13th Annual PDA Global Conference on Pharmaceutical Microbiology

pda.org/2018Micro

13th Annual PDA Global Conference on Pharmaceutical Microbiology Portions of this Conference will be simulcast with the PDA Europe Pharmaceutical Microbiology Conference

The Future of Pharmaceutical Microbiology: Small World, Big Opportunities

October 15-17, 2018 | Bethesda, MD Exhibition: October 15-16

2018 PDA Endotoxins Workshop: October 17-18

CONNECTING

#PDAMICRO

Courses: October 18-19

REGULATION

This Agenda is current as of July 18, 2018 RECORDINGS ARE PROHIBITED AT ALL PDA EVENTS

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13TH ANNUAL PDA GLOBAL CONFERENCE ON PHARMACEUTICAL MICROBIOLOGY – GENERAL INFORMATION

Connecting People, Science and Regulation®

PROGRAM PLANNING COMMITTEE

A MESSAGE FROM THE PROGRAM CO-CHAIRS Dear Colleagues:

Program Co-Chairs: Kim Sobien PETNET Solutions | A Siemens Company Amy McDaniel, PhD FDA

Ebony Arrington, MS Pfizer Inc. Julie Barlasov-Brown, MBA Merck & Co., Inc.

Kim Sobien – Co-Chair PETNET Solutions | A Siemens Company

Amy McDaniel, PhD – Co-Chair FDA

On behalf of the Program Planning Committee, we are pleased to extend a personal invitation to you to attend the 13th Annual PDA Global Conference on Pharmaceutical Microbiology, October 15-17 at the Bethesda North Marriott Hotel & Conference Center. We have created an exceptional agenda highlighting the future of pharmaceutical microbiology.

Industry experts will provide inspiring and thought-provoking presentations around our theme of “The Future of Pharmaceutical Microbiology: Small World, Big Opportunities,” converging on the continuing changes and challenges of global pharmaceutical manufacturing as the industry grows and moves forward.

Renée Blosser FDA

Through presentations and case studies, attendees will hear how others have solved highly complex problems and developed novel, compliant, and robust solutions to ensure products are of the highest quality for patients.

Yeissa M. Chabrier-Roselló, PhD FDA

This year, the 13th Annual PDA Global Conference on Pharmaceutical Microbiology will join forces with the PDA Europe Pharmaceutical Microbiology Conference, presenting a new and exciting feature of sharing content by simulcasting presentations from each Conference. This collaboration will bring a truly global aspect to the conference and enhance the agenda by providing viewpoints on pharmaceutical microbiology from the USA and Europe.

Bo Chi FDA Ashley M. Durusky Biogen Irving Ford Celgene Christine Sherman Takeda Edward Tidswell, PhD Merck & Co., Inc. Radhakrishna S. Tirumalai, PhD US Pharmacopeial Convention MaryEllen E. Usarzewicz, MS Bristol-Myers Squibb Eric J. Ward, MBA Boston Analytical Josh Eaton PDA Molly O’Neill Moir, CMP PDA

The conference will kick off with an exciting look into the world of chimeric antigen receptor (CAR) T cell therapy. In subsequent sessions, you will hear case studies from industry experts about overcoming current challenges and preparing for future manufacturing obstacles. Regulatory experts will share knowledge about the complexities involved in ensuring that product regulation regarding microbiology is clear, consistent, and predictable. Concurrent sessions will cover biotech products, risk assessment and mitigation, and environmental monitoring.

Fresh perspectives and case studies demonstrating the use of teamwork to solve microbiology mysteries will be presented in the always inspiring “Emerging Leaders” session. The Conference will conclude with the ever-popular and always intriguing “Ask the Regulators” panel discussion, where the audience can interact with regulatory experts to get answers to their most pressing microbial questions.

Take advantage of networking opportunities during the lunch breaks and networking events, and don’t miss the Exhibit Hall filled with vendors showcasing new technologies and trends for pharmaceutical microbiology strategies, and posters highlighting the latest research.

This year’s program will connect industry, academic, and regulatory professionals at all levels to achieve a unified goal of preparing for the future through sharing of best practices, development of standards, and integration of innovative technologies.

You will have the unique opportunity to contribute to future advancements in pharmaceutical microbiology through your participation. Please join us October 15-17, 2018 in Bethesda, MD for this unique and interactive learning opportunity!

Sincerely,

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Co-chairs, 13th Annual PDA Global Conference on Pharmaceutical Microbiology Program Planning Committee

GENERAL INFORMATION For specific information on the 2018 PDA Endotoxins Workshop, turn to page 12.

REGISTER NOW

Online: pda.org/2018Micro Fax: +1 (301) 986-1093 Questions? Please call +1 (301) 656-5900 ext. 115

VENUE

Bethesda North Marriott Hotel & Conference Center 5701 Marinelli Rd North Bethesda, MD 20852 Phone: +1 (301) 822-9200 Website: https://book.passkey.com/event/49551780/ owner/2644099/home Rate: Single/Double: $269, plus applicable taxes Cut-off Date: Monday, September 17, 2018. A PDA block of rooms is available on a first-come first-served basis and must be secured by the cut-off date to receive the PDA rate. After the cut-off date, rooms will be available at the prevailing rate based on availability.

CONTINUING EDUCATION CREDITS PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms, and email the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive CPE credit.

ALERT: ACPE and the National Association of Boards of Pharmacy developed the Continuing Pharmacy Education (CPE) Monitor that allows pharmacists to electronically track their CPE credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE accredited activity. Always submit CPE activity claims as soon as possible and by the deadline specified on the CPE credit request form.

13th Annual PDA Global Conference on Pharmaceutical Microbiology ACPE # 0116-0000-18-021-L04-P | 1.625 CEUs Type of Activity: Knowledge

LEARNING OBJECTIVES At the completion of this Conference, participants will be able to: • Explain topics such as managing microbial risk and dynamics of microbial contamination • Identify current and future trends in microbiology • Implement appropriate microbial control strategies

• Examine the challenges with risk assessment/mitigation • Interpret local regulatory and pharmacopeial expectations • Discuss global aspects of microbiology and aseptic processing (Annex 1) • Summarize best practices for utilizing EM data to control processes

WHO SHOULD ATTEND VPs | Directors | Heads | Managers | Senior Scientists | Professionals with intermediate to advanced knowledge and experience in the following: Biotechnology | Bioanalytics | Biomanufacturing | Biopharmaceuticals | Bioprocessing | Biosimilars | Biotherapeutics | Cell Line | Clinical Immunology | Development | Commercial Biologics | Drug Safety & Risk Management | Expression Systems | Immunogenicity Testing | Market Entry | Partnering and Licensing | Patient Safety | Product Development | Protein Characterization | Scale-up Processes | Quality Assurance | Regulatory Affairs | Regulatory CMC

CONFERENCE REGISTRATION HOURS

Sunday, October 14: 3:00 p.m. – 7:00 p.m.

Monday, October 15: 7:00 a.m. – 5:45 p.m.

Tuesday, October 16: 7:00 a.m. – 5:30 p.m.

Wednesday, October 17: 7:00 a.m. – 12:15 p.m.

COURSE REGISTRATION HOURS

Thursday, October 18: 7:30 a.m. – 4:00 p.m.

Friday, October 19: 7:30 a.m. – 4:00 p.m.

DRESS/ATTIRE Business casual attire is recommended for all events. Since the temperature in meeting rooms tends to be cool, please bring a jacket or sweater for your comfort.

SPECIAL REQUIREMENTS If you require special accommodations to fully participate, please attach a written description of your needs with your registration form. Specific questions can be directed to registration@pda.org.

CONTACT INFORMATION Conference Inquiries Molly O’Neill Moir, CMP, Vice President, Programs & Meetings Tel: +1(301) 656-5900 ext. 132 | Email: moir@pda.org Registration Customer Care Tel: +1 (301) 656-5900 ext. 115 | Email: registration@pda.org Exhibition/Sponsorship Inquiries David Hall, Vice President, Sales Tel: +1 (240) 688-4405 | Email: hall@pda.org Education Course Series Inquiries Stephanie Ko, Senior Manager, Lecture Education Tel: +1 (301) 656-5900 ext. 151 | Email: ko@pda.org

13TH ANNUAL PDA GLOBAL CONFERENCE ON PHARMACEUTICAL MICROBIOLOGY – GENERAL INFORMATION

13th Annual PDA Global Conference on Pharmaceutical Microbiology The Future of Pharmaceutical Microbiology: Small World, Big Opportunities October 15-17, 2018 | Bethesda, MD Exhibition: October 15-16 #PDAMICRO

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13TH ANNUAL PDA GLOBAL CONFERENCE ON PHARMACEUTICAL MICROBIOLOGY – AGENDA

Connecting People, Science and Regulation®

SUNDAY, OCTOBER 14 – MONDAY, OCTOBER 15 SUNDAY, OCTOBER 14 3:00 p.m. – 7:00 p.m.

Registration Open

MONDAY, OCTOBER 15 7:00 a.m. – 5:45 p.m.

Registration Open 7:00 a.m. – 8:00 a.m.

Continental Breakfast 8:00 a.m. – 9:45 a.m.

P1: The New Frontier of Personalized Medicine: Regulatory Expectations and Microbiological Challenges Moderator: Kim Sobien, Principal Sterility Assurance Engineer, PETNET Solutions | A Siemens Company Imagine using your own body’s cells to cure cancer – the idea has recently been made tangible and has been shown to be successful with new discoveries in the field of immuno-oncology. CAR T (Chimeric Antigen Receptor T-Cell) therapy is a novel, cellular therapy that supercharges a patient’s own immune system T-cells and programs them to attack designated cancer cells in the body. Significant challenges with facility design, room classification, manufacturing, testing, and regulatory approval have been brought forth as several of these personalized “living drug” therapies have achieved commercialization. This opening plenary session will explore CAR T product manufacturing challenges from an industry perspective and discuss regulatory challenges for commercialization and the use of non-compendial microbiology methods.

8:00 a.m. – 8:15 a.m.

Welcome and Opening Remarks from Conference Co-Chair Kim Sobien, Principal Sterility Assurance Engineer, PETNET Solutions | A Siemens Company 8:15 a.m. – 8:45 a.m.

Industry Perspective on CAR T Commercialization Yoko Momonoi, Director, Regulatory CMC, Celgene 8:45 a.m. – 9:15 a.m.

Regulatory Perspective on CAR T Commercialization Kimberly L. Schultz, Biologist, CBER, FDA (Invited) 9:15 a.m. – 9:45 a.m.

Questions and Answers/Discussion 9:45 a.m. – 10:15 a.m.

Refreshment Break

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LIVE SIMULCAST BETWEEN BETHESDA, MD AND BERLIN, GERMANY

MONDAY, OCTOBER 15 (CONTINUED) 10:15 a.m. – 11:45 a.m.

P2: Current Regulations in EU and US EU Moderator: Michael J. Miller, PhD, President, Microbiology Consultants, LLC US Moderator: Julie Barlasov-Brown, MBA, Associate Director Sterile and Microbiology QA, Merck & Co., Inc. 10:15 a.m. – 10:45 a.m.

Microbiological Implications of the Annex 1 Revision Andrew Hopkins, Senior GMDP Inspector, Medicines and Healthcare Products Regulatory Agency (MHRA) 10:45 a.m. – 11:15 a.m.

Common Inspection Trends Justin A. Boyd, Investigator, ORA, FDA

LIVE SIMULCAST BETWEEN BETHESDA, MD AND BERLIN, GERMANY

11:15 a.m. – 11:45 a.m.

Questions and Answers/Discussion 11:45 a.m. – 1:30 p.m.

Grand Opening of Exhibit Hall with Lunch and Poster Presentations 11:45 a.m. – 7:00 p.m.

Exhibit Hall Open

EXHIBITION AND SPONSORSHIP OPPORTUNITIES The 13th Annual PDA Global Conference on Pharmaceutical Microbiology offers exciting and unique sponsorship and exhibition packages designed to strengthen brand image, increase visibility, and help you connect with industry leaders. This Conference will bring together VPs, directors, department heads, managers, and senior scientists from biopharmaceuticals, bioprocessing, clinical immunology, product development, scaleup, quality assurance, and regulatory departments.

13TH ANNUAL PDA GLOBAL CONFERENCE ON PHARMACEUTICAL MICROBIOLOGY – AGENDA

13th Annual PDA Global Conference on Pharmaceutical Microbiology The Future of Pharmaceutical Microbiology: Small World, Big Opportunities October 15-17, 2018 | Bethesda, MD Exhibition: October 15-16 #PDAMICRO

Good foot traffic is one thing; good leads are another. At this Conference, you will have access to attendees from a variety of manufacturing companies – making this a must-attend meeting. In addition, high-profile sponsorships are available for lanyards, notepads, audience response systems, tote bags, pens, refreshment breaks, lunch, and the Networking Reception. We’ll create a customized sponsorship package to fit your needs and budget.

For more information about exhibit and sponsorship opportunities, please contact: David Hall, Vice President, Sales | Tel: +1 (240) 688-4405 | Email: hall@pda.org

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13TH ANNUAL PDA GLOBAL CONFERENCE ON PHARMACEUTICAL MICROBIOLOGY – AGENDA

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Connecting People, Science and Regulation®

MONDAY, OCTOBER 15 (CONTINUED) 1:30 p.m. – 3:30 p.m.

A1: The Trouble with Sterility Moderator: Edward Tidswell, PhD, Executive Director, Microbiology QA, Merck & Co., Inc.

1:30 p.m. – 3:30 p.m.

B1: Novel Products, Methods, and Manufacturing Processes Moderator: Irving Ford, Head of CAR-T QC Laboratories, Celgene

Sterility is an absolute and binary concept – we categorize therapeutics either sterile or non-sterile. Yet the modality of imparting sterility, sterile manufacturing, and the method of proving sterility remain challenging and possibly one of the greatest potential risks to patient safety. Regulatory expectations, compliance observations, and the cadre of contemporary microbiological tools all used to assure sterility will be discussed to provide a picture of how to avoid trouble with sterility.

The challenges raised by new products, test methods, and manufacturing processes present great opportunities for innovative approaches in microbiology. The introduction of these new elements is changing how we think of microbiology, and forcing the industry and regulators to look at new approaches for process control and product release. This session will explore a novel process, test method, and product to provide unique insights into how the future is quickly becoming the present.

1:30 p.m. – 2:00 p.m.

Avoiding Regulatory Trouble with Sterility: Drug Product Sterilization Stephen E. Langille, PhD, Acting Division Director, Division of Microbiology Assessment, CDER, FDA

1:30 p.m. – 2:00 p.m.

Process Development and Manufacturing: Current and Future Challenges Vienna Lo, Principal Scientist, Novartis

2:00 p.m. – 2:30 p.m.

The Problem with Sterility: Aseptic Processing, the Things We Don’t Talk About (Enough) Hal Baseman, Chief Operating Officer, ValSource LLC 2:30 p.m. – 3:00 p.m.

Industry Perspective on Sterilization Industry Representative Invited 3:00 p.m. – 3:30 p.m.

Questions and Answers/Discussion

2:00 p.m. – 2:30 p.m.

The Monocyte Activation Test (MAT) for Pyrogen Detection Devon Kleindienst, MS, Research Scientist II, BristolMyers Squibb 2:30 p.m. – 3:00 p.m.

Microbiological Considerations for Drug Products Derived from Cannabis and Cannabis Components Marla Stevens-Riley, PhD, Quality Assessment Lead (Acting)/Master Microbiology Reviewer, CDER, FDA 3:00 p.m. – 3:30 p.m.

Questions and Answers/Discussion

3:30 p.m. – 4:15 p.m.

Refreshment Break and Poster Presentations in Exhibit Hall 4:15 p.m. – 5:45 p.m.

A2: Microbial Control Moderator: Eric J. Ward, MBA, Director of Quality Assurance, Boston Analytical

4:15 p.m. – 5:45 p.m.

B2: Small Mold: Big Problem! Case Studies on Mold in a Manufacturing Facility Moderator: Ebony Arrington, MS, Pfizer Global Supply, Production Operations, Central Support Manager, Pfizer Biotech

The external environment to a manufacturing process presents a significant source of microorganisms.

The potential for microbial ingress from the external environment poses a great challenge for microbial control.

This session will focus on controlling a process “from the outside in,” through case studies on equipment contributions and use of EM data to protect a process prior

In the wide diversity of the microbial world, mold represents a relatively small portion of the possible overall contaminants. However, the presence of mold within a pharmaceutical manufacturing facility creates the need for heightened awareness and response commensurate with the risk that it poses to the process and ultimately the patient. In this session, two case studies will be presented

MONDAY, OCTOBER 15 (CONTINUED) – TUESDAY, OCTOBER 16 A2: Microbial Control (continued)

B2: Small Mold: Big Problem! Case Studies on Mold in a Manufacturing Facility (continued)

to microbial ingress. The goal of the knowledge sharing will be to incorporate elements into your own microbial control strategies and to improve programs for the future.

related to the presence of mold either in the environment or in the process of a pharmaceutical manufacturing facility.

The impact and response to the situations will be explored to provide insight into the prevention of future recurrence.

4:15 p.m. – 4:45 p.m.

What’s in Your Equipment?

Cheryl Essex, Head of Biologics Microbiological Control, Sanofi

4:15 p.m. – 4:45 p.m.

Responding to In-process Contaminations: A Case Study Brian J. Lloyd, PhD, Project Manager for New Programs, Pfizer Biotech

4:45 p.m. – 5:15 p.m.

Bioburden Intensity: An Integrated Approach to Environmental Monitoring Data Trending Austin W. Kuo, Prinicpal Research Scientist – Sterility Assurance, Eli Lilly and Company 5:15 p.m. – 5:45 p.m.

Questions and Answers/Discussion

4:45 p.m. – 5:15 p.m.

Antimicrobial Effectiveness Test Failure: A Case Study for Nasal Spray Product Mark P.J. Nabuurs, BASc Medical Microbiology, Merck & Co./Merck Sharpe & Dohme 5:15 p.m. – 5:45 p.m.

Questions and Answers/Discussion

5:45 p.m. – 7:00 p.m.

Networking Reception and Poster Presentations in Exhibit Hall

TUESDAY, OCTOBER 16 7:00 a.m. – 5:30 p.m.

Registration Open 7:00 a.m. – 8:30 a.m.

Continental Breakfast 7:15 a.m. – 8:15 a.m.

Breakfast Roundtable Moderator: Julie Barlasov-Brown, MBA, Associate Director Sterile and Microbiology QA, Merck & Co., Inc.

13TH ANNUAL PDA GLOBAL CONFERENCE ON PHARMACEUTICAL MICROBIOLOGY – AGENDA

13th Annual PDA Global Conference on Pharmaceutical Microbiology The Future of Pharmaceutical Microbiology: Small World, Big Opportunities October 15-17, 2018 | Bethesda, MD Exhibition: October 15-16 #PDAMICRO

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13TH ANNUAL PDA GLOBAL CONFERENCE ON PHARMACEUTICAL MICROBIOLOGY – AGENDA

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Connecting People, Science and Regulation®

TUESDAY, OCTOBER 16 (CONTINUED) 8:30 a.m. – 10:00 a.m.

P3: Plenary Simulcast from Berlin, Germany LIVE SIMULCAST BETWEEN BETHESDA, MD AND BERLIN, GERMANY

8:30 a.m. – 9:00 a.m.

GSK Vaccines Representative Invited 9:00 a.m. – 9:30 a.m.

CellTool Representative Invited 9:30 a.m. – 10:00 a.m.

Questions and Answers/Discussion 9:45 a.m. – 4:00 p.m.

Exhibit Hall Open 10:00 a.m. – 10:45 a.m.

Refreshment Break and Poster Presentations in Exhibit Hall 10:45 a.m. – 12:15 p.m.

A3: Environmental Monitoring Moderator: Christine Sherman, Director, Global Microbiology and Aseptic Network, Takeda

10:45 a.m. – 12:15 p.m.

B3: Biotech Products Moderator: Bo Chi, Microbiologist, CDER, FDA

In order to assure control of manufacturing facilities, environmental monitoring (EM) programs are critical to evaluate the effectiveness of disinfection programs, operator’s aseptic practices, and the engineering controls in place that provide appropriate conditions for manufacture.

These programs generate large amounts of data that can make it difficult to determine the best focus of valuable resources. This session will highlight a case study that provides guidance and tools to evaluate personnel gowning data to assess trends and risks. The second case study evaluated the impact of facility changes on sterility assurance and how to determine the most efficient and effective EM performance qualification after modification of the facility.

Microbial control and sterility assurance during manufacture of biotech products are critical to ensure product quality and patient safety. In this session, FDA and industry experts will present microbial control strategies and case studies in the context of current challenges encountered by the biotech industry.

10:45 a.m. – 11:15 a.m.

Leveraging Gown Monitoring Data to Improve Employee Performance Joe McCall, SM (NRCM), Technical Service Specialist, STERIS Life Sciences Jennifer Longstaff, Manufacturing Manager, Aseptic, Bausch + Lomb

10:45 a.m. – 11:15 a.m.

Microbiology and Biologic Manufacturing are Interdependent!

Jean Stuckey, Senior Principal Scientist, Patheon Biologics, LLC, part of Thermo Fisher Scientific

TUESDAY, OCTOBER 16 (CONTINUED) A3: Environmental Monitoring (continued)

B3: Biotech Products (continued)

11:15 a.m. – 11:45 a.m.

A Case Study of Environmental Monitoring Performance Qualification (EMPQ) Risk Analysis Frederic B. Ayers, Consultant Scientist, Eli Lilly and Company

11:15 a.m. – 11:45 a.m.

Current Challenges for Biotech Products Reyes Candau-Chacon, PhD, Quality Assessment Lead, Division of Microbiology Assessment, Branch IV, CDER, FDA

11:45 a.m. – 12:15 p.m.

Questions and Answers/Discussion

11:45 a.m. – 12:15 p.m.

Questions and Answers/Discussion

12:15 p.m. – 1:15 p.m.

Networking Luncheon, Passport Drawing, and Poster Presentations in Exhibit Hall 1:15 p.m. – 3:15 p.m.

A4: Risk Identification, Assessment, and Mitigation Moderator: Yeissa M. Chabrier-Roselló, PhD, Microbiology Reviewer, CDER, FDA

1:15 p.m. – 3:15 p.m.

B4: Predictably Irrational Microbiology Moderator: MaryEllen E. Usarzewicz, MS, Parenteral Manufacturing Support Lead, Analytical & Bioanalytical Operations, Microbiology, Bristol-Myers Squibb

A microbiological risk assessment is the scientificallybased process to estimate the likelihood of exposure to a microbial hazard and the resulting impact from this exposure. While the overall tools for quality risk management have been well described (ICH Q9), the practical applications for microbiology continue to present opportunities. This session will present three unique case studies on microbiological risk identification, assessment, and mitigation. It will include real-life perspectives on reactive microbiological risk assessment reports, improvements in aseptic processing to prevent microbial contamination, and manufacturing situations where the shelf life of the product influences the need to build risk reduction into the overall manufacturing processing. This session will emphasize the importance of design with a risk in mind for manufacturing operations upstream and downstream of the final drug product.

Despite best efforts at performing testing in a consistent, predictable fashion, the nature of microbiology is such that the living organisms sometimes do not provide rational results. Predictability also includes the repetitive nature of performing an action in the same way, even if the action (or test) does not seem rational. This session will focus on the predictably irrational nature of microbiology (from the perspective of both testing and results), including case studies on disinfectant efficacy evaluation and recovery of an anaerobic microorganisms from an aerobic aseptic process simulation.

1:15 p.m. – 1:45 p.m.

Specific Problems and Advice Associated with Writing Microbiological Risk Assessment Reports for Pharmaceutical/OTC/Medical Device Raw Material/ Component/Finished Product Contamination Dennis E. Guilfoyle, PhD, Senior Director, Microbiology Regulatory Compliance, Johnson & Johnson

1:15 p.m. – 1:45 p.m.

Sterility Test Recoveries and Process Simulation Design Kenneth Boone, Associate Director, Sterile & Microbiology Quality Assurance, Merck & Co., Inc.

1:45 p.m. – 2:15 p.m.

Case Study on Quality Risk Management Mitchell B. Garber, RPh, Director of Sterile and Biopharm Product Quality, GlaxoSmithKline

13TH ANNUAL PDA GLOBAL CONFERENCE ON PHARMACEUTICAL MICROBIOLOGY – AGENDA

13th Annual PDA Global Conference on Pharmaceutical Microbiology The Future of Pharmaceutical Microbiology: Small World, Big Opportunities October 15-17, 2018 | Bethesda, MD Exhibition: October 15-16 #PDAMICRO

1:45 p.m. – 2:15 p.m.

Principles to Consider for Setting Appropriate Bioburden Sample Hold Times Gretchen Brunner, Scientist II, Sanofi Genzyme Mark J. Kapeckas, Biologics Corporate Quality Global Program Manager, Sanofi Biologics

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13TH ANNUAL PDA GLOBAL CONFERENCE ON PHARMACEUTICAL MICROBIOLOGY – AGENDA

Connecting People, Science and Regulation®

TUESDAY, OCTOBER 16 (CONTINUED) – WEDNESDAY, OCTOBER 17 A4: Risk Identification, Assessment, and Mitigation (continued)

B4: Predictably Irrational Microbiology (continued)

2:15 p.m. – 2:45 p.m.

Risk Reduction in a Novel Aseptic Manufacturing Process Jessica G. Chiaruttini, PhD, Microbiologist, CDER, FDA

2:15 p.m. – 2:45 p.m.

Disinfectant Efficacy: Expect the Unexpected Jeffrey W. Heiser, Director, Microbiology, Boston Analytical

2:45 p.m. – 3:15 p.m.

Questions and Answers/Discussion

2:45 p.m. – 3:15 p.m.

Questions and Answers/Discussion

3:15 p.m. – 4:00 p.m.

Refreshment Break, Passport Drawing, and Poster Presentations in Exhibit Hall 4:00 p.m. – 5:30 p.m.

P4: Future Leaders Moderator: Kim Sobien, Principal Sterility Assurance Engineer, PETNET Solutions | A Siemens Company Solving regulatory and process problems in the small world of microbiology can seem overwhelming in the grand scheme of product control and quality. Yet sharing of these challenges by the leaders who have experienced them firsthand will ensure future success. This session will include four exciting case studies of problem resolution, project implementation, or deficiency awareness from the front lines of the microbiology laboratory or product review division.

4:00 p.m. – 4:15 p.m.

Free Range Facility Parenting: Challenges in Establishing Contamination Control, Environmental Monitoring, and Microbiological Testing Strategies for CAR T Therapies Joseph R. Sondej, Associate Director, QC Microbiology, Celgene 4:15 p.m. – 4:30 p.m.

It’s A Small World after All: Microbial Biogeography of a Manufacturing Facility Emily Elizabeth Castelloe, Rotational Development Program Associate, Pfizer Inc. 4:30 p.m. – 4:45 p.m.

Shedding Light on Your Water System: Implementation of an Online Water Bioburden Analyzer Brian H. Fitch, QC Associate III, Biogen 4:45 p.m. – 5:00 p.m.

Common Deficiencies for Drug Substance Manufacturing María José López Barragán, PhD, Microbiologist, CDER, FDA 5:00 p.m. – 5:30 p.m.

Questions and Answers/Discussion

WEDNESDAY, OCTOBER 17 7:00 a.m. – 12:15 p.m.

Registration Open 7:00 a.m. – 8:30 a.m.

Continental Breakfast

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7:15 a.m. – 8:15 a.m.

Breakfast Roundtable Moderator: Julie Barlasov-Brown, MBA, Associate Director Sterile and Microbiology QA, Merck & Co., Inc.

WEDNESDAY, OCTOBER 17 (CONTINUED) 8:30 a.m. – 10:00 a.m.

P5: USP Updates Moderator: Radhakrishna S. Tirumalai, PhD, Principal Scientific Liaison, US Pharmacopeial Convention Compatible with its overall mission, the role of USP in microbiology and sterility assurance is to develop public standards pertaining to microbiology that, along with other requirements, ensure the consistent quality of products.

This session will provide an overview on current and proposed activities of the USP General Chapters — Microbiology Expert Committee, with emphasis on revisions to existing chapters and new chapter proposals; discussion of a proposed new chapter proposal on a test for absence of B.cepacia complex; and discussion of bioburden resistance in materials being terminally sterilized and a simple method to determine this.

8:30 a.m. – 8:50 a.m.

Current Activities of the USP Microbiology Expert Committee David Hussong, PhD, Chief Technical Officer, Eagle Analytical Services 8:50 a.m. – 9:10 a.m.

Burkholderia Cepacia – Prominent Recalls, Screening Methods, and Controls Tony Cundell, PhD, Principal Consultant, Microbiological Consulting, LLC 9:10 a.m. – 9:30 a.m.

Estimating Microbial Resistance to Sterilization: The Boil Test James Agalloco, President, Agalloco & Associates Inc. 9:30 a.m. – 10:00 a.m.

Questions and Answers/Discussion 10:00 a.m. – 10:30 a.m.

Refreshment Break 10:30 a.m. – 12:00 p.m.

P6: Ask the Regulators Moderators: Amy McDaniel, PhD, Microbiologist, CDER, FDA John W. Metcalfe, PhD, Quality Assessment Lead, CDER, FDA During this interactive session, FDA will provide insight into questions posed by audience participants. The session is targeted to participants from all segments of the pharmaceutical industry, and will provide valuable perspectives from agency experts from reviewers of compounding, sterility assurance, aseptic processing, and terminal sterilization of small molecules. In addition, biotechnology professionals can seek input from agency experts on biosimilars and new molecules manufactured using biotechnology processes. Finally, expert field inspectors will provide their perspectives on inspection-related questions. Don’t miss this unique opportunity to interact with regulators in an open forum focused exclusively on your microbiology concerns!

13TH ANNUAL PDA GLOBAL CONFERENCE ON PHARMACEUTICAL MICROBIOLOGY – AGENDA

13th Annual PDA Global Conference on Pharmaceutical Microbiology The Future of Pharmaceutical Microbiology: Small World, Big Opportunities October 15-17, 2018 | Bethesda, MD Exhibition: October 15-16 #PDAMICRO

Panel Discussion Justin A. Boyd, Investigator, ORA, FDA Patricia F. Hughes Troost, PhD, Acting Branch Chief, Division of Microbiology Assessment, CDER, FDA (Invited) Stephen E. Langille, PhD, Acting Division Director, Division of Microbiology Assessment, CDER, FDA Laurie P. Norwood, Deputy Director, Division of Manufacturing Product Quality, OCBQ, CBER, FDA Kimberly L. Schultz, Biologist, CBER, FDA (Invited) 12:00 p.m.

Closing Remarks from the Conference Co-Chair Amy McDaniel, PhD, Microbiologist, CDER, FDA

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2018 PDA ENDOTOXINS WORKSHOP – GENERAL INFORMATION

Connecting People, Science and Regulation®

2018 PDA ENDOTOXINS WORKSHOP PROGRAM PLANNING COMMITTEE

A MESSAGE FROM THE PROGRAM CO-CHAIRS

Program Co-Chairs: Jennifer Farrington, PhD Associates of Cape Cod, Inc. Friedrich von Wintzingerode, PhD Roche-Genentech

Jay Bolden Eli Lilly and Company Jessica V. Hankins, PhD FDA Ned Mozier, PhD Pfizer, Inc. Johannes Reich, PhD Microcoat Biotechnologies GmbH Annette Bacchus PDA Josh Eaton PDA

Jennifer Farrington, PhD Associates of Cape Cod, Inc.

Friedrich von Wintzingerode, PhD Roche-Genentech

Dear Friends and Colleagues, As co-chairs of the Program Planning Committee, we invite you to attend the 2018 PDA Endotoxins Workshop, October 17-18 at the Bethesda North Marriott Hotel & Conference Center.

Endotoxin, a cell wall component of gram negative bacteria, can cause varying levels of immune responses when introduced to the blood system. As result, the onus is on the manufacturer of all parenteral drugs to control the possible contamination of endotoxin throughout the manufacturing process. As pharmaceutical manufacturing processes continue to become more streamlined and new therapy delivery continues to evolve, endotoxin control is advancing as well.

The 2018 PDA Endotoxins Workshop provides attendees with the latest access to current topics in the field, regulatory expectations, and new ideas to take back to their laboratories. The Planning Committee has worked diligently to create an agenda that includes a broad array of topics and sessions to appeal to the strategic managers, and practical advice to appeal to the tactical laboratory analyst.

Plenary and breakout sessions will focus on depyrogenation, microbial impurities, data integrity, and recombinant Factor C (rFc) applications. Additionally, members of the PDA Low Endotoxin Recovery Task Force will debut PDA’s new Technical Report. Alternative methods for detection of immune response indicators, such as the Monocyte Activation Test (MAT), will also be discussed.

Finally, posters, tabletop exhibits from leading suppliers, and networking sessions will provide the opportunity for one-on-one discussions and exposure to the latest technologies and ideas.

It is an exciting time in the world of endotoxin, and on behalf of the 2018 PDA Endotoxin Workshop Planning Committee, we hope to see you in Bethesda!

Sincerely, Co-chairs, 2018 PDA Endotoxins Workshop Program Planning Committee

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GENERAL INFORMATION For specific information on the 13th Annual PDA Global Conference on Pharmaceutical Microbiology, turn to page 3.

• Identify the best test method for endotoxin analysis for your company’s purpose

• Recognize possible inhibitors and enhancers of the LAL test • Select appropriate endotoxin specifications for your company’s products

REGISTER NOW

Online: pda.org/2018Endotoxins Fax: +1 (301) 986-1093 Questions? Please call +1 (301) 656-5900 ext. 115

VENUE

Bethesda North Marriott Hotel & Conference Center 5701 Marinelli Rd North Bethesda, MD 20852 Phone: +1 (301) 822-9200 Website: https://book.passkey.com/event/49551780/ owner/2644099/home Rate: Single/Double: $269, plus applicable taxes Cut-off Date: Monday, September 17, 2018. A PDA block of rooms is available on a first-come basis and must be secured by the cut-off date to receive the PDA rate. After the cut-off date, rooms will be available at the prevailing rate based on availability.

CONTINUING EDUCATION CREDITS PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms, and email the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive CPE credit.

ALERT: ACPE and the National Association of Boards of Pharmacy developed the Continuing Pharmacy Education (CPE) Monitor that allows pharmacists to electronically track their CPE credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE accredited activity. Always submit CPE activity claims as soon as possible and by the deadline specified on the CPE credit request form.

• Describe best practices for your company’s new or existing laboratories

WHO SHOULD ATTEND

Job Function: Biologist | Microbiologist | Operator/Technician | Pharmacist | Product Manager | Scientist/Researcher Departments: Biochemistry | Biology | Development | Manufacturing | Microbiology | Quality | Regulatory Affairs | Research | Technical Operations | Validation

WORKSHOP REGISTRATION HOURS

Wednesday, October 17: 11:30 a.m. - 5:45 p.m.

Thursday, October 18: 7:30 a.m. – 5:45 p.m.

COURSE REGISTRATION HOURS

Thursday, October 18: 7:30 a.m. – 4:00 p.m.

Friday, October 19: 7:30 a.m. – 4:00 p.m.

DRESS/ATTIRE Business casual attire is recommended for all events. Since the temperature in meeting rooms tends to be cool, please bring a jacket or sweater for your comfort.

SPECIAL REQUIREMENTS If you require special accommodations to fully participate, please attach a written description of your needs with your registration form. Specific questions can be directed to registration@pda.org.

CONTACT INFORMATION Conference Inquiries Annette Bacchus, Manager, Programs Tel: +1 (301) 656-5900 ext. 221 | Email: bacchus@pda.org Registration Customer Care Tel: +1 (301) 656-5900 ext. 115 | Email: registration@pda.org

2018 PDA Endotoxins Workshop ACPE # 0116-0000-18-017-L04-P | 1.0 CEUs Type of Activity: Knowledge

Exhibition/Sponsorship Inquiries David Hall, Vice President, Sales Tel: +1 (240) 688-4405 | Email: hall@pda.org

LEARNING OBJECTIVES:

Education Course Series Inquiries Stephanie Ko, Senior Manager, Lecture Education Tel: +1 (301) 656-5900 ext. 151 | Email: ko@pda.org

At the completion of this Workshop, attendees will be able to:

• Discuss complex interaction of endotoxins with

2018 PDA ENDOTOXINS WORKSHOP – GENERAL INFORMATION

2018 PDA Endotoxins Workshop

The Future of Endotoxins Testing: Guidance, Compliance, and Quality October 17-18, 2018 | Bethesda, MD Exhibition: October 17-18 #PDAENDOTOXINS

immune system

• Describe best practices for your company’s approach to address LER

pda.org/2018Endotoxins

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2018 PDA ENDOTOXINS WORKSHOP – AGENDA

Connecting People, Science and Regulation®

WEDNESDAY, OCTOBER 17 WEDNESDAY, OCTOBER 17 11:30 a.m. – 5:45 p.m.

Registration Open

1:45 p.m. – 2:00 p.m.

Welcome and Opening Remarks from Workshop Co-Chair Jennifer Farrington, PhD, Associate Director, Regulatory Affairs, Associates of Cape Cod, Inc. 2:00 p.m. – 3:30 p.m.

P1: rFC and Its Application Moderator: Ned Mozier, PhD, Senior Director, Pfizer Inc. The use of recombinant factor C (rFC) for endotoxin detection has been available for many years as an alternate to LAL-based testing. However, rFC has not gained a proportional use to date, although new trends suggest this might be changing. There are at least two sources of rFC available, and recent publications suggest it performs similarly on actual biotech samples to LAL. In some cases, there are advantages afforded by rFC. The purpose of this session is to review the background regarding the rFC invention, the data from industry comparing it to LAL, and the overall burden of changeover. Other factors, such as sustainability of using a natural animal source for LAL and future thinking about where our industry might be headed will be discussed.

2:00 p.m. – 2:30 p.m. rFC – From Genetic Engineering to Biomedical/Industrial Applications in Endotoxin Detection Lynne JL Ding, PhD, Professor, National University of Singapore 2:30 p.m. – 3:00 p.m. rFC – The Road Less Traveled: An Implementation Update and Shared Learning Jay Bolden, Senior Consultant Quality-Biologist, Eli Lilly and Company 3:00 p.m. – 3:30 p.m.

Questions and Answers/Discussion

3:15 p.m. – 6:30 p.m.

Exhibit Area Open 3:30 p.m. – 4:00 p.m.

Refreshment Break and Poster Presentations in Exhibit Area

POSTER PRESENTATIONS The following posters will be presented during all refreshment breaks on Wednesday and Thursday: 1. Faster, Further – Reliably and Sustainably. A New Product Offering for Recombinant Factor C Endotoxin Testing Gregory Devulder, PhD, Endotoxin Program Director, bioMérieux 2. The Automation of Endotoxin Testing: Streamlining Your QC Testing with Automated Endotoxin Testing and Process Optimization Robert Porzio, Product Manager, Lonza Walkersville Inc. 3. An Organized, Data Driven Approach to Endotoxin Investigations Matthew Paquette, Product Specialist – Technical Specialist, Charles River

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WEDNESDAY, OCTOBER 17 (CONTINUED) – THURSDAY, OCTOBER 18 4:00 p.m. – 5:30 p.m.

P2: Monocyte Activation Test (MAT): Considerations for Implementation in the Pharmaceutical Industry Moderator: Friedrich von Wintzingerode, PhD, Senior Manager Global Analytical Science & Technology Microbiology, Roche-Genentech When present in parenteral products, microbial pyrogenic substances (also referred to as Pathogen Associated Molecular Pattern, or PAMP) can cause life-threatening fevers. The human response to PAMPs is regulated by monocytes. The activation starts with PAMP binding to toll-like receptors (e.g., TLR2, TLR4, TLR7, TLR8, TLR9) and involves a cascade of intracellular reactions resulting in a release of pro-inflammatory cytokines. The traditional methods for pyrogen detection either require animal use for the Rabbit Pyrogen Test (RPT), or are limited to the detection of endotoxin (LAL). This session will describe considerations for implementation of the MAT in the pharmaceutical industry.

4:00 p.m. – 4:30 p.m.

MAT: The Stony Way to the Stars Peter Bruegger, DPS Head Bioassay and Microbiology, Lonza AG Basel 4:30 p.m. – 5:00 p.m.

MAT: How to Conduct a Risk Analysis and Develop a Test Protocol Ned Mozier, PhD, Senior Director, Pfizer Inc.

2018 PDA ENDOTOXINS WORKSHOP – AGENDA

2018 PDA Endotoxins Workshop

The Future of Endotoxins Testing: Guidance, Compliance, and Quality October 17-18, 2018 | Bethesda, MD Exhibition: October 17-18 #PDAENDOTOXINS

5:00 p.m. – 5:30 p.m.

Questions and Answers/Discussion 5:30 p.m. – 6:30 p.m.

Networking Reception in Exhibit Area

THURSDAY, OCTOBER 18 7:30 a.m. – 5:45 p.m.

Registration Open

7:30 a.m. – 8:30 a.m.

Continental Breakfast

8:30 a.m. – 10:00 a.m.

P3: Depyrogenation Moderator: Jennifer Farrington, PhD, Associate Director, Regulatory Affairs, Associates of Cape Cod, Inc. Endotoxin removal by depyrogenation is key to successful parenteral manufacturing. In recent years, USP has dedicated four chapters to depyrogenation. This session will discuss general depyrogenation, dry heat depyrogenation, depyrogenation by filtration, and endotoxin indicators. A formal risk analysis will be done for the removal of endotoxin in a basic parental process.

8:30 a.m. – 9:00 a.m.

New Ways to Think About Depyrogenation Karen Z. McCullough, MS, Principal Consultant, MMI Associates

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2018 PDA ENDOTOXINS WORKSHOP – AGENDA

Connecting People, Science and Regulation®

THURSDAY, OCTOBER 18 (CONTINUED) P3: Depyrogenation (continued) 9:00 a.m. – 9:30 a.m.

Industry Perspective on Depyrogenation Industry Representative Invited 9:30 a.m. – 10:00 a.m.

Questions and Answers/Discussion 9:45 a.m. – 5:15 p.m.

Exhibit Hall Open 10:00 a.m. – 10:30 a.m.

Refreshment Break and Poster Presentations in Exhibit Area 10:30 a.m. – 12:00 p.m.

P4: Endotoxins and Other Immune Modulating Impurities Moderator: Johannes Reich, PhD, GM Endotoxins, Microcoat Biotechnologie GmbH There are many factors that can stimulate the innate immune systems. Historically, analytical testing has focused on fever and the responses of the innate immune system, which are immediate and measurable responses. However, with the advent of biologics, the adaptive immune system responses have become more and more important. The innate immune system has been found to trigger adaptive immune responses. The growing knowledge of the interface between innate and adaptive immunity needs to be explored to adjust current microbial control concepts. Microbial impurities of parenterals can induce significant immune responses and negative effects on patient safety. In contrast, for vaccines, the presence of “microbial impurities” also may have beneficial effects. Adding defined amounts of stimulating components, such as “detoxified” LPS, to the product has shown to improve efficacy. The mechanisms behind this practice are still not fully understood and further research is needed. In this session, innate immune response-modulating impurities are explained and strategies for their control are discussed.

10:30 a.m. – 11:00 a.m.

FDA Perspective on Endotoxins and Other Immune Modulating Impurities U.S. Regulatory Representative Invited 11:00 a.m. – 11:30 a.m.

Endotoxin in the Adaptive Immune Response Kevin L. Williams, Senior Scientist, bioMérieux 11:30 a.m. – 12:00 p.m.

Questions and Answers/Discussion 12:00 p.m. – 1:30 p.m.

Lunch on Your Own. Exhibit Hall Closed. A listing of local restaurants is available at the PDA Registration Desk.

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THURSDAY, OCTOBER 18 (CONTINUED) 1:30 p.m. – 3:00 p.m.

Bacterial Endotoxin Testing and Data Integrity Breakouts Session 1: 1:30 p.m. – 2:00 p.m.

Session 2: 2:00 p.m. – 2:30 p.m.

Session 3: 2:30 p.m. – 3:00 p.m.

Attendees will participate in all breakouts, for 30 minutes each.

Data integrity continues to be an area of concern among industry and regulatory agencies. The five ALCOA principles encompass all quality data, including data generated using bacterial endotoxin test. In these breakout sessions, data integrity case studies and risk assessments using gel clot, kinetic, and automated endotoxin testing platforms will be presented. Additionally, attendees will participate in small group discussions to better understand data integrity and bacterial endotoxin testing.

Group A – Gel Clot Endotoxin Testing Moderator: Friedrich von Wintzingerode, PhD, Senior Manager Global Analytical Science & Technology Microbiology, Roche-Genentech

Group B – Kinetic Testing Moderator: Jessica V. Hankins, PhD, Microbiologist, CDER, FDA

Group C – Automated Testing Moderator: Jay Bolden, Senior Consultant Quality-Biologist, Global Quality Laboratories, Eli Lilly and Company

Risk Assessment of LAL Test Using Gel-Clot Technique Requiring Contemporaneous Verification Youwen Pan, PhD, Sr. Scientist, Genentech

Industry Perspective on Kinetic Testing Jim Henderson, Consultant QA, Eli Lilly and Company

Industry Perspective on Automated Testing Scott Kaszuba, QC Manager, Pfizer Inc. (Invited)

2018 PDA ENDOTOXINS WORKSHOP – AGENDA

2018 PDA Endotoxins Workshop

The Future of Endotoxins Testing: Guidance, Compliance, and Quality October 17-18, 2018 | Bethesda, MD Exhibition: October 17-18 #PDAENDOTOXINS

3:00 p.m. – 3:30 p.m.

Refreshment Break and Poster Presentations in Exhibit Area 3:30 p.m. – 4:45 p.m.

P5: Current LER Perspectives: Part 1 Moderator: Josh Eaton, Senior Project Manager, Scientific & Regulatory Affairs, PDA Members of PDA’s LER Task Force will present an overview of the three main topics from the LER technical report: 1) the underlying mechanisms and contributing factors of LER, 2) the potential clinical impact of the LER phenomenon, and 3) guidelines for developing LER hold-time study design and LER mitigation strategies. Following the technical report overview will be a discussion of a practical example of addressing LER in existing commercial products.

3:30 p.m. – 3:45 p.m.

LER Technical Report Overview Friedrich von Wintzingerode, PhD, Senior Manager Global Analytical Science & Technology Microbiology, Roche-Genentech 3:45 p.m. – 4:05 p.m.

Proposed Mechanism for LER Jack Levin, MD, Professor of Laboratory Medicine and Medicine, University of California School of Medicine, San Francisco 4:05 p.m. – 4:15 p.m.

Q&A with Jack Levin, MD

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2018 PDA ENDOTOXINS WORKSHOP – AGENDA

Connecting People, Science and Regulation®

THURSDAY, OCTOBER 18 (CONTINUED) P5: Current LER Perspectives: Part 1 (continued) 4:15 p.m. – 4:35 p.m.

Potential Safety Impact of LER and LER Mitigation Strategies Ned Mozier, PhD, Senior Director, Pfizer Inc. 4:35 p.m. – 4:45 p.m.

Q&A with Ned Mozier, PhD 4:45 p.m. – 5:00 p.m.

Break 5:00 p.m. – 6:00 p.m.

P5: Current LER Perspectives: Part 2 Moderator: Josh Eaton, Senior Project Manager, Scientific & Regulatory Affairs, PDA Members of PDA’s LER Task Force will present an overview of the three main topics from the LER technical report: 1) the underlying mechanisms and contributing factors of LER, 2) the potential clinical impact of the LER phenomenon, and 3) guidelines for developing LER hold-time study design and LER mitigation strategies. Following the technical report overview will be a discussion of a practical example of addressing LER in existing commercial products.

5:00 p.m. – 5:20 p.m.

LER Hold-Study Design Considerations Jennifer Farrington, PhD, Associate Director, Regulatory Affairs, Associates of Cape Cod, Inc. 5:20 p.m. – 5:30 p.m.

Q&A with Jennifer Farrington, PhD 5:30 p.m. – 5:50 p.m.

Case Study: Low Endotoxin Recovery for Existing Commercial Products Mark J. Kapeckas, Biologics Corporate Quality Program Manager, Sanofi Biologics 5:50 p.m. – 6:00 p.m.

Q&A with Mark J. Kapeckas 6:00 p.m.

Closing Remarks from Workshop Co-Chair Friedrich von Wintzingerode, PhD, Senior Manager Global Analytical Science & Technology Microbiology, Roche-Genentech

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October 18-19, 2018 | Bethesda, MD

13TH ANNUAL PDA GLOBAL CONFERENCE ON PHARMACEUTICAL MICROBIOLOGY COURSE SERIES Following the 13th Annual PDA Global Conference on Pharmaceutical Microbiology, from October 18-19, PDA Education will offer four courses designed to advance your knowledge.

CONTINUING EDUCATION FOR PHARMACISTS PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms, and email the CPE credit request to the address stated on the form. Attendees must be present during the entire event to receive CPE credit.

ALERT: ACPE and the National Association of Boards of Pharmacy developed the CPE Monitor that allows pharmacists to electronically track their CPE credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE accredited activity. No exceptions can be given. Always submit CPE activity claims immediately following the event and by the deadline specified on the CPE credit request form.

CONTINUING EDUCATION FOR ENGINEERS PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of CPC activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDHs) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

Contact Stephanie Ko via email at ko@pda.org to learn more.

CLASS SCHEDULE All lecture courses begin at 8:30 a.m. and end at 4:00 p.m. Please arrive at your course location approximately 30 minutes before the start of the course to register and receive your name badge. Please be sure to bring your confirmation letter as proof of registration during check-in. PDA will not allow persons to attend a course without payment or guarantee of payment.

7:30 a.m. – 8:30 a.m.: Continental Breakfast 10:00 a.m. – 10:15 a.m.: Morning Break 12:00 p.m. – 1:00 p.m.: Lunch 2:30 p.m. – 2:45 p.m.: Afternoon Break

pda.org/2018MicroCourses

13TH ANNUAL PDA GLOBAL CONFERENCE ON PHARMACEUTICAL MICROBIOLOGY COURSE SERIES

13th Annual PDA Global Conference on Pharmaceutical Microbiology Course Series

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13TH ANNUAL PDA GLOBAL CONFERENCE ON PHARMACEUTICAL MICROBIOLOGY COURSE SERIES

Connecting People, Science and Regulation®

13TH ANNUAL PDA GLOBAL CONFERENCE ON PHARMACEUTICAL MICROBIOLOGY COURSE SERIES INVESTIGATING MICROBIAL DATA DEVIATIONS Location: Bethesda, MD Date: Thursday, October 18 Duration: 1 day Time: 8:30 a.m. – 4:00 p.m.

Course Number: 441 ACPE #0116-0000-14-073-L04-P | 0.6 CEUs Type of Activity: Knowledge

This course will provide practical insights into both the regulatory and scientific elements that must be taken into consideration when investigating microbiological data deviations. Participants will come away with an understanding not only of what the considerations are, but also a practical approach to designing and conducting investigations into microbiological test data that appears inconsistent with expectations and trends.

WHO SHOULD ATTEND This course will be of value to quality control staff who conduct and assess the results of microbiological testing.

It will also be of benefit to those quality control and quality assurance staff who conduct investigations into microbiological data deviations and write and approve reports of those investigations. Analysts, laboratory supervisors, and quality assurance staff and managers will all benefit from attendance at this course.

LEARNING OBJECTIVES Upon completion of this course, you will be able to:

• Identify microbiological test results that deviate from anticipated results and trends • Explain the responsibilities of laboratory, manufacturing, and quality assurance staff in preparing for, conducting, reviewing, and documenting investigations into microbiological data deviations • Describe the essential elements of reports of investigations into microbiological data deviations • Discuss the benefits of flowcharts, checklists, and process flow diagrams as they apply to the investigation process • Apply the concepts learned in situations involving microbiological data deviations when necessary

FACULTY Jeanne Moldenhauer, Vice President, Excellent Pharma Consulting

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REGULATORY ASPECTS OF MICROBIOLOGY IN A NON-STERILE ENVIRONMENT Location: Bethesda, MD Date: Thursday, October 18 Duration: 1 day Time: 8:30 a.m. – 4:00 p.m.

Course Number: 221 ACPE #0116-0000-17-043-L04-P | 0.6 CEUs Type of Activity: Knowledge

This course discusses various regulations and how they impact non-sterile manufacturing, including the setting of specifications, development of processes, holding times, preservation issues, cleaning, sanitization, and the requirements for the testing of recovered microorganisms.

Thoughts regarding in-house microorganisms that may be considered as “specified” will also be discussed. A case study will be included where teams will discuss some of the various regulatory issues that are encountered in a plant environment and report their findings to all of the participants.

WHO SHOULD ATTEND This course is for individuals in quality assurance/quality control, regulatory compliance, manufacturing, research and development, technology transfer, and project management.

LEARNING OBJECTIVES Upon completion of this course, you will be able to:

• Identify microbiological regulatory concerns with non-sterile incoming components, in-process, active pharmaceutical ingredients (API), and finished product • Discuss key microbiological issues involved in the manufacturing of non-sterile products • Review the establishment of a non-sterile microbiological control program • Identify gaps with current regulatory and industry expectations • Explain how USP<1115>, Bioburden Control of NonSterile Drug Substances and Products, complements the development of non-sterile products

FACULTY Barry Friedman, PhD, Consultant, Barry A. Friedman, PhD, LLC

October 18-19, 2018 | Bethesda, MD

13TH ANNUAL PDA GLOBAL CONFERENCE ON PHARMACEUTICAL MICROBIOLOGY COURSE SERIES MICROBIOLOGICAL RISK ASSESSMENT OF A PHARMACEUTICAL MANUFACTURING PROCESS Location: Bethesda, MD Date: Friday, October 19 Duration: 1 day Time: 8:30 a.m. – 4:00 p.m.

Course Number: 382 ACPE #0116-0000-17-042-L04-P | 0.6 CEUs Type of Activity: Knowledge

This course is designed for quality and manufacturing professionals to develop a microbiological risk assessment based on specific pharmaceutical products or processes.

Participants will learn to formulate a strategy to proactively look for areas of potential microbial contamination and minimize activities or processes that may cause risk.

Specific activities will include:

• Reviewing how microbiological quality may be impacted

DEVELOPING A MICROBIAL MONITORING PLAN AND LEVERAGING NEW TECHNOLOGIES FOR EFFECTIVE STERILITY ASSURANCE IN ASEPTIC PROCESSES NEW COURSE Location: Bethesda, MD Date: Friday, October 19 Duration: 1 day Time: 8:30 a.m. – 4:00 p.m.

Course Number: 542 ACPE #0116-0000-18-004-L04-P | 0.6 CEUs Type of Activity: Application

This course provides tools, rationales, and guidelines for designing a strong cleanroom microbial monitoring plan and for leveraging and introducing new technologies for effective sterility assurance in aseptic processes.

Specific topics include:

• FDA and EU GMP requirements for total particle and microbial environmental monitoring for aseptic processes

in steps throughout the manufacturing process • Identifying risk assessment tools, including the Failure Modes and Effects Analysis (FMEA) approach • Creating an example FMEA, incorporating process steps that may have microbial contamination risk • Using the FMEA approach to evaluate process and behavior

• Design of an environmental monitoring plan based on

WHO SHOULD ATTEND

LEARNING OBJECTIVES

Individuals from the following areas will benefit from attending this course:

Upon completion of this course, you will be able to:

• Manufacturing/Facility Management • Product Development • Project Management • QA/QC • Microbiology • Validation

LEARNING OBJECTIVES Upon completion of this course, you will be able to:

• Identify the aspects of pharmaceutical manufacturing that may affect microbiological quality

• Develop an FMEA, quantifying risk for individual process steps

risk assessment and process analysis

• New technologies and instruments for environmental monitoring: features, scientific descriptions, and benefits

• New technologies and instruments for environmental monitoring implementation: FDA and EU GMP requirements and implementation/validation steps

• Design a microbial monitoring plan for an effective sterility assurance in aseptic processes

• Explain the implementation of new technologies for an effective sterility assurance in aseptic processes

FACULTY Gilberto Dalmaso, PhD, Senior Advisor and Pharma Customer Advisory Team Manager, Life Sciences Division, Particle Measuring Systems

13TH ANNUAL PDA GLOBAL CONFERENCE ON PHARMACEUTICAL MICROBIOLOGY COURSE SERIES

13th Annual PDA Global Conference on Pharmaceutical Microbiology Course Series

• Quantitatively evaluate steps within a process • Develop ways to reduce or minimize activities that may increase microbial contamination risk

FACULTY Peter Noverini, Field Applications Scientist, Azbil BioVigilant, Inc.

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13th Annual PDA Global Conference on Pharmaceutical Microbiology (Oct. 15-17) and 2018 PDA Endotoxins Workshop (Oct. 17-18)

Questions? Call registration at +1 (301) 656-5900 ext. 115

Bethesda North Marriott Hotel & Conference Center | Bethesda, MD Exhibition: Oct. 15-16 | Courses: Oct. 18-19 Your consent is important. We manage your personal data responsibly.

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PDA #441 Investigating Microbial Data Deviations (October 18) PDA #221 Regulatory Aspects of Microbiology in a Non-Sterile Environment (October 18) PDA #382 Microbiological Risk Assessment of a Pharmaceutical Manufacturing Process (October 19) PDA #542 Developing a Microbial Monitoring Plan and Leveraging New Technologies for Effective Sterility Assurance in Aseptic Processes (October 19)

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Course #542

 $ 1,192  $ 1,431  $ 795

 $ 1,192  $ 1,431  $ 795

 $ 1,192  $ 1,431  $ 795

 $ 1,192  $ 1,431  $ 795

 $ 1,325  $ 1,590  $ 795

 $ 1,325  $ 1,590  $ 795

 $ 1,325  $ 1,590  $ 795

 $ 1,325  $ 1,590  $ 795

* For this member type or discounted rate, online registration is not available and must be faxed in.

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Special Dietary Requirements (Please be specific):

Please note: In order to receive the prevailing rate, your registration(s) with payment must be received by PDA by 5:00 p.m. ET on or before the date noted.

* For this member type or discounted rate, online registration is not available and must be faxed in. † You must be a member to take advantage of this rate.

Payment Options All cards are charged in US$. Group Registration: Register 3 people from the same organization as a group (at the same time) for the CONFERENCE or WORKSHOP and receive the 4th registration free.

Other discounts cannot be applied. All forms MUST be faxed in together.

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 By Credit Card – Clearly indicate account number, expiration date, and billing address. Please bill my:  American Express  MasterCard  VISA  Credit Card Guarantee Only

Total amount $ Account Number Exp. Date Name (exactly as it appears on card) Signature Billing Address (must match credit card statement) PDA Federal Tax I.D. #52-1906152 City State Zip Code

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Wire Transfer Payments: If you require wire transfer, please contact registration@pda.org.

CONFIRMATION: A letter of confirmation will be sent to you once payment is received. You must have this written confirmation to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. Please be advised that if your payment or written cancellation notice is not received by August 16, 2018, your credit card will be charged the prevailing rate. SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including onsite for a fee of $200. If you are a non-member substituting for a member, you will be required to pay the difference in the non-member fee. If you are pre-registering as a subsitute attendee, indicate this on the registration form. REFUNDS: Refund requests must be in writing and faxed to +1 (301) 986-1093. (Emails and phone messages are not accepted). Refunds for Conference/Workshop: If your written request is received on or before August 16, 2018, you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. Onsite registrants are not guaranteed to receive Conference materials until all advanced registered attendees receive them. PDA reserves the right to modify the material or speakers/instructors without notice or to cancel an event. If an event must be canceled, registrants will be notified by PDA in writing as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancelation. For more details, contact PDA at info@pda.org or +1 (301) 656-5900. PLEASE NOTE THAT YOUR PHOTO ID WILL BE REQUIRED IN ORDER TO PICK UP BADGE MATERIALS ONSITE. THIS IMPORTANT SECURITY PROCEDURE WILL PREVENT ANYONE OTHER THAN THE REGISTRANT FROM PICKING UP THEIR BADGES AND MATERIALS. REFUNDS FOR COURSES: If your written request is received by September 18, 2018, you will receive a full refund minus a $200 processing fee. After that time, no refunds will be approved. PDA reserves the right to modify the material, or speakers/instructors without notice, or to cancel an event. If an event must be canceled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancelation.

RECORDING: Tape recordings are prohibited at all PDA Conferences. ATTENDEE LIST: The attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event.

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