore, PA, United States [email protected]
Robert Melo President OHM pharma inc Mineral Wells, TX, United States [email protected]
Robert Melo President OHM PHARMA INC Mineral Wells, TX, United States [email protected]
Robert Wolfangel VP Scientific Affairs Certus International Inc St. Louis, MO, United States [email protected]
Roberto Toledo VP Sales & Marketing DGF Group San Juan, Non-US, Puerto Rico [email protected]
Rock Chen Regulatory Director Easton Pharmaceuticals Chengdu, Non-US, China [email protected]
Rolando Vega sanitary authorizations - evaluator MINSA - PERÚ Lima, Non-US, Peru [email protected]
Rong Pan regulatory affairs specialist Austarpharma LLC Edison, NJ, United States [email protected]
Roohi Obaid Deputy Drugs Controller Drug Regulatory Authority of Pakistan KARACHI, Non-US, Pakistan [email protected]
Rosa Guzman Consultant DGF Group San Juan, Non-US, Puerto Rico [email protected]
Rosa Lugo Compliance Consultant DGF Group San Juan, Non-US, Puerto Rico [email protected]
Rosa Rivera INSPECTOR MINISTRY OF HEALTH OF PERU LIMA, Non-US, Peru [email protected]
Rosanna Fajar Senior Research Worker John Hopkins University/Columbia University New York, NY, United States [email protected] Rosario Luis
Inspector DIGEMID Lima, Non-US, Peru [email protected]
Rose Zhao Managing Director Emprise Pharma LLC Phoenixville, PA, United States [email protected]
Roshni Patel QA Supervisor Supernus Pharmaceuticals Rockville, MD, United States [email protected]
Ross Velasquez Quimico Farmaceutico Direccion General de Medicamentos Insumos y Drogas Lima, Non-US, Peru [email protected]
Rowen Luna Senior Quality Engineer Fresenius Kabi USA Melrose Park, IL, United States [email protected]
Roxanne Sisak Quality Assurance Manager J Knipper and Company, Inc. Lakewood, NJ, United States [email protected]
Roy R Fennimore Jr Principal Engineer Johnson & Johnson Raritan, NJ, United States [email protected]
Ruchi Sahgal Sr. QA, Analytical Astex Pharmaceuticals Pleasanton, CA, United States [email protected]
Ruchi Sahgal Sr. QA, Analytical Astex Pharmaceuticals Pleasanton, CA, United States [email protected]
ruhul amin Sr.QA Manager Ad-din pharma Ltd Jessore, Non-US, Bangladesh [email protected]
russbelt aliaga Technical director Genzyme Lima, Non-US, Peru [email protected]
Russell Fortney Team Leader FDA Silver Spring, MD, United States [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information
Ruth Aquino QA Manager Specialty Silicone Fabricators, Inc. Tustin, CA, United States [email protected]
Ryan McCarthy QA/QC Technician Xttrium Laboratories Mount Prospect, IL, United States [email protected]
S BALAJI Deputy Manager QA Caplin point Laboratories Limited Chennai, Non-US, India [email protected]
Saadia Alam QC Analyst (Validation Coordinator) pfizer pharmaceuticals Karchi, Non-US, Pakistan [email protected]
Sabrina Mon Biotechnologist Medistem Panama Inc. Panama, Non-US, Panama [email protected]
Sachinkumar Patel Chemist US FDA White oak, MD, United States [email protected]
Sai Patkar Research Assistant Bionanotechnology Laboratory Philadelphia, PA, United States [email protected]
Sai Patkar Graduate Research Assistant Drexel University Philadelphia, PA, United States [email protected]
Sailaja Chirravuri Regulatory Affairs Officer Mylan Bangalore, Non-US, India [email protected]
Sailaja Machiraju Research Associate ParagonBioteck Portland, OR, United States [email protected]
Sally Berry Chief Medical Officer Tris Pharma Monmouth Junction, NJ, United States [email protected]
Sam Venugopal Partner PwC San Jose, CA, United States [email protected]
Samantha Bouldin Director of Quality Control Advanced Breath Diagnostics Brentwood, TN, United States [email protected]
Samantha Kaltenbach Quality Assurance Specialist ISTO Technologies, Inc. St. Louis, MO, United States [email protected]
Samia Nasr Pharmacologist FDA Silver Spring, MD, United States [email protected]
Sampath Ayyappa Quality Assurance Appcure labs Hyderabad, Non-US, India [email protected]
sandeep uppaluri Sr. QA Compliance Specialist Fresenius Kabi USA schaumburg, IL, United States [email protected]
Sandra Garrido President TopFire, LLC Plano, TX, United States [email protected]
Sanjay Thorat Sr. Executive Genpact-Pharmalink Mumbai, Non-US, India [email protected]
sanjivani kulkarni sr. Manager JBChemicals and pharmaceuticals mumbai, Non-US, India [email protected]
sankalp sontakke Internal audit Dr. Reddys laboratories ltd hyderabad, Non-US, India [email protected]
Sanket Patel QA Human Biosciences Gaitherburg, MD, United States [email protected]
Sanobar Parkar Director AlphaMD Pvt Ltd Mumbai, Non-US, India [email protected]
Santhosh Manupati Drug safety Associate Ascenders Consulting Services Bangalore, KS, India [email protected]
SANTOSH NARLA Manager Regulatory Affairs Laurus Labs private limited Hyderabad, Non-US, India [email protected]
Sara Ethier Senior QA Manager Haemtech Biopharma Services Essex Junction, VT, United States [email protected]
Sara Xiao Manager, Regulatory and Supply Chain Hisun Pharmaceuticals USA., Inc Princeton, NJ, United States [email protected]
Sarah Kennedy Document Control Assoicate I Nostrum Labs Kansas City, MO, United States [email protected]
Sarah Serrano Corporate Director Quality Control PL Developments Miami, FL, United States [email protected]
SATISH CHAVA Manager Dr.Reddy's Laboratories Ltd Hyderabad, Non-US, India [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information
Savitha Rani Assistant Manager - Regulatory Affairs Orchid Healthcare Chennai, Non-US, India [email protected]
Scott Murrin Vice President of Quality Capstone Nutrition Ogden, UT, United States [email protected]
season Sun Regulatory Department Yiling Pharmaceutical, Inc. Vegas, NV, United States [email protected]
SEEMA GEETHA GOPAL Supervisor Quality Assurance Apotex Inc Richmond Hill, Non-US, Canada [email protected]
Seema Joshi Manager Sun Pharma Gurgaon, Non-US, India [email protected]
Sena Dissmeyer Sr. QA Associate Pharmaceutics International, Inc. Hunt Valley, MD, United States [email protected]
Seok Seo Sr. QA Manager Paramount Cosmetics Clifton, NJ, United States [email protected]
Seoung Yong Lee Counselor Embassy of Republic of Korea Washington DC, DC, United States [email protected]
sereta muse CONSULTANT QMASC(SC), INC. IRMO, SC, United States [email protected]
Seth Kreger Product Development Manager Cook MyoSite Pittsburgh, PA, United States [email protected]
Shahper Rahman Regulatory Manager Reckitt Benckiser Parsippany, NJ, United States [email protected]
Shalender Pratap Singh Quality management system Alkem laboratories Limited Badii, Non-US, India [email protected]
Shane Bailey Regulatory Affairs Virtus Pharmaceuticals Tampa, FL, United States [email protected]
Shanmuka Harish Chalamuri QA Specialist II Nostrum Laboratories Kansas City, MO, United States [email protected]
Sharad Kholambe Executive Sun Pharmaceutical Industries Limited Mumbai, Non-US, India [email protected]
Shariq Mehmood Regularly Affairs Executive Pharmevo private limited Karachi, Non-US, Pakistan [email protected]
Sharon Maliar Executive consultant PQE Tel Aviv, Non-US, Israel [email protected]
sharon Roberts Pharmacist ECI Pharmaceuticals Fort Lauderdale, FL, United States [email protected]
Shelley Mendenhall Senior Director, Regulatory and QA Inotek Pharmaceuticals Corporation Lexington, MA, United States [email protected]
shelly fehr IND/IDE Director UPenn philadelphia, PA, United States [email protected]
Shelly Shirkey Supervisor, Regulatory Affairs Boehringer Ingelheim Chemicals,Inc. Richmond, VA, United States [email protected]
sheree mcgill Manager- QA, ESH, Regulatory PHT International, Inc. Charlotte, NC, United States [email protected]
sherry elchin director of operations osiris therapeutics, inc collumbia, MD, United States [email protected]
Shi Qijun project manager chnmed Beijing, Non-US, China [email protected]
Shirish Shah CSO, Development and Regulatory EZRA Pharma LLC Phoenix, AZ, United States [email protected]
shirley shi Executive VP eVenuspharma Princeton, NJ, United States [email protected]
Shuli Cui Regulatory Intern Cerulean Pharma Boston, MA, United States [email protected]
shweta singh Executive iMEDGlobal solution Pvt.Ltd Bangalore, KS, India [email protected]
Siba Bhattacharyya Chemist CDER/FDA Silver Spring, MD, United States [email protected]
Sidharth Puri Manufacturing Johnson & Johnson Baddi, Non-US, India [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information
Silsymar Inácio Quality Auditor Prati-Donaduzzi Toledo, Non-US, Brazil [email protected]
Silvane Guzzi project manager Prati Donaduzzi &Cia Ltda Toledo, Non-US, Brazil [email protected]
sneha inamdar Associate Apotex miami, FL, United States [email protected]
SNIGDHA BEZAWADA Regulatory Operations Manager CCS Associates San Jose, CA, United States [email protected]
Socorro Mogul Sr Director PAR PHARMACEUTICAL INC Chestnut Ridge, NY, United States [email protected]
Sohyun Suk Regulatory Affairs Associate Celltrion Pharm Ochang, Non-US, South Korea [email protected]
Sonia Haley Regulatory Consultant Halloran consulting group Richmond, VA, United States [email protected]
Sophia Finckbone Manufacturing Supervisor ISTO Technologies, Inc. Saint Louis, MO, United States [email protected]
Sophy Abraham Head of Regulatory Affairs Elite Laboratories Inc. Northvale, NJ, United States [email protected]
SOUSSAN SHAZAND QUALITY ASSURANCE MANAGER PHARMASCIENCE MONTREAL, Non-US, Canada [email protected]
Sri Polina Regulatory Affairs Specialist PuraCap Pharmaceutical LLC South Plainfield, NJ, United States [email protected]
sri krishna chaitanya jammalamadaka Senior Executive Caplin Point Laboratories Ltd Chennai, Non-US, India [email protected]
Srinivas Peruri Marketing Manager Mylan Laboratories Limited Hyderabad, Non-US, India [email protected]
srinivas Yandrapu Manager DQA Dr.Reddys Labs Princeton, NJ, United States [email protected]
Sriramam Rayasam BS Duke Pharmacy Durham, NC, United States [email protected]
SRIRAMAM RAYASAM BS DUKE PHARMACY COMPOUNDING FACILITY DURHAM, NC, United States [email protected]
srivalli bontha assistant manager xellia pharmaceuticals bangalore, Non-US, India [email protected]
Stefan Geanta QA Manager Impopharma Inc. Concord, Non-US, Canada [email protected]
Stephan Chang Director Daewoong America Inc. Rockville, MD, United States [email protected]
Stephan Chang PhD Daewoong America Inc. Rockville, MD, United States [email protected]
stephane charland Suplier Certification mgr Pharmascience Montreal, Non-US, Canada [email protected]
Stephanie Petaway-HIckson Regulatory / Compliance Manager Calibration Technologies Morris Plains, NJ, United States [email protected]
Stephen Tucker Manager of Product Development Cutanea Life Sciences Wayne, PA, United States [email protected]
Steve Miller Dir. Quality and Regulatory Affiars Air Liquide Healthcare America Houston, TX, United States [email protected]
steve griffith VP - Business Development formpipe Red Bank, NJ, United States [email protected]
Steve Hong CEO BCWORLD PHARM Seoul, Non-US, South Korea [email protected]
Steve Huang RAS NIH Rockville, MD, United States [email protected]
Steven Goldner Director Quality Assurance Klus Pharma Monmouth Junction, NJ, United States [email protected]
Steven Thomas Senior counsel GSK Raleigh, NC, United States [email protected]
Subramanian Iyer Vice President Mylan Laboratories Limited Hyderabad, Non-US, India [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information
Sudhakar Bandari President Aurex Laboratories East Windsor, NJ, United States [email protected]
Sue Gifaldi Senior Manager, Compliance Janssen Pharmaceuticals Holley, NY, United States [email protected]
Sue Wang Manager, Technical Consultant ITRI ROCKVILLE, MD, United States [email protected]
Suhas katare Regulatory Affairs RRPL Mumbai, Non-US, India [email protected]
Sumeet Parwe RA Sunstar Americas, Inc. Elgin, IL, United States [email protected]
sungil ko RA manager seegene seoul, Non-US, South Korea [email protected]
Sunil Dahiya Regulatory Scientist Kinapse Life Sciences Gurgaon, Non-US, India [email protected]
SUNIL KUMAR Asst Manager Sentiss Pharma private ltd GURGAON, Non-US, India [email protected]
Suresh Anaganti cGMP auditor Amneal Pharmaceuticals New york, NY, United States [email protected]
Suresh Kumar Chennaparapu Sr.Manager-Regulatory affairs Raks pharma Pvt. Ltd visakhapatnam, Non-US, India [email protected]
suresh kumar periyasamy Microbiologist caplin point laboratories ltd chennai, TN, India [email protected]
suresh vujjini Sr Manager kashiv pharma Bridgewater, NJ, United States [email protected]
surya patra Research Analyst Phillip Capital India pvt Ltd Mumbai, Non-US, India [email protected]
susan zavala EVALUATOR (DRUG REGISTRATION TEAM) DIGEMID LIMA, Non-US, Peru [email protected]
susan fasso CEO Global Pharma GxP consulting cherry Hill, NJ, United States [email protected]
Susan Horth QA Manager Endo Pharmaceutical Rye, NY, United States [email protected]
Susan Ocon Quality Control Genentech-Roche Vacaville, CA, United States [email protected]
Susan Todd Senior Manager, Regulatory Affairs West-Ward Pharmaceutical Corp Eatontown, NJ, United States [email protected]
Suzana Marusic President Hooke Laboratories, Inc. Lawrence, MA, United States [email protected]
Swathi Etikala RA Executive Sarvotham Care Secunderabad, Non-US, India [email protected]
syed saleem Chief Compliance Officer Apothecary health grand prairie, TX, United States [email protected]
Tab Dobbins QC Senior Supervisor Guthy-Renker Arden, NC, United States [email protected]
Tae-Hyun Park RA staff Celltrion Pharm Cheong-Ju, Non-US, South Korea [email protected]
Talpaneni Joseph Sunder Raj Group Analytical Manager Dexa Medica Jakarta, Non-US, Indonesia [email protected]
Tamara Clark Branch Chief FDA Silver Spring, MD, United States [email protected]
Tamra Sami Editor-in-Chief, Quality & Enforcement FDAnews Falls Church, VA, United States [email protected]
Tania Galcik RA Specialist DynPort Vaccine Company Frederick, MD, United States [email protected]
Tania Galcik RA Specialist DynPort Vaccine Company Frederick, MD, United States [email protected]
Tania Martinez Regulatory Director Demos Global Group, Inc Miami, FL, United States [email protected]
TANIA OVIEDO Inspector - Specialist Dirección General de Medicamentos, Insumos y Drogas Lima, Non-US, Peru [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information
Tara Nath Quality Assurence Caplin point labs ltd., Chennai, TN, India [email protected]
Tara Norouzi QA NIH Bethesda, MD, United States [email protected]
tatiana short auditor prati-donaduzzi toledo, Non-US, Brazil [email protected]
Teresa Bales Compliance Specialist Focus CVS Knoxville, TN, United States [email protected]
Teresa Hernandez Supervisor Bayer Orizaba, Non-US, Mexico [email protected]
Teresa Tung President Alpha Pharma Services LLC Lake Success, NY, United States [email protected]
Terrie Foster Quality Assurance Document Control Hewlett Packard Des Moines, IA, United States [email protected]
Tetyana Denyssevych quality management officer BC Cancer Agency vancouver, Non-US, Canada [email protected]
Tetyana Dusaniwskyj Regulatory Affairs Project Manager Osiris Therapeutics Inc. Columbia, MD, United States [email protected]
Thanhhoa Nguyen Scientist Amgen Thousand Oaks, CA, United States [email protected]
Thomas Berkheimer Quality Assurance Manager Barton Solvents, Inc. Des Moines, IA, United States [email protected]
Thomas Busmann Manager, Process Engineering Focus Compliance and Validation Services Knoxville, TN, United States [email protected]
Thomas Ingallinera VP Pii Hunt Valley, MD, United States [email protected]
Threshold Andersen Senior Process Chemist Threshold Pharmaceuticals South San Francisco, CA, United States [email protected]
thrilok p Jr. Executive Caplin Point Laboratories Limited Chennai, Non-US, India [email protected]
Thuy Nguyen Consumer Safety Officer FDA Silver Spring, MD, United States [email protected]
Ti Wang Regulatroy Affairs Manager Jiangsu Hansoh Lianyungang, Non-US, China [email protected]
Tim Ames VP, Global Strategic Regulatory Affairs Mylan, Inc. Washington, DC, United States [email protected]
Tina G Qiu Ophthalmic Executive Consultant/Principal Directional Healthcare Advisors LLC Peabody, MA, United States [email protected]
Tina Sanford QA Specialist ImmunoScience, Inc. Dublin, CA, United States [email protected]
Tina Tong Health Specialist NIH Rockville, MD, United States [email protected]
TJ Higley VP Powdersize Inc Quakertown, PA, United States [email protected]
TJ Jacobs Director, IT Global Regulatory Compliance Celestica Inc. Toronto, Non-US, Canada [email protected]
Todd Lumbert Site Head of Quality SPI Pharma Grand Haven, MI, United States [email protected]
Todd Sunstrom Director QA ARx Glen Rock, PA, United States [email protected]
Tom Bolton Associate Director Regulatory Affairs CMC Nektar Therapeutics Huntsville, AL, United States [email protected]
Tom Huang Manager Klus Pharma Inc Monmouth Junction, NJ, United States [email protected]
Tomaso Dameno Pharma GMDP Compliance Director PQE Suisse Locarno, Non-US, Switzerland [email protected]
Tonika Waugh Quality Assurance Associate ImmunoScience Pleasanton, CA, United States [email protected]
Tooba Murshedkar Associate Director, Regulatory Affairs Sanaria Inc. Rockville, MD, United States [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information
Towana Elmore Quality Assurance Manager Convenience Valet Melrose Park, IL, United States [email protected]
Travis Bemiss Nuclear Pharmasist Precision Nuclear Gey, TN, United States [email protected]
TRVV Subramanyam Assistant Manager Rakspharma Pvt. Ltd. Visakhapatnam, Non-US, India [email protected]
TRVV Subramanyam Assistant Manager-Regulatory Affairs Raks Pharma Pvt. Ltd. Visakhapatnam, Non-US, India [email protected]
Uday Kompella CSO Ocugen, Inc. Aurora, CO, United States [email protected]
Udayaraj Kadri Head - Quality Assurance Caplin Point Laboratories Ltd. Chennai, Non-US, India [email protected]
uri shpolansky CTO physiological models pardes hanna carcur, Non-US, Israel [email protected]
Utkarsh Jaiswal Assistant Manager Quality Assurance Dr Reddy's Lab Hyderabad, Non-US, India [email protected]
Valeri Sewald Client Relations Coda Corp USA Westfield, NJ, United States [email protected]
Valerie Ahmuty Sr. Director, Regulatory Affairs TherapeuticsMD Boca Raton, FL, United States [email protected]
Vamshidhar Pillarishetty RA Project Manager Amneal Pharmaceuticals Piscataway, NJ, United States [email protected]
Veeraswamy Cherukuri Manager-QA Lupin Ltd., Mumbai, Non-US, India [email protected]
VEERENDRA NANJWADE RESERACH EXECUTIVE UNICHEM LABS Panjim, GA, India [email protected]
Venkat Ramana Krishna Chunduru Dy.Manager-QA Raks Pharma Visakapatnam, AL, India [email protected]
VENKAT REDDY SUNKARA Manager - Regulatory Affairs Aesica Pharmaceuticals Ltd Cramlington, Non-US, United Kingdom [email protected]
venkata varanasi Regulatory Associate riconpharma LLC Denville, NJ, United States [email protected]
venkatesh alla Sr. Associate Mylan Laboratories Limited Bangalore, Non-US, India [email protected]
Venkatreddy Kumbam Senior scientist ScieGen pharmaceuticals Inc Hauppauge, NY, United States [email protected]
Veronique St-Hilaire Quality Projects Specialist Galderma Baie D'Urfé, Non-US, Canada [email protected]
VIBHAKAR SHAH Consumer Safety Officer USFDA Silver Spring, MD, United States [email protected]
Victor Paulus Head, Regulatory Affairs Advanced Accelerator Applications USA New York, NY, United States [email protected]
Victoria Scott Associate Director Quality and Regulatory Hemispherx Biopharma, Inc. New Brunswick, NJ, United States [email protected]
vijay kanani Regulatory Affairs - Executive Zydus cadila Vadodara, Non-US, India [email protected]
Vijayakumar Balasubramanian Senior Manager Harman Finochem Limited Aurangabad, Non-US, India [email protected]
Vijayanand Chakrapani General Manager WOCKHARDT LIMITED Aurangabad, Non-US, India [email protected]
Vilas Malge Assistant Grade I Regulatory Affairs Sun Pharmaceutical Industries Limited Vadodara, Non-US, India [email protected]
Vilma Naupari Evaluator DIGEMID Lima, Non-US, Peru [email protected]
Vinay Bhatt VP, Quality and R.A. Leading Pharma,LLC Fairfield, NJ, United States [email protected]
Vinayak Pawar Senior Review Microbiologist Food & Drug Administration Silver Spring, MD, United States [email protected]
Vincent Li Chemist FDA Silver Spring, VA, United States [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information
Vini Patel RA Associate Bio-Pharm Inc. Levittown, PA, United States [email protected]
Vinicius Beal Boufleur Analyst Prati Donaduzzi Toledo, Non-US, Brazil [email protected]
Vinod Mandowara Manager-Business Development Sentiss pharma Gurgaon, Non-US, India [email protected]
Vipin Vasanthakumar Manager - Regulatory Affairs Orchid Healthcare Chennai, Non-US, India [email protected]
virendra khanapure Project Managment APC Pharmaceuticals and Chemicals Mumbai, Non-US, India [email protected]
Vishal Oza Regulatory Affairs Sun Pharmaceutical Industries Limited Vadodara, Non-US, India [email protected]
vishal patel Sr. Regulatory Affairs Teva Pharmaceuticals Horsham, PA, United States [email protected]
Vishal Singh Assisstant General Manager Inventia Healthcare Private Limited Mumbai, MA, India [email protected]
Viswesh Achanta Executive Daewoong Pharmaceutical Co Ltd Hyderabad, Non-US, India [email protected]
Vivian An RA CSPC Pharmaceutical (Shijiazhuang)Co.,Ltd Shijiazhuang, Non-US, China [email protected]
Wai Yu Regulatory Affairs Supervisor Carlsbad Technology, Inc. Carlsbad, CA, United States [email protected]
Walter Jump President Cornerstone Regulatory LLC Langhorne, PA, United States [email protected]
Wanda Hernandez Project Manager TherapeuticsMD Boca Raton, FL, United States [email protected]
Warren Crumplin Regulatory Affairs Chemist Fine Chemicals Corporation Cape Town, Non-US, South Africa [email protected]
Wei Zhang Vice President, QA/QC Youngtech Pharmaceuticals, Inc. Cranbury, NJ, United States [email protected]
Weifeng Ji Associate Director Relypsa, Inc Redwood city, CA, United States [email protected]
weiwei hua PM HPC Bethsda, MD, United States [email protected]
weiwei hua PM HPC Edison, NJ, United States [email protected]
Wendy Galbraith Pharmacist University of Oklahoma Oklahoma City, OK, United States [email protected]
Wendy Linthicum Product Compliance Scientist USAMMDA Frederick, MD, United States [email protected]
Wendy Sanhai Senior managing Scientist Exponent Inc Alexandria, VA, United States [email protected]
wendy tan Microbiologist FDA Rockville, MD, United States [email protected]
wendy whitfield Regulatory / Compliance Officer Piramal Healthcare UK Limited Morpeth, Non-US, United Kingdom [email protected]
Whitney Dollins Quality Specialist Apothecares Decatur, AL, United States [email protected]
Whitney Dollins Quality Assurance Specialist Apothecares/ Southern Compounding Decatur, AL, United States [email protected]
wilfredo Pimentel Del Valle pharmaceutical chemist E.B. Pareja Lecaros S.A Lima, ME, Peru [email protected]
Willaine Costa Researcher Prati,Donaduzzi e Cia Ltda Toledo, Non-US, Brazil [email protected]
William Kwok Associate Director, RA BD Rx. Inc Franklin Lakes, NJ, United States [email protected]
William Tubbs Director Regulatory Affairs and Quality Assurance Promedior Lexington, MA, United States [email protected]
William Turok President and General Counsel Corporate Pharma, Ltd. Jersey City, NJ, United States [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information
William Turok President and General Counsel Corporate Pharma Jersey City, NJ, United States [email protected]
William Washington Director QA Rhodes Pharmaceuticals Coventry, RI, United States [email protected]
Willian Tapia Tapia Ramírez Consultor de Catalogación DIGEMID (Dirección General de medicamentos Insumos y Drogas) - Perú Lima, Non-US, Peru [email protected] wu can
regulatory affairs CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. shijiazhuang, Non-US, China [email protected]
Xia Yang assistant Jiangsu Hansoh Pharmaceutical Co., Ltd. princeton, NJ, China [email protected]
xian wu Regulatory affairs specialist Jiangsu Hansoh Lianyungang, Non-US, China [email protected]
Xiaohong Zhang regulatory affair eastonpharma chengdu, Non-US, China [email protected]
xiaoli ma QA Furen Hetero Onco therapeutics Ltd. Zhengzhou, Non-US, China [email protected]
Xiong Lu Registration manager chnmed Beijing, Non-US, China [email protected]
Xiumei Ruan Chemist FDA Silver Spring, MD, United States [email protected]
xuan zhang regulatory specialist Daewoong Beijing, Non-US, China [email protected]
Y Wang Director Purdue Stamford, CT, United States [email protected]
yahya el-kattan VP CMC BioCryst Pharmaceuticals Birmingham, AL, United States [email protected]
Yanhong Qi QC Manager CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. Shijiazhuang, Non-US, China [email protected]
Yanira Gonzalez-Berrios Chemist FDA Silver Spring, MD, United States [email protected]
Yanira Gonzalez-Berrios Chemist FDA Silver Spring, MD, United States [email protected]
Yaolin Wang Regulatory Specialist Hengrui Pharm Shanghai, Non-US, China [email protected]
Yarery Smith Microbiologist FDA Silver Spring, MD, United States [email protected]
Yaseen Momin Manager Regulatory Affairs Genpharma El Jadida, Non-US, Morocco [email protected]
Yasuyuki Shimoura QA specifalist Sysmex America Inc. Lincolnshire, IL, United States [email protected]
Ye Zhang Reviewer FDA Silver Spring, MD, United States [email protected]
Yen Nguyen Sr RA Associate Sandoz princeton, NJ, United States [email protected]
Yesmil Pena Consultant Consultant Woodbridge, Non-US, Canada [email protected]
Yinka Green Consultant Independent Waltham, MA, United States [email protected]
Yolma Gonzalez Staff Scientist SHL pharma Deerfield Beach., FL, United States [email protected]
Yonghong Yang Manager Kashiv Pharma LLC Bridgewater, NJ, United States [email protected]
Yongli Lin Regulator affairs manager Zhejinag Starry Pharmaceutical Co., Ltd. Xianju, Non-US, China [email protected]
York Tomita Science Adv FDA Silver Spring, MD, United States [email protected]
YSABEL SONIA GUTIERREZ AURES PHARMACYST DIGEMID LIMA, Non-US, Peru [email protected]
YU XUE International certification LUYE PHARMA YANTAI, Non-US, China [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information
Zahid Muhammad Director Quality Assurance Pii Towson, PA, United States [email protected]
Zhengpin Guan Quality Director Sichuan Qingmu Pharmaceutical Co., Ltd. Chengdu, Non-US, China [email protected]
zhi chen Manager of regulatory affairs Prinston Pharmaceutical Inc. cranbury, NJ, United States [email protected]
Zichun Liu International registration Waterstone(Hubei) Pharmaceutical Co.Ltd Wu han, Non-US, China [email protected]
Zulfiqar Choudary QA/RA Manager JABIL Circuits Inc Auburn Hill, MI, United States [email protected]
Zuo Sophia QA manager Zjpharma.Inc. Shijiazhuang, Non-US, China [email protected]
青 郎 RA CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd Shijiazhuang, Non-US, China [email protected]