hybrid event validation week

Proven Strategies to Achieve Regulatory Compliance, Ensure Quality and Leverage Advanced Tools and Technologies

INFORMACONNECT.COM/VALWEEK

PRESENTED AS A VIRTUAL EVENT • October 26-28, 2021

Validation WeekHYBRID EVENT

EVENT AGENDA VIRTUAL EXPERIENCE

3 Full Days of Recorded Content – Plenaries, Workshops and Session Tracks

Dynamic Event Platform Features Including:

— Attendee and Company Profiles

— Advanced Search Capabilities to Identify Opportunities and Potential Partners

— Easy-to-Use Technology to Enable Virtual Networking

— Seamless Scheduling Tools to Establish Meeting Times

PLUS — Access to the ON-DEMAND LIBRARY for 30-days post-conference

VIRTUAL EVENT — OCTOBER 26-28, 2021 Benefit from three days of content including live presentations, virtual networking,

and an On-Demand library.

DAY ONE — OCTOBER 26, 2021 All times are listed in EDT8:30 – 8:45 Chairperson’s Welcome & Opening Remarks

Ghada Haddad, Ph.D., Executive Director, Global cGMP Compliance and Auditing Organization, Merck & Co.Elise Wyatt, Conference Producer, Informa Connect-IVT

8:50 – 9:50 5th Annual Diversity, Equity and Inclusion Summit CONVERSATION CONTRIBUTORS:Roberta Goode, Ph.D., Professor, Miami UniversityKelly Simpliciano, M.S., Associate Director, Audits & Inspections, Global Quality – Clinical Trials Systems & Auditing QA, Bristol Myers Squibb Karyn Campbell, Senior Director, QA Audit and Compliance, Abbvie

9:55 – 10:55 Medical Devices: Examining the Parallels between Process Validation and Design VerificationRoberta Goode, Professor, Miami University

10:55 – 11:25 Take Time for Virtual Networking — Visit Booths and Networking Tables

11:25 – 12:25 Integrate Risk Into Change ControlAlan Golden, Principal, Design Quality Consultants

12:25 – 1:25 Take Time for Virtual Networking

Industry-Only Solution Summit Hosted by:

Get Smart With Your Data: 3 Things to Bring Intelligence Into Everything You DoFerdi Steinmann, Senior Global Industry Strategist, Life Sciences, OpenText

1:25 – 2:10 IVT Awards Ceremony

2:15 – 3:15 FDA Highlight Kimberly A. Trautman, MS., Former Executive Vice President Medical Device International Services, NSF Medical Devices

3:15 Close of Day 1

DAY TWO — OCTOBER 27, 2021 All times are listed in EDT

8:30 – 8:45 Day 2 Kick OffGhada Haddad, Ph.D., Executive Director, Global cGMP Compliance and Auditing Organization, Merck & Co.

8:50 – 9:50 Data Integrity and Integrating AutomationKaren Ginsbury, B.Pharm., M.Sc., President and CE, PCI Pharmaceutical Consulting Israel Ltd.

9:55 – 10:40

Knowledge as the Currency of Managing Risk – Advancing the Connectivity Between KM and QRM as Dual PQS EnablersMarty Lipa, Executive Director, Knowledge Management, Merck

10:40 – 11:10 Take Time for Virtual Networking — Visit Booths and Networking Tables11:10 – 11:55 Eliminate Inefficiencies of Paper-Based Qualifications & Maintenance Activities

Rick Mineo ,Director of Strategic Partnerships, KneatJustin Blackwelder , Manager, Project Services, PCI

11:55 – 12:55 Take Time for Virtual Networking — Visit Booths and Networking Tables12:55 – 1:55 CHOOSE YOUR TRACK (1-2)

1. REGULATORY FOCUS 2. TOOLS AND TECHNOLOGIESBring Your Own Inspection Readiness ChallengeKaryn Campbell, Senior Director, QA Audit and Compliance, Abbvie

Development and Validation of Analytical Methods for Combination Products Kurt Moyer, Ph.D., President, Pine Lake Laboratories

1:55 – 2:55 Take Time for Virtual Networking

2:25 – 3:25 CHOOSE YOUR TRACK (1-2)

1. REGULATORY FOCUS 2. TOOLS AND TECHNOLOGIESImpact of COVID-19 on Inspection ManagementKelly Simpliciano, M.S., Associate Director, Audits & Inspections, Global Quality – Clinical Trials Systems & Auditing QA, Bristol Myers Squibb

Annex 1 Contamination Control – What the Recent Revision Means for ValidationParsa Famili, President & CEO, Novatek International

3:25 Close of Day 2

DAY THREE — OCTOBER 28, 2021 All times are listed in EDT8:30 – 8:45 Day 3 Kick Off

Ghada Haddad, Ph.D., Executive Director, Global cGMP Compliance and Auditing Organization, Merck & Co.

8:50 – 9:35 Software Assurance and Quality — A Practical ApproachValarie King-Bailey, M.B.A., Chief Executive Officer, Onshore Technology Group

9:40 – 10:40 Validation Statistics for Non-Statisticians Alan Golden, Principal, Design Quality Consultants


11:10 – 11:55 Facility Commissioning & Equipment QualificationMauricio Chinchilla Romero, Staff Quality Engineer, Edwards Lifesciences

12:00 – 12:45 Accelerate Digitalization in Pharma with Low Code PlatformsManne V. Chowdary, M.D., CEO, AmpleLogic


1:45 – 2:45 CHOOSE YOUR TRACK (1-2)

1. REGULATORY FOCUS 2. TOOLS AND TECHNOLOGIESQuality Management Systems and Continuous ManufacturingBayan Takizawa, MD MBA, Chief Business Officer, Continuus Pharmaceuticals, Inc.

Cleaning Validation: A Decade of TransformationRizwan Sharnez, Founder & President, Cleaning Validation Solutions

2:45 – 3:15 Take Time for Virtual Networking — Visit Booths and Networking Tables3:15 – 4:15 CHOOSE YOUR TRACK (1-2)

1. REGULATORY FOCUS 2. TOOLS AND TECHNOLOGIESMastering Regulatory ComplianceAlberto Viciedo, Director, Global Auditing EU/ME Team, Global cGMP & Compliance Auditing Organization, Merck & Co., Inc.

Evaluating SaaS SystemsSamuel Cheemakoti, GMP Head, IT Systems for OTC Drugs, Beiersdorf

4:15 Close of Conference

VIRTUAL EVENT — OCTOBER 26-28, 2021 (CONTINUED)



Cleaning Validation 101Paul L. Pluta, Ph.D., Editor-in-Chief, Journal of Validation Technology and Journal of GXP Compliance, IVT Network

Digitize and Accelerate ValidationSpeaker TBD, Valgenesis

Strategies and Techniques for Process ValidationIgor Gorski, Former Associate Director, Takeda

Develop Effective Strategies for Managing the Validation Quality SystemKaren Ginsbury, B.Pharm., M.Sc., President and CE, PCI Pharmaceutical

GMP Facility and Process Design & EngineeringIgor Gorski, Former Associate Director, Takeda

Designing a 21 CFR 11 Compliant SpreadsheetClark Davies, ASQ CSQE, Sr. Software Quality Engineer, Abbott Nutrition

Content Highlight Presented by Alcon LaboratoriesConnie Hetzler, Global Head of Validation, Manufacturing Science & Technology, Alcon Laboratories

CONFERENCE SPONSORS:Validation Solutions

ON-DEMAND SESSIONS:

A GREAT PLACE TO MEET YOUR MARKET

Maximize your access to decision-makers and align your brand with the life sciences industry’s premier thought-leaders and industry innovators. Informa Connect’s custom sponsorship programs are designed to support your organization’s overall business development and marketing initiatives through meaningful prospect and customer interactions, brand assertion campaigns and content-rich thought-leadership opportunities. Capitalize on the life sciences community’s premier platform for peer-to-peer exchange, solution driven content and first-in-class networking opportunities. For more information on how to position your company as a sponsor or exhibitor, contact Steven Markos at +1 978-580-9288 or email at [email protected].

hybrid event validation week

Documents