KEY BENEFITS FOR 2017: • Discuss the challenges involved with microbial control with

Takeda • Following the path to effi cient sterility assurance with GSK • Bimeda highlight the importance of environmental modelling • Delve into the latest developments in rapid microbial

methods with Janssen • Hear the latest on data integrity and compliance with Roche

SMi present the 7th in its series...

Hyatt Regency Mission Bay, San Diego, USA

Pharmaceutical Microbiology USA

Addressing the current challenges in sterility assurance, environmental monitoring and RMM whilst evaluating the latest trends and opportunities for microbial control.

WORKSHOPS: 7THCONFERENCE:

8TH - 9TH

JUNE 2017

REGISTER BY 28TH FEBRUARY AND SAVE $300REGISTER BY 31ST MARCH AND SAVE $200REGISTER BY 28TH APRIL AND SAVE $100

www.pharma-microbiology-usa.com Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711

ACADEMIC & GROUP DISCOUNTS AVAILABLE @SMIPHARM#smimicrobiology

PLUS TWO INTERACTIVE HALF-DAY PRE-CONFERENCE WORKSHOPSWednesday 7th June 2017, Hyatt Regency Mission Bay, San Diego, USA

Technologies for Monitoring Contamination Control and Case Studies on Contamination Control

08.30 – 12.30 Workshop Leaders:

Jim Polarine Jr, Senior Technical Service Manager, STERIS Corporation Andrew Bartko, Research Leader, Battelle Memorial Institute

Microbial Required Use for Terminal Sterilization

13.30 – 17.30 Workshop Leader:

Jerry Dalfours, Principal, JD Technologies

Sponsored by

CHAIRS FOR 2017: • Donald Singer, GSK Fellow, Steriles Microbiology, R&D, GSK • John Duguid, Senior Director, Research & Development,

Vericel Corporation

EXPERT SPEAKER PANEL INCLUDE: • Ron Smith, Director, External Supply Integration Quality, Janssen • Ren-Yo Forng, Scientifi c Director, Amgen • Kevin Luongo, QC Sr. Scientist (Microbiology), Takeda • Lina Orjuela, Microbiologist, Merck • Paul Ricciatti, Sterility Assurance Manager, Bimeda • Jeanne Moldenhauer, Vice President,

Excellent Pharma Consulting • Akua Gilbert-Arthur, Principal Scientist,

Roche Molecular Systems

Pharmaceutical Microbiology USA Day One | Thursday 8th June 2017 www.pharma-microbiology-usa.com

08.30 Registration & Coffee

09.00 Chairman’s Opening Remarks Donald Singer, GSK Fellow, Steriles Microbiology, R&D, GSK

OPENING ADDRESS 09.10 Retracing the path to sterility assurance: An USP journey • Update on latest revisions of USP microbiology chapters • Discussion of work activities for revising chapter on sterility

assurance • Current thinking about sterile product evaluation topics

(bacterial endotoxins testing, alternative pyrogen test, container closure integrity evaluation, sterility test)

Donald Singer, GSK Fellow, Steriles Microbiology, R&D, GSK

ENVIRONMENTAL MONITORING

09.50 The importance of environmental monitoring • Environmental monitoring in today’s pharmaceutical

industry is imperative to avoid potential risks to consumers and to save time and cost to manufacturers

• Rules governing dispersion of airborne microbial contaminants and how contaminants can accumulate in invisible vortices and airborne contamination

• How to evaluate representative sampling locations for environmental monitoring during aseptic processes

Paul Ricciatti, Sterility Assurance Manager, Bimeda 10.30 Morning Coffee

11.00 Environmental monitoring trend analysis tools • The importance of proper analysis and evaluation of

viable EM results. • Development of a “tool box” in order to produce

specialized data reports. • A case study in using the correct tools to demonstrate

environmental control in a cleanroom environment Steve Walton, Technical Manager, Sterility Assurance,

Sanofi

11.40 Gram negative LPS structural alterations in response to environmental stimuli

• Overview of how gram negative bacteria adapt to various environmental conditions

• The role of modulation of outer membrane components has on facilitating environmental adaptation

• The effect of external stimuli and structural adaptation has on the classical LPS architecture

John Dubczak, Director of Operations, Charles River

12.20 Networking Lunch

CHALLENGES IN ENDOTOXIN RECOVERY & STERILITY ASSURANCE

13.20 Challenges in endotoxin testing • Advantages of in-process control • Issues occurring in the detection of endotoxins • Utilising the alternative endotoxin reagents and/or

methods to detect potential contaminants in products Ren-Yo Forng, Scientifi c Director, Amgen

14.00 Interactive extended training session: Effects of cleanrooms and barrier systems on environmental monitoring data

Recent warning letters show that manufacturers of aseptic products are receiving the most 483s; many are related to smoke studies. Smoke / Airfl ow Visualization tests are often performed by third party certifi ers. However, per FDA guidance, dynamic in-situ air pattern analysis is more complex. These studies should be investigative and effective at identifying design fl aws or airfl ow issues. They should be performed using the correct type of smoke, smoke density, and camera angles.

• A closer look at existing regulation (e.g. Pharm. Eur., USP, PDA)

• Why do we need to implement rapid microbial methods vs classical microbial methods?

• How to evaluate the best RMM for each application • Validation strategy, regulatory strategy and examples

of return of experiences Morgan Polen, Subject Matter Expert on Contamination

Control, Microrite

15.00 Afternoon Tea

15.30 Bringing the cleanroom online after an adverse event • Environmental control of classifi ed areas within a

biopharmaceutical facility - maintained by systems controlling humidity, air temperature, air exchanges, fi ltration and pressure differentials

• When any of these systems or practices fail, it’s considered a “Worst Case Event” which has the potential to impact the clean state of a Classifi ed Area

• FDA Warning Letters and 483s will be covered that focus on cleanroom shut down and start up procedures

Jeanne Moldenhauer, Vice President, Excellent Pharma Consulting

16.10 Microbiological examination of non-sterile products • Experience with USP <61> and USP <62> tests • Utilising these test to provide harmonization with the

European Pharmacopeia methods • Challenges incurred and lessons learnt Elizabeth Hulanick, Microbiologist, Renaissance

Pharmaceuticals

16.50 Chairman’s Closing Remarks and Close of Day One

Sponsored by

Register online at www.pharma-microbiology-usa.com

SPONSORSHIP AND EXHIBITION OPPORTUNITIESSMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company’s marketing strategy. Prime networking

opportunities exist to entertain, enhance and expand your client base within the context of an independent discussion specifi c to your industry. Should you wish to join the increasing number of companies benefi ting from sponsoring our conferences please call: Alia Malick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk

Charles RiverProtecting the integrity of your products requires a reliable partner at all critical junctures in the QC process. We’ve purposely built our portfolio to bring you progressive products and services that deliver accurate, relevant and reliable data to fuel confi dent decisions on product quality and contamination control. Our unique combination of Endosafe® endotoxin testing, Celsis® rapid microbial detection and Accugenix® microbial identifi cation and strain typing keeps your manufacturing operations running effi ciently and smoothly, lowers your cost to manufacture and protects your reputation. www.criver.com/products-services/manufacturing-support

Rapid Micro Biosystems delivers the Growth Direct™ System, an automated, non-destructive rapid detection and enumeration technology based on the compendial method for microbial quality control in pharmaceutical manufacturing. The system automates and accelerates detection and enumeration in the areas of environmental monitoring, bioburden and sterility testing eliminating manual steps and analysis. The Company’s Growth DirectTM System detects contamination earlier, delivering compelling economic benefi ts to manufacturers, while improving their quality process. The Growth Direct System is the fi rst and only automated system that addresses all key microbial QC applications and fi ts with current regulatory practices, a critical accelerator for adoption. Automated analysis eliminates error-prone manual steps and saves labor; rapidly detecting contamination enables manufacturers to reduce inventory carrying costs, shorten manufacturing cycle time, and reduce product losses, delivering signifi cant cost savings and increased operational effi ciency. www.rapidmicrobio.com

Pharmaceutical Microbiology USAwww.pharma-microbiology-usa.com Day Two | Friday 9th June 2017

08.30 Registration & Coffee

09.00 Chairman’s Opening Remarks John Duguid, Senior Director, Research & Development,

Vericel Corporation

RAPID MICROBIAL METHODS

OPENING ADDRESS 09.10 Challenges involved with microbial control • A CMO-focused microbial control strategy • The challenges with managing an external

manufacturing program • Looking to the future Kevin Luongo, QC Sr. Scientist (Microbiology), Takeda

09.50 Validation of a Rapid Microbial Method: Case studies for microbial limits and sterility testing.

• Overview of the approach for testing equivalence of a qualitative method

• Demonstrating equivalence to pour plate method for Microbial Limits testing of betamethosone suspension

• Demonstrating equivalence to membrane fi ltration sterility test method for a saline product

Ronald Smith, Director, External Supply Integration Quality, Janssen

10.30 Morning Coffee

11.00 US approval of three rapid microbiological methods for MACI product release

• Same day product release is needed for MACI® (autologous cultured chondrocytes on porcine collagen membrane)

• Automated rapid microbiological methods enable test results within hours

• Regulatory requirements are continuing to evolve John Duguid, Senior Director, Research & Development

Vericel Corporation

DATA INTEGRITY

11.40 Data integrity and compliance • Current limitations with data integrity • How to improve the reliability of data is necessary

to support clinical trials, product development and manufacturing, and testing and reporting requirements

• Examining data integrity in relation to related to pharmaceutical microbiology, including environmental monitoring and laboratory analysis

Akua Gilbert-Arthur, Principal Scientist, Roche Molecular Systems

12.20 Networking Lunch

13.20 Lessons learned in microbial data integrity management • Data integrity within analytical and microbiology

laboratories for all phases of the drug product lifecycle • What works well? How can it be improved? • Examining the recently released draft guidance data

integrity and compliance with CGMP guidance for industry Lina Orjuela, Microbiologist, Merck

BIOFILMS & OTHER CONTAMINANTS

14.00 Additional background on biofi lm, its impacts in healthcare, her discovery, and current testing.

• We are losing the war on bacteria. One of the reasons is biofi lm -- the sticky substance that bacteria form in order to attach to surfaces and then shield the developing colony from environmental stresses

• It is no coincidence that every bacterium on the lists of the Center for Disease Control are biofi lm-formers: urgent threats (C. diff, etc.), pandemic threats (pneumonia, T.B., E.coli, Salmonella, Listeria, cholera, plague, etc.), bioterror threats (anthrax, etc.),, and antimicrobial-resistant strains (MRSA, MDR-TB, CRES, etc.)

• As biofi lm builds it captures other bacteria, and there is evidence of horizontal gene transfer between different species

• There are few remedies for biofi lm. Scraping and sterilization work, but they are short term. Biofi lm was recorded on a titanium plate within 30 seconds after sterilization

• The human immune system, biocides and antibiotics are designed to kill free-fl oating bacteria. Nothing known can remove pre-formed biofi lm at non-lethal doses

Cynthia Burzell, Founder & CSO, Aequor, Inc.

14.40 Afternoon Tea

15.10 Challenges with contamination issues • Mold - A simple method to eliminate and prevent mold

anywhere. • Biofi lm - Simple and fast methods to eliminate and

prevent biofi lm • Spores - Simple ways to eliminate quickly and safe for

your equipment/surfaces Brian Hubka, CEO, BGH International, LLC

15.50 Common errors in microbial identifi cation and implications • Phenotypic vs. Genotypic systems-capabilities and

defi ciencies • Defi cient media quality control • Microbiology laboratory training defi ciencies that lead

to errors • Growth media and incubation errors • Gram staining errors • What to do when in doubt • Case studies Ziva Abraham, CEO, Microrite

16.30 Chairman’s Closing Remarks and Close of Day Two

Register online at www.pharma-microbiology-usa.com Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711

MARKETING OPPORTUNITIESWant to know how you can get involved? Interested in promoting your services to this market?

Contact Zoe Gale, SMi Marketing on +44 (0) 207 827 6132 or email: zgale@smi-online.co.uk

Supported byOffi cial Media Partners:

Overview of the workshop:This session will discuss pathways to use the data obtained from environmental monitoring to provide proactive and practical solutions for comprehending and managing everyday pharmaceutical microbiology challenges. This presentation will cover case studies on human fl ora and spore contamination in cleanroom operations. The workshop will cover the most common causes of contamination: operators, items brought into the cleanroom, and degradation of the cleanroom over time. Case studies in operator borne contamination will be discussed as well as preventative long term solutions. Targeted long term solutions will be discussed regarding the spore case studies in a concerted effort to limit reoccurrences. The overall objective and scope of this seminar will be to discuss specifi c cases studies that have occurred in my years of experience in the industry. The concepts of cleaning and disinfection, application frequency, disinfectant rotation, and rinsing and residue removal strategies will be covered as well.

Why should you attend this workshop:This industry workshop will give attendees valuable insight into the world of contamination control and troubleshooting fungal and bacterial spore excursions in cleanrooms. Attendees will gain new insight into common causes of CAPA investigations which will cut down on time that is invested fi nding potential causes for contamination which can cost an organization 50K per investigation.

Programme

08.30 Registration & Coffee

09.00 Opening remarks & introductions

09.15 Introduction • Conventional methods • Limitations

09.45 Sensing fundamentals • Absorption and fl uorescence • Vibrational and Raman spectroscopy • Mass spectrometry

10.30 Morning Coffee

11.00 Utilisation of spectrometric methods • Advantages and limitations of new methods • Comparisons to traditional microbial quality control

11.30 Industry case studies • Vegetative organisms • Fungal spores • Bacterial spores

12.15 Interactive exercise

12.30 End of workshop

About the Workshop Leaders:Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for sixteen years. His current technical focus is microbial control in cleanrooms and other

critical environments. He is active as co-chair on the PDA’s microbial investigations task force. He was a co-author on PDA’s Technical Report #70 on Cleaning and Disinfection. He is a member of the PDA’s Environmental Monitoring Group, Contamination Control Group, and Biotech Interest Group.

Dr. Andrew P. Bartko received a B.S. from the University of Pittsburgh in 1997 and a Ph.D. in physical chemistry in 2002. Dr. Bartko is a senior scientist in Battelle’s Technology Development Group where

he contributes to several applied spectroscopy efforts that focus on biological and chemical sensing. Dr. Bartko is the manager and technical leader of an interdisciplinary team that is developing Battelle’s Resource Effective Bioidentifi cation System (REBS).

About the Organisation:STERIS is a global leader in infection prevention, contamination control, surgical and critical care technologies,

and more. STERIS is the world’s pre-eminent infection prevention, decontamination, and surgical and critical care company. Every day, the people of Battelle apply science and technology to solving what matters most. At major technology centers and national laboratories around the world, Battelle conducts research and development, designs and manufactures products, and delivers critical services for government and commercial customers.

Technologies for Monitoring Contamination Control and Case Studies

on Contamination Control

Workshop Leaders: Jim Polarine Jr, Senior Technical Service Manager, STERIS Corporation and Andrew Bartko,

Research Leader, Battelle Memorial Institute

HALF-DAY PRE-CONFERENCE WORKSHOPWednesday 7th June 2017

08.30 – 12.30Hyatt Regency, Mission Bay, San Diego, CA

Overview of the workshop:Determining best way to work with Microorganisms to ensure we have sterilization that verifi es we have no patient risk or product stability issues due to survival of the microorganism or damage to the product due to sterilization.

Why should you attend this workshop:Knowing how to most effectively establish your D-values, Z-values, F-values and Fbio-values along with Fo, FH and lethality based on your bioburdens and any biological indicator you select to use in your process based on the variables associated with so many different issues associated with different products that all need to be proven to be sterile prior to distribution.

Programme

13.30 Registration & Coffee

14.00 PNSU – BIOBURDEN – Probability Function D values, Z values and Fo

• How were those established? • Where Did “Fo” start relative the microbial

impact • Microbiological D value variations • Can’t typically use what the vendor provides for

D values and Z values based on your product trying to be sterilized.

• Typical BI Death Curve and Fraction Negative • D121 value, Z value and Determination of Fo • Bioburden Monitoring and determination of

potential sterilization risk compared to any biological indicator

15.30 Afternoon Tea

16.00 Recent FDA Sterilization Observations Resulting in Warning Letters – Providing what the FDA has written about a variety of different situations that has caused signifi cant concerns based on many companies not having the correct perspective about Microbiological Sterilization.

17.20 Closing remarks

17.30 End of workshop

About the Workshop Leader:Mr. Jerry Dalfors has extensive (40+ years) of business administration, consultative, technical and managerial experience in the development and manufacture of highly regulated

biopharmaceutical products including injectables, biologics, medical devices and oral dosages. He has held permanent employee, temporary employee and company representative management positions with a multitude of the major pharmaceutical and biotechnology companies in the US. He has worked with or assisted more than two dozen companies with the establishment of controlled document/quality systems, FDA briefi ng and submittal documents, project management of several multimillion dollar projects including design, start-up and validation to assure fast track FDA approval by maintaining strict regulatory compliance during all phases of engineering, construction, commissioning and validation, and has written numerous submission documents for product, process and facility approval/licensing which also required the development of quality systems which included customer complaint management, deviation management, CAPA and associated site wide employee training. Each of his projects have been received and accepted by the FDA and other regulatory agencies. Jerry is considered and expert in most all aspects of the biopharmaceutical and medical device industry and has trained many FDA fi eld inspectors on a variety of topics. None of his work has ever received a 483 but has corrected and prevented many along with Warning Letter remediation.

About the Organisation:JD Technologies provides consulting, regulatory and documentation support to the pharmaceutical and biopharmaceutical industries. JD Technologies prides itself on being able to succesfully carry a project from concept to completion, and integrating with other company employees and contractors in a team effort.

Microbial Required Use for Terminal Sterilization

Workshop Leader:Jerry Dalfours, Principal, JD Technologies

HALF-DAY PRE-CONFERENCE WORKSHOPWednesday 7th June 2017

13.30 – 17.30Hyatt Regency, Mission Bay, San Diego, CA

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VENUE Hyatt Regency, Mission Bay, San Diego, CA, USA

PHARMACEUTICAL MICROBIOLOGY USA Conference: Thursday 8th & Friday 9th June 2017, Hyatt Regency, Mission Bay, San Diego, CA, USA Workshop: Wednesday 7th June 2017, San Diego, CA, USA

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