2017 PDA Endotoxins Workshop by Parenteral Drug Association

The Parenteral Drug Association presents the...

2017 PDA Endotoxins Workshop October 18-19, 2017 | Bethesda, MD Bethesda North Marriott Hotel & Conference Center Exhibition: October 18-19

#2017Endotoxins

Save the Date! pda.org/2017Endotoxins

October 18-19, 2017 | Bethesda North Marriott Hotel & Conference Center | Bethesda, MD Exhibition: October 18-19

2017 PDA ENDOTOXINS WORKSHOP PROGRAM PLANNING COMMITTEE

#2017Endotoxins

A MESSAGE FROM THE PROGRAM CO-CHAIRS

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

Jay Bolden Eli Lilly and Company Allen L. Burgenson, MS Lonza Walkersville, Inc. John A. Dubczak Charles River Laboratories, Inc. Malcolm A. Finkelman, PhD Associates of Cape Cod, Inc. Jessica V. Hankins FDA Ned M. Mozier, PhD Pfizer Inc. Johannes Reich, PhD Microcoat Biotechnologie GmbH Ingo Spreitzer Paul-Ehrlich-Institut Josh Eaton, PMP PDA Brooke Schneider, CMP PDA

Jennifer Farrington, PhD Friedrich von Associates of Cape Cod, Inc. Wintzingerode, PhD Roche Diagnostics GmbH Dear Friends and Colleagues, As co-chairs of the Program Planning Committee, we invite you to attend the 2017 PDA Endotoxins Workshop! Endotoxin, a cell wall component of gram negative bacteria, can cause varying levels of immune responses when introduced to the blood system. As a result, the onus is on the manufacturers of all parenteral drugs to control possible endotoxin contamination throughout the manufacturing process. As pharmaceutical manufacturing processes continue to become more streamlined and new therapy delivery continues to evolve, endotoxin control is evolving as well. The 2017 PDA Endotoxins Workshop will provide attendees with access to the most current topics in the field, regulatory expectations, and new ideas to take back to their laboratories. The 2017 Program Planning Committee has worked diligently to select a broad array of session topics to appeal to strategic managers and practical advice to assist tactical laboratory analysts. Plenary sessions will focus on academic perspectives on the limulus amebocyte lysate (LAL) assay and endotoxin structure and diversity. Regulatory and industry perspectives on practical issues related to endotoxins will also be addressed. Additional sessions will include concrete advice for bacterial endotoxins test (BET) laboratories and will address the emerging role of beta-glucans, not only as interference to the BET, but also as having a potential impact on patient safety. There will also be discussions on the monocyte activation test (MAT) and data integrity. Case studies will be presented in small, interactive breakout sessions, allowing attendees to discuss real-life problems and potential solutions. Finally, networking opportunities will allow attendees to make new connections and discuss the latest technologies and innovations. It is an exciting time in the world of endotoxin, and on behalf of the 2017 PDA Endotoxins Workshop Program Planning Committee, we look forward to seeing you in Bethesda!

2017 PDA ENDOTOXINS WORKSHOP â&#x20AC;&#x201C; GENERAL INFORMATION

2017 PDA Endotoxins Workshop

2017 PDA ENDOTOXINS WORKSHOP – GENERAL INFORMATION

Connecting People, Science and Regulation®

GENERAL INFORMATION, REGISTRATION For specific information on the 12th Annual PDA Global Conference on Pharmaceutical Microbiology, turn to page 3.

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 mail 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. 2017 PDA Endotoxins Workshop CPE: ACPE # 0116-0000-17-012-L04-P | 1.05 CEUs Type of Activity: Knowledge

LEARNING OBJECTIVES Upon completion of this Workshop, you will be able to: • Identify the best test method for endotoxin analysis for your company’s purposes • Recognize possible inhibitors and enhancers of the LAL test • Select appropriate endotoxin specifications for your company’s products • Describe best practices for your company’s new or existing laboratories

WORKSHOP REGISTRATION HOURS Wednesday, October 18: 11:30 a.m. – 5:30 p.m. Thursday, October 19: 7:00 a.m. – 4:00 p.m.

DRESS/ATTIRE Business casual attire is recommended for all events. The temperature in the meeting rooms tends to be cool, so a jacket or sweater is advised 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 Workshop Inquiries Brooke Schneider, CMP Manager, Programs Tel: +1 (301) 656-5900, ext. 111 Email: schneider@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

2017 PDA ENDOTOXINS WORKSHOP

Find the Best Exhibit and/or Sponsorship Option for Your Ideal Audience The 2017 PDA Endotoxins Workshop will enable you to connect with key decision makers from the pharmaceutical manufacturing industry. High-profile sponsorships are available for lanyards, notepads, tote bags, pens, refreshment breaks, luncheons, and the Networking Reception. Don’t miss this opportunity to strengthen brand image, increase visibility, and gain access to industry leaders. For exhibit and/or sponsorship information, please contact: David Hall, Vice President, Sales Cell: +1 (240) 688-4405 Email: hall@pda.org Alison Caballero, Senior Coordinator, Sales Phone: +1 (301) 656-5900 x 135 Email: caballero@pda.org pda.org/2017Endotoxins #2017Endotoxins

October 18-19, 2017 | Bethesda North Marriott Hotel & Conference Center | Bethesda, MD Exhibition: October 18-19

#2017Endotoxins

WEDNESDAY, OCTOBER 18 11:30 a.m. – 5:30 p.m. Registration Open 1:15 p.m. – 1:30 p.m. Welcome and Opening Remarks from Conference Co-Chair Jennifer Farrington, PhD, Associate Director, Regulatory Affairs, Associates of Cape Cod, Inc. 1:30 p.m. – 3:30 p.m. P1: Opening Plenary: Academic Perspectives on the Limulus Amebocyte Lysate Assay and Endotoxin Structure and Diversity Moderator: Jessica V. Hankins, PhD, Microbiology Reviewer, CDER, FDA Session Description: The limulus amebocyte lysate (LAL) assay is the standard test method used to detect endotoxin in pharmaceutical products and medical devices. Although the overall biosynthesis of endotoxin is well conserved among Gram-negative bacteria, many organisms possess quite diverse endotoxin structures. This session will highlight the discovery and background of the LAL test and standardization of the lysate and reference standard endotoxin used in bacterial endotoxin testing. Additionally, attendees will gain a broad overview of endotoxin biosynthesis, the structural diversity of endotoxins, and the mechanisms which regulate this enzymatic machinery. 1:30 p.m. – 2:15 p.m. The LAL Test: Discovery, Development and Applications Jack Levin, MD, Professor of Laboratory Medicine, University of California, San Francisco 2:15 p.m. – 3:00 p.m. How Gram-Negative Bacteria Harden Their Armor: Diversity of Endotoxin Structure M. Stephen Trent, PhD, Professor, Department of Infectious Diseases, The University of Georgia 3:00 p.m. – 3:30 p.m. Questions and Answers/Discussion 3:15 p.m. – 7:30 p.m. Exhibit Area Open 3:30 p.m. – 4:15 p.m. Refreshment Break in Exhibit Area 4:15 p.m. – 6:15 p.m. P2: Practical Issues with Endotoxin Testing and Regulatory Responsibilities of Sponsors Moderator: Allen L. Burgenson, MS, Manager, Regulatory Affairs, Lonza Walkersville, Inc. Session Description: This session will provide information on the regulatory responsibilities of sponsors filing New Drug Applications (NDAs) or Biologics License Applications (BLAs) with the U.S. FDA, and practical testing information. 4:15 p.m. – 4:45 p.m. Regulatory Perspective on Practical Issues with Endotoxin Testing and Regulatory Responsibilities of Sponsors Center for Drug Evaluation and Research, U.S. FDA Representative Invited 4:45 p.m. – 5:15 p.m. Determining Endotoxins Limits for Raw Materials and Active Pharmaceutical Ingredients (APIs) Amber Dellar, Senior Operational Excellence Specialist, Pfizer Inc.

2017 PDA ENDOTOXINS WORKSHOP – AGENDA

2017 PDA Endotoxins Workshop

2017 PDA ENDOTOXINS WORKSHOP – AGENDA

Connecting People, Science and Regulation®

WEDNESDAY, OCTOBER 18 – THURSDAY, OCTOBER 19 P2: Practical Issues with Endotoxin Testing and Regulatory Responsibilities of Sponsors (continued) 5:15 p.m. – 5:45 p.m. Horseshoe Crabs and the Limulus Test: The Blue Bloods of Parenteral Quality Control John A. Dubczak, General Manager Endotoxin and Microbial Detection, Charles River Laboratories, Inc. 5:45 p.m. – 6:15 p.m. Questions and Answers/Discussion 6:15 p.m. – 7:30 p.m. Networking Reception in Exhibit Area

THURSDAY, OCTOBER 19 7:00 a.m. – 4:30 p.m. Registration Open 7:00 a.m. – 8:30 a.m. Continental Breakfast 7:15 a.m. – 8:15 a.m. Breakfast Session: Data Integrity Moderator: Jennifer Farrington, PhD, Associate Director, Regulatory Affairs, Associates of Cape Cod, Inc. Session Description: This session will provide the latest regulatory perspective on data integrity and Part 11 compliance specific to endotoxin testing. We will cover why it is a concern to the regulatory authorities and other areas of concern during limulus amebocyte lysate (LAL) testing. 7:15 a.m. – 7:45 a.m. Office of Regulatory Affairs, U.S. FDA Representative Invited 7:45 a.m. – 8:15 a.m. Questions and Answers/Discussion 8:30 a.m. – 10:00 a.m. P3: Beta-Glucans: Practical Issues Associated with Pharmaceutical Manufacturing, Effects on Bacterial Endotoxin Testing, and Potential Impact on Patient Safety Moderator: Jessica V. Hankins, PhD, Microbiology Reviewer, CDER, FDA Session Description: Beta-glucans are large polysaccharides found in the cell walls of various eukaryotic and prokaryotic organisms. These polysaccharides possess immunostimulatory properties and are potential contaminants of parenteral drugs and medical devices. This session will focus on the structure (1→3)-β-D-glucan, its sources as a contaminant, its effect on LAL-based endotoxin testing, mitigation approaches, and potential impact to patient safety. 8:30 a.m. – 8:50 a.m. Beta-Glucan Impurities: Challenges in the Detection and Removal in GMP Manufactured Therapeutic Antibodies Kim Vigor, QC Manager, Biotherapeutics Development Unit, Cancer Research UK 8:50 a.m. – 9:10 a.m. (1→3)-β-D-Glucan: Properties, Sources, Bacterial Endotoxins Test Interference and Mitigation Strategies Malcolm A. Finkelman, PhD, Director, Clinical Development, Associates of Cape Cod, Inc.

October 18-19, 2017 | Bethesda North Marriott Hotel & Conference Center | Bethesda, MD Exhibition: October 18-19

THURSDAY, OCTOBER 19 (CONTINUED)

#2017Endotoxins

P3: Beta-Glucans: Practical Issues Associated with Pharmaceutical Manufacturing, Effects on Bacterial Endotoxin Testing, and Potential Impact on Patient Safety (continued) 9:10 a.m. – 9:40 a.m. Parenteral Safety of Beta-Glucans Christine Schubert, DVM, PhD, DABT, Roche Pharmaceutical Research and Early Development, Roche Innovation Center Basel 9:40 a.m. – 10:00 a.m. Questions and Answers/Discussion 9:45 a.m. – 4:15 p.m. Exhibit Area Open 10:00 a.m. – 10:45 a.m. Refreshment Break in Exhibit Area 10:45 a.m. – 12:50 p.m. Concurrent Breakouts Attendees will participate in both breakouts, each 60 minutes long. After Session 1, attendees will switch and the breakouts will be repeated. Session 1: 10:45 a.m. – 11:45 a.m. | Session 2: 11:50 a.m. – 12:50 p.m. Group A – Case Study 1: Setting Endotoxin Specifications Moderator: Jay Bolden, Associate Senior Consultant Biologist, Global Quality Laboratories, Eli Lilly and Company Session Description: Endotoxin specification calculations for injectable drug products are harmonized in the major compendia. This session will present a case study and give participants the opportunity to create a drug product and drug substance endotoxin specification control strategy, while mitigating for unusual circumstances and balancing considerations for patient safety, the threshold pyrogenic dose constant, analytical and process capabilities, and reliable market supply. Session 1: 10:45 a.m. – 11:05 a.m. Review of Case Study

Session 2: 11:50 a.m. – 12:10 p.m. Review of Case Study

11:05 a.m. – 11:25 a.m. Small Group Discussion

12:10 p.m. – 12:30 p.m. Small Group Discussion

11:25 a.m. – 11:45 a.m. Group Reports

12:30 p.m. – 12:50 p.m. Group Reports

Group B – Case Study 2: Setting in-Process Endotoxin Limits Moderator: Friedrich von Wintzingerode, PhD, Senior Manager Microbiology, Roche Diagnostics GmbH Session Description: There is a lack of detailed guidance for setting endotoxin in process limits (alert levels and action limits) for biologics. This session will present a case study which allows participants to understand the underlying rationales and challenges. Aspects of method alignment between different production sites will also be discussed. Session 1: 10:45 a.m. – 11:05 a.m. Review of Case Study

Session 2: 11:50 a.m. – 12:10 p.m. Review of Case Study

11:05 a.m. – 11:25 a.m. Small Group Discussion

12:10 p.m. – 12:30 p.m. Small Group Discussion

11:25 a.m. – 11:45 a.m. Group Reports

12:30 p.m. – 12:50 p.m. Group Reports

2017 PDA ENDOTOXINS WORKSHOP – AGENDA

2017 PDA Endotoxins Workshop

2017 PDA ENDOTOXINS WORKSHOP – AGENDA

Connecting People, Science and Regulation®

THURSDAY, OCTOBER 19 (CONTINUED) 12:50 p.m. – 2:00 p.m. Networking Luncheon 2:00 p.m. – 3:30 p.m. Small Group Discussion: Pyrogen Test Comparison Moderator: Friedrich von Wintzingerode, PhD, Senior Manager Microbiology, Roche Diagnostics GmbH Session Description: During this session, the main difference between the rabbit pyrogen test (RPT) and the monocyte activation test (MAT) will be illustrated, focusing on the biological impact of the sample versus the quantification of endotoxin, based on the bacterial endotoxins test (BET). The relevance of non-endotoxin pyrogens (NEP) and synergistic effects will be discussed. The legal and regulatory implications of the MAT in Europe and the U.S. will be highlighted. 2:00 p.m. – 2:25 p.m. Monocyte Activation Test: Industry Perspective Ned M. Mozier, PhD, Senior Director, Pfizer Inc. 2:25 p.m. – 2:50 p.m. Monocyte Activation Test: Development Ingo Spreitzer, Acting Head, 1/3 Microbial Safety, Paul-Ehrlich-Institut 2:50 p.m. – 3:30 p.m. Small Group Discussion 3:30 p.m. – 4:15 p.m. Refreshment Break in Exhibit Area 4:15 p.m. – 5:45 p.m. P4: BET Laboratories: Practical Advice Moderator: Jennifer Farrington, PhD, Associate Director, Regulatory Affairs, Associates of Cape Cod, Inc. Session Description: Whether you use the bacterial endotoxin test to analyze in-process materials, finished pharmaceutical drugs, medical devices, biologics or water systems, proper laboratory controls, and understanding of the test is critical to success. This session will explore limulus amebocyte lysate (LAL) test interferences and essential laboratory controls and assay set up. Attendees will leave with practical advice to solve common inhibitory or enhancement problems and a more extensive knowledge of areas for which to be on the lookout when setting up a new laboratory and conducting ongoing review of the existing labs. 4:15 p.m. – 4:45 p.m. Detection of Endotoxins in Pharmaceutical Operations John A. Dubczak, General Manager Endotoxin and Microbial Detection, Charles River Laboratories, Inc. 4:45 p.m. – 5:15 p.m. Laboratory Prerequisites for a Successful Bacterial Endotoxins Test Veronika Wills, MSc, Associate Manager, Technical Services, Associates of Cape Cod, Inc. 5:15 p.m. – 5:45 p.m. Questions and Answers/Discussion 5:45 p.m. Closing Remarks from Conference Co-Chair Friedrich von Wintzingerode, PhD, Senior Manager Microbiology, Roche Diagnostics GmbH

The Parenteral Drug Association presents the...

12th Annual PDA Global Conference on Pharmaceutical Microbiology October 16-18, 2017 | Bethesda, MD

Bethesda North Marriott Hotel & Conference Center Exhibition: October 16-17

#PDAMicro

Solving Microbiological Challenges and Sustaining Success through a Culture of Collaboration 2017 PDA Endotoxins Workshop: October 18-19 | Workshop Exhibition: October 18-19 12th Annual PDA Global Conference on Pharmaceutical Microbiology Course Series: October 19-20

pda.org/2017Micro This preliminary agenda is current as of August 3, 2017 RECORDINGS ARE PROHIBITED AT ALL PDA EVENTS

12TH 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 Vinayak B. Pawar, PhD FDA

Edward S. Balkovic, PhD MicroBio Technical Support Julie Barlasov, MBA Merck & Co./Merck Sharp & Dohme Renée Blosser FDA Walid El Azab, Ind. Ph. STERIS Corporation Marsha Steed (Hardiman) ValSource, LLC Amy McDaniel, PhD Pfizer Inc. John W. Metcalfe, PhD FDA Michael J. Miller, PhD Microbiology Consultants, LLC Wendy G. Tan, PhD FDA CAPT Sharon K. Thoma, PharmD FDA Edward Tidswell, PhD Merck & Co./Merck Sharp & Dohme Radhakrishna S. Tirumalai, PhD U.S. Pharmacopeial Convention MaryEllen E. Usarzewicz, MS Bristol-Myers Squibb Eric J. Ward, MBA Boston Analytical Richard V. Levy, PhD PDA

On behalf of the Program Planning Committee, we extend a personal invitation to you to attend the 12th Annual PDA Global Conference on Pharmaceutical Microbiology. The Committee members were inspired to create a highly value-added agenda in light Kim Sobien Vinayak B. Pawar, PhD of the continuing changes PETNET Solutions | FDA to and challenges of global A Siemens Company pharmaceutical manufacturing that have emerged as the industry continues to grow. This Conference is designed to meet the unique needs of pharmaceutical microbiologists and interdisciplinary scientists involved in manufacturing and regulating the pharmaceutical industry. The agenda encompasses a wide variety of issues pharmaceutical microbiologists face and work in partnership to solve on a daily basis. An intriguing Conference keynote address will provide insight into the current dilemma of the alarming rate of antimicrobial resistance reported in patients. With fewer new antibiotics on the horizon and our need for alternative approaches, the focus will be on the potential use of vaccines to combat resistance, thus opening new doors for biotech manufacturing and microbiological testing. In subsequent sessions, you will hear case studies from industry experts about overcoming manufacturing obstacles when drugs, delivery devices, and biologics are combined to create new products. Regulatory experts will explain the complexities involved in ensuring that combination product regulation is as clear, consistent, and predictable as promised. Day one culminates with fresh perspectives and case studies of using teamwork to solve unique microbiology mysteries in the inspiring “Emerging Leaders” session. Day two of the Conference opens with the insightful real-life story of a microbiologist prevailing in a life-threatening battle against bacteria. The Committee’s own Marsha Steed (Hardiman) will deliver a unique perspective of her medical journey and reliance on the quality, safety, efficacy, and sterility of multiple pharmaceutical and medical device products manufactured by our industry. New this year is a U.S. FDA update on human drug compounding. An all-U.S. FDA speaker panel will address the unique needs of this industry, focusing on developing regulatory policy, facility inspections, cGMP requirements, and compounded drug quality. This is an essential session for attendees involved with outsourcing facilities and interested in the advancement of regulatory policy. Day three offers an introduction to the new path for pharmaceutical inspections in Europe and beyond through the U.S. FDA’s new Mutual Reliance Initiative and the much-anticipated “Ask the Regulators” panel session, where the audience can interact with highly regarded regulatory professionals and get answers to their most pressing microbial questions.

Molly O’Neill Moir, CMP PDA

The program will connect industry, academic, and regulatory professionals at all levels to achieve a unified goal of learning through sharing of best practices, development of standards, and integration of innovative technologies.

Brooke Schneider, CMP PDA

Please join us October 16-18 in Bethesda, MD for this always-popular interactive learning opportunity!

October 16-18, 2017 | Bethesda North Marriott Hotel & Conference Center | Bethesda, MD Exhibition: October 16-17 | 2017 PDA Endotoxins Workshop: October 18-19 | Courses: October 19-20

#PDAMicro

GENERAL INFORMATION, REGISTRATION For specific information on the 2017 PDA Endotoxins Workshop, turn to page 13.

FOUR WAYS TO REGISTER 1. Click 2. Fax 3. Mail 4. Phone

pda.org/2017Micro +1 (301) 986-1093 PDA Global Headquarters Bethesda Towers 4350 East West Highway, Suite 600 Bethesda, MD 20814 USA +1 (301) 656-5900 ext. 115

LEARNING OBJECTIVES At the completion of this Conference, participants will be able to: • Demonstrate increased knowledge in many areas of microbiology, including managing microbial risk and the dynamics of microbial contamination • Identify current trends in microbiology (new technologies) • Summarize new advances in rapid microbiological methods and updates in endotoxin testing • Describe the challenges posed by mold and spore contamination • Identify local regulatory and pharmacopeial expectations • Explain global harmonization plans

CONFERENCE REGISTRATION HOURS VENUE Bethesda North Marriott Hotel & Conference Center 5701 Marinelli Rd. North Bethesda, MD 20852 Phone: +1 (301) 822-9200 Website: www.bethesdanorthmarriott.com Rate: Single: $267, plus applicable state and local taxes. Cut-off Date: Monday, September 18 (Rooms must be secured by this date in order to receive the PDA rate.) Rates are guaranteed until the PDA block of rooms are sold out on a first-come basis.

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 mail 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. 12th Annual PDA Global Conference on Pharmaceutical Microbiology ACPE #: 0116-0000-17-024-L04-P | 1.7 CEUs Type of Activity: Knowledge

Sunday, October 15: 3:00 p.m. – 7:00 p.m. Monday, October 16: 7:00 a.m. – 5:30 p.m. Tuesday, October 17: 7:00 a.m. – 4:30 p.m. Wednesday, October 18: 7:00 a.m. – 12:30 p.m.

COURSE REGISTRATION HOURS Thursday, October 19: 7:30 a.m. – 4:00 p.m. Friday, October 20: 7:30 a.m. – 4:00 p.m. Please note, four of the courses will be held at the Bethesda North Marriott Hotel & Conference Center and one will be held at the PDA Training and Research Institute. Please see pages 19-21 for more information on each specific course offered as part of the the 12th Annual PDA Global Conference on Pharmaceutical Microbiology Course Series.

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

CONTACT INFORMATION Conference Inquiries Molly O’Neill Moir, CMP Vice President, Programs & Meetings Tel: +1 (301) 656-5900 ext. 132 Email: moir@pda.org Brooke Schneider, CMP Manager, Programs Tel: +1 (301) 656-5900 ext. 111 Email: schneider@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 Course Inquiries Stephanie Ko Senior Manager, Lecture Education Tel: +1 (301) 656-5900 ext. 151 Email: ko@pda.org

12TH ANNUAL PDA GLOBAL CONFERENCE ON PHARMACEUTICAL MICROBIOLOGY – GENERAL INFORMATION

12th Annual PDA Global Conference on Pharmaceutical Microbiology

12TH ANNUAL PDA GLOBAL CONFERENCE ON PHARMACEUTICAL MICROBIOLOGY – AGENDA

Connecting People, Science and Regulation®

SUNDAY, OCTOBER 15 3:00 p.m. – 7:00 p.m. Registration Open

MONDAY, OCTOBER 16 7:00 a.m. – 5:30 p.m. Registration Open 7:00 a.m. – 8:30 a.m. Continental Breakfast 8:15 a.m. – 8:30 a.m. Welcome and Opening Remarks from Conference Co-Chair Vinayak B. Pawar, PhD, Senior Review Microbiologist, CDER, FDA 8:30 a.m. – 9:30 a.m. P1: Opening Plenary Session Moderator: Vinayak B. Pawar, PhD, Senior Review Microbiologist, CDER, FDA Session Description: After achieving a dramatic triumph over infection in the 20th century with the introduction of antibacterial chemotherapy, the threat of bacterial diseases has resurged with the rise of antibacterial resistance. The Centers for Disease Control and Prevention (CDC) estimate that in the United States, more than two million people are sickened every year with antibiotic-resistant infections, with at least 23,000 dying as a result. The history and contributing factors to the rising trend of antibacterial resistance in the United States will be discussed, as well as recent successes and challenges in the development of novel antibacterial drugs. Efforts to facilitate the development of antibacterial drugs for serious or life-threatening illnesses will be highlighted, including new approaches to the design of clinical trials. 8:30 a.m. – 9:00 a.m. The Challenge of Antibacterial Resistance: Learned Lessons and New Directions Center for Drug Evaluation and Research, U.S. FDA Representative Invited 9:00 a.m. – 9:30 a.m. Question and Answers/Discussion

12TH ANNUAL PDA GLOBAL CONFERENCE ON PHARMACEUTICAL MICROBIOLOGY

Sponsorship and Exhibit Opportunities Available! PDA’s annual Global Conference on Pharmaceutical Microbiology is one of the most popular conferences of its kind, attracting an audience of both new and returning “movers and shakers” in the field. Get your product or service in front of these influential decision makers by exhibiting at or sponsoring the 12th Annual PDA Global Conference on Pharmaceutical Microbiology! Sponsor a refreshment break, luncheon, or the Networking Reception for maximum visibility to attendees. Opportunities for expanding brand recognition include sponsoring hotel keycards, tote bags, lanyards, and wireless internet service. Or, customize your promotional package to fit your company’s specific needs. For exhibit and/or sponsorship information, please contact: David Hall, Vice President, Sales | Phone: +1 (240) 688-4405 | Email: hall@pda.org Alison Caballero, Senior Coordinator, Sales | Phone: +1 (301) 656-5900 x 135 | Email: caballero@pda.org

October 16-18, 2017 | Bethesda North Marriott Hotel & Conference Center | Bethesda, MD Exhibition: October 16-17 | 2017 PDA Endotoxins Workshop: October 18-19 | Courses: October 19-20

#PDAMicro

MONDAY, OCTOBER 16 (CONTINUED) 9:15 a.m. – 7:00 p.m. Exhibit Hall Open 9:30 a.m. – 10:15 a.m. Refreshment Break and Poster Presentations in Exhibit Hall 10:15 a.m. – 12:15 p.m. A1: Microbial Control Moderator: Edward Tidswell, PhD, Executive Director, Sterile Quality Assurance, Merck & Co./Merck Sharp & Dohme

10:15 a.m. – 12:15 p.m. B1: Non-Sterile Moderator: Eric J. Ward, MBA, Director of Quality Assurance, Boston Analytical

Session Description: Bioburden and microbial contamination represent, and will continue to represent, significant challenges to the controlled manufacture of sterile and non-sterile drugs and delivery devices. Successful control, assuring the requisite endproduct microbial quality attributes, must be commensurate with the different fundamental challenges bioburden and adventitious microbial contamination represent. This session will share strategies and practical tools as well as techniques in microbial control.

Session Description: Manufacture of non-sterile products presents a very different set of challenges for the microbiology laboratory. These groups of products include a wide range of types and dosage forms, each with its own considerations. Control of the entire process, from raw materials to finished product and the production area, is necessary to ensure that the conditions are appropriate for the intended application. As such, proper risk management is an essential component of these systems to provide thorough understanding of the system, the associated risks and proper controls. This session will delve into current regulatory expectations and trends, evaluation of incoming materials and environmental control as a part of the overall production system for non-sterile products.

10:15 a.m. – 10:45 a.m. Case Study of Environmental Mold Isolation in a Controlled Manufacturing Facility Leslie Falco, Quality Assurance Microbial Control Lead, Pfizer Inc.

10:15 a.m. – 10:45 a.m. Microbial Impact Assessment Kim Bowers, Quality Control Manager Environmental Monitoring/ Microbiology, Shire

10:45 a.m. – 11:15 a.m. Case Studies on Microbial Contamination: Benefit of a Cross-Functional Team Investigation Walid El Azab, Ind. Ph., Manager, Technical Services, Life Sciences Formulated Chemistries, STERIS Corporation

10:45 a.m. – 11:15 a.m. Contamination Control in Non Sterile Manufacturing Patricia V. Mills Davis, MSc, Senior Manager, Microbiology Lab, Johnson & Johnson Consumer Inc.

11:15 a.m. – 11:45 a.m. Fungal Spore Excursions in Cleanrooms: Case Studies Jim Polarine, Jr., MA, Senior Technical Service Manager, STERIS Corporation 11:45 a.m. – 12:15 p.m. Questions and Answers/Discussion

11:15 a.m. – 11:45 a.m. Taming the Microbial Zoo: FDA’s Perspectives on Non-sterile Drug Products Erika A. Pfeiler, PhD, Microbiologist, CDER, FDA 11:45 a.m. – 12:15 p.m. Questions and Answers/Discussion

12:15 p.m. – 1:30 p.m. Exhibitor Roundtable Luncheon – Exhibitors will be seated at designated tables and will be available for informal discussion with attendees. Exhibit Hall will be closed during this time.

12TH ANNUAL PDA GLOBAL CONFERENCE ON PHARMACEUTICAL MICROBIOLOGY – AGENDA

12th Annual PDA Global Conference on Pharmaceutical Microbiology

12TH ANNUAL PDA GLOBAL CONFERENCE ON PHARMACEUTICAL MICROBIOLOGY – AGENDA

Connecting People, Science and Regulation®

MONDAY, OCTOBER 16 (CONTINUED) 1:30 p.m. – 3:30 p.m. A2: Combination Products Moderator: Vinayak B. Pawar, PhD, Senior Review Microbiologist, CDER, FDA

1:30 p.m. – 3:30 p.m. B2: Environmental Monitoring Moderator: Marsha Steed (Hardiman), Senior Consultant, ValSource, LLC

Session Description: The pharmaceutical industry faces many manufacturing challenges as a wide spectrum of regulated treatments are now identified as combination products (e.g., patches, pumps, inhalers, nasal vaccines, targeted nanoparticles, syringes, and other delivery methods). Attendees will hear from an industry representative about combination product delivery system design (e.g., an adequate cleanroom, support utilities, and equipment for manufacturing combination components) and manufacturing logistics, such as continuous manufacturing applications and flexible facility designs. Regulatory speakers will discuss strategies for demonstrating compliance with cGMP requirements, whether for each of the constituent parts or for the combination product as a whole, with case studies related to current combination product initiatives and updates.

Session Description: Environmental monitoring (EM) plays a critical role in our companies for all manufacturing types including non-sterile, low bioburden, medical devices, and aseptic processing. The industry is inundated with guidance about EM for aseptic processing operations, but there is a lack of guidance when it comes to low bioburden processes. This session will include an overview on a new PDA technical report, which will give guidance for low bioburden EM. It will cover EM trending advantages when using contamination recovery rates to understand your results. A look into single incubation with rapid technology will also be shown with a case study example.

1:30 p.m. – 2:00 p.m. Manufacturing Challenges Susan Neadle, MS, Head, Combination Products CoE and Senior Director, Design-to-Value and Product Quality Management, Johnson & Johnson Janssen Pharmaceuticals

1:30 p.m. – 2:00 p.m. Using Contamination Rates for Environmental Monitoring Trending Paula Peacos, MS, Associate Director of Microbiology, Global Pharmaceutical Quality, Bristol-Myers Squibb

2:00 p.m. – 2:30 p.m. Regulatory Challenges and Requirements for Combination Products: Current and Future Melissa B. Burns, MS, Policy Advisor, OC, FDA

2:00 p.m. – 2:30 p.m. Demonstrating Non-Inferiority for a Rapid, Automated Environmental Monitoring Technology Using a Single-Tiered Incubation Scheme Laure Singer, Senior Associate, Quality Assurance, Pfizer Inc.

2:30 p.m. – 3:00 p.m. Current Combination Product Initiatives and Updates: Case Studies Steven B. Hertz, MS, Consumer Safety Officer, CDER, FDA 3:00 p.m. – 3:30 p.m. Questions and Answers/Discussion

2:30 p.m. – 3:00 p.m. Low Bioburden Environmental Monitoring: PDA Technical Report Development Update Dona B. Reber, MEd, TR Team Member and Co-Author of Technical Report No. 13 (Revised): Fundamentals of an Environmental Monitoring Program 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

October 16-18, 2017 | Bethesda North Marriott Hotel & Conference Center | Bethesda, MD Exhibition: October 16-17 | 2017 PDA Endotoxins Workshop: October 18-19 | Courses: October 19-20

MONDAY, OCTOBER 16 – TUESDAY, OCTOBER 17

#PDAMicro

4:15 p.m. – 5:45 p.m. P2: Emerging Leaders Moderator: Michael J. Miller, PhD, President, Microbiology Consultants, LLC Session Description: Solving problems in the microbiology laboratory often requires collaboration between many individuals across multiple departments. In addition, laboratory microbiologists often have to work across lines of responsibilities to ensure that projects are completed with involvement from all impacted areas. This session will include three case studies of problem resolution or project implementation with teams of individuals from the front line of the microbiology laboratory. 4:15 p.m. – 4:35 p.m. Getting Your Product from Fill Line to Clinic (with a Little Help from your Friendly Neighborhood Microbiologist) Carly Krystopik, Associate Research Scientist II, Bristol-Myers Squibb 4:35 p.m. – 4:55 p.m. You Gotta Know When to Hold ‘Em: Microbial Challenge Testing and In-use Hold Times for Non-preserved, Sterile, Single-use Products Sarah Weiser, MS, Formulation Scientist, Pfizer Inc. 4:55 p.m. – 5:15 p.m. How Very Sterile This Johnny Is: The Conundrum of Sterility Testing a Terminally-Sterilized Biodegradable Implant Melissa Gulmezian-Sefer, PhD, Senior Scientist, SMPD Microbiology, Allergan Inc. 5:15 p.m. – 5:45 p.m. Questions and Answers/Discussion 5:45 p.m. – 7:00 p.m. Networking Reception in Exhibit Hall

TUESDAY, OCTOBER 17 7:00 a.m. – 4:30 p.m. Registration Open 7:00 a.m. – 8:15 a.m. Continental Breakfast 7:00 a.m. – 8:00 a.m. Breakfast Roundtable Moderator: Marsha Steed (Hardiman), Senior Consultant, ValSource, LLC Session Description: The breakfast round table sessions will capture the conference theme of collaboration by bringing together attendees to address some hot microbiology topics. Some of these topics may not yet have consensus in the industry so further discussion is warranted. These will be presented in an innovative point/counter-point format, with experts presenting advantages and disadvantages, and risks and benefits of key topics such as: data integrity in the Microbiology lab (multiple analysts reads on plates), incubation schemes for EM, and reaction to microbiological excursions in the critical Grade A environment. The sessions will include small group break out discussions on these and other topics to determine comments and collect feedback for the health authorities. Facilitators: Amy McDaniel, PhD, Director, Quality Assurance Operations, Pfizer Inc. Kim Sobien, Principal Sterility Assurance Engineer, PETNET Solutions/a Siemens Company Eric J. Ward, MBA, Quality Assurance Director, Boston Analytical, Inc.

12TH ANNUAL PDA GLOBAL CONFERENCE ON PHARMACEUTICAL MICROBIOLOGY – AGENDA

12th Annual PDA Global Conference on Pharmaceutical Microbiology

12TH ANNUAL PDA GLOBAL CONFERENCE ON PHARMACEUTICAL MICROBIOLOGY – AGENDA

Connecting People, Science and Regulation®

TUESDAY, OCTOBER 17 (CONTINUED) 8:15 a.m. – 9:15 a.m. P3: Patient Perspective Moderator: Kim Sobien, Principal Sterility Assurance Engineer, PETNET Solutions | A Siemens Company Session Description: As a reminder of the importance of our work as pharmaceutical microbiologists, we will hear directly from a patient who is also an industry microbiologist and has benefited from the pharmaceutical and medical device products that our companies manufacture. No one ever plans on becoming ill, but when it occurs, the patient relies on the quality, safety, efficacy, and sterility of the products we manufacture to aid in his or her recovery. This patient perspective talk will remind us why we do what we do for a living and will highlight the patient benefits received as a result of our good work. 8:15 a.m. – 9:00 a.m. When the Microbiologist Becomes the Patient Marsha Steed (Hardiman), Senior Consultant, ValSource, LLC 9:00 a.m. – 9:15 a.m. Questions and Answers/Discussion 9:00 a.m. – 4:15 p.m. Exhibit Hall Open 9:15 a.m. – 10:00 a.m. Refreshment Break, Poster Presentations, and Passport Raffle Drawing in Exhibit Hall 10:00 a.m. – 12:00 p.m. A3: Quality Management for the Lab Moderator: MaryEllen E. Usarzewicz, MS, Parenteral Manufacturing Support Lead, Analytical & Bioanalytical Operations, Microbiology, Bristol-Myers Squibb

10:00 a.m. – 12:00 p.m. B3: Innovation in Pharmaceutical Microbiology Moderator: Amy McDaniel, PhD, Director, Quality Assurance Operations, Pfizer Inc.

Session Description: In alignment with the Conference theme, this session will focus on the criticality of collaboration in a regulated microbiology environment. Microbiologists are called upon to participate in excursion investigations and to provide guidance proactively. Ensuring that microbiologists can educate and train colleagues within their organizations and help to assure that their input is understood is crucial. This session will provide information about a risk-based approach to assessing environmental monitoring and critical utilities excursions, insight into the collaborative efforts of FDA investigators working together to assess quality for our patients as well as a case study on how one organization implemented a shop floor program driving collaboration between microbiology quality control, operations, and quality assurance.

Session Description: This session will focus on innovations for the modern microbiology laboratory, with an emphasis on advancing the science of detecting microorganisms and the manner in which we analyze the data. Participants will learn about the need for online water bioburden systems and how a number of companies have established strategies for validating new water monitoring technologies. The results from PQ comparative studies will also be shared. We will also hear a case study on applying statistical analyses on microbiological data to support claims of equivalence and non-inferiority when comparing alternative methods to compendial methods. The presentation will walk through the statistical models in an easy-to-understand format followed by case studies on how to apply the models using actual data. The session will end with a regulatory overview of the state of rapid sterility testing by one of FDA’s leading experts on alternative microbiological methods. The current need for rapid sterility testing, regulatory enablers, and examples of successful validation case studies will be discussed.

10:00 a.m. – 10:30 a.m. Aseptic Observation Program: A Shop Floor Program that Engages Quality and Operations to Assure Good Aseptic Technique Lisa Sykes-Winstead, MBA, Director of Quality Operations, Sterile Network Lead, Merck & Co./Merck Sharp & Dohme

10:00 a.m. – 10:30 a.m. Implementation of Online Water Bioburden Analytical Systems Brian Termine, PE, Engineering Maintenance Manager, Associate Fellow, GlaxoSmithKline

October 16-18, 2017 | Bethesda North Marriott Hotel & Conference Center | Bethesda, MD Exhibition: October 16-17 | 2017 PDA Endotoxins Workshop: October 18-19 | Courses: October 19-20

#PDAMicro

TUESDAY, OCTOBER 17 (CONTINUED) A3: Quality Management for the Lab (continued)

B3: Innovation in Pharmaceutical Microbiology (continued)

10:30 a.m. – 11:00 a.m. Risk-Based Microbial Assessment Tool (R-MAT): A Novel Approach to Assessing Environmental and Critical Utilities Excursions Amanda Bishop McFarland, Consultant, ValSource, LLC

10:30 a.m. – 11:00 a.m. Case Studies on Selecting Statistical Approaches for the Validation of Alternative and Rapid Microbiological Methods Michael J. Miller, PhD, President, Microbiology Consultants, LLC

11:00 a.m. – 11:30 a.m. Collaborative Inspections: How Many Teams of U.S. FDA Investigators and Microbiologists Work Together to Evaluate Drug Manufacturing Quality Office of Regulatory Affairs, U.S. FDA Representative Invited 11:30 a.m. – 12:00 p.m. Questions and Answers/Discussion

11:00 a.m. – 11:30 a. m. Rapid Sterility Tests Center for Drug Evaluation and Research, U.S. FDA Representative Invited 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. 1:30 p.m. – 3:30 p.m. A4: Biotechnology Moderator: Walid El Azab, Ind. Ph., Manager, Technical Services, Life Sciences Formulated Chemistries, STERIS Corporation

1:30 p.m. – 3:30 p.m. B4: Data Integrity Moderator: Julie Barlasov, MBA, Associate Director, Quality Systems & Compliance Sterile Quality Assurance Center of Excellence, Merck & Co./Merck Sharp & Dohme

Session Description: Recent regulatory updates and technological and manufacturing developments are significantly influencing the biopharmaceutical industry. The industry is facing pressure to continuously challenge and improve its manufacturing processes to achieve regulatory compliance and deliver high-quality product. It is also expected to implement new technology to improve microbial control and faster response to avoid drug shortage. The goal of this session is to share different industry perspectives on how introduction of new technology, robust aseptic training, effective root cause investigation, and microbial control will support lean processes, faster lead time, improved return on investment, and regulatory compliance.

Session Description: Data integrity is one of the hottest topics in the pharmaceutical industry, including in the microbiology world. We encounter daily questions like: how do we record data, how do we assure that information is accurate and contemporaneous, what is the data life cycle, how do we stay in compliance, and what are regulators looking for? This session will examine the regulatory perspective, holistic management governance, data governance initiatives, how to prevent and detect data integrity risks, and case studies.

1:30 p.m. – 2:00 p.m. It Takes Two to Take Control (Microbial Control, That Is)! Ruth Varden, MSc, Director, Quality, Alexion Pharmaceuticals, Inc. Jane Wyatt, MSc, Director, Quality Control Ireland, Alexion Pharmaceuticals, Inc.

1:30 p.m. – 2:00 p.m. Current Regulatory Perspectives on Data Integrity Office of Regulatory Affairs, U.S. FDA Representative Invited

2:00 p.m. – 2:30 p.m. The Use of Environmental Monitoring Recovery Rates in Support of Bulk Biologic Manufacturing Jeanne Mateffy, Director Quality Services, Microbiology, Amgen Inc.

2:00 p.m. – 2:30 p.m. Combating Human Error Monica Cahilly, President/Consultant, Green Mountain Quality Assurance, LLC

12TH ANNUAL PDA GLOBAL CONFERENCE ON PHARMACEUTICAL MICROBIOLOGY – AGENDA

12th Annual PDA Global Conference on Pharmaceutical Microbiology

12TH ANNUAL PDA GLOBAL CONFERENCE ON PHARMACEUTICAL MICROBIOLOGY – AGENDA

Connecting People, Science and Regulation®

TUESDAY, OCTOBER 17 (CONTINUED) A4: Biotechnology (continued)

B4: Data Integrity (continued)

2:30 p.m. – 3:00 p.m. Knowledge to Improve Industry Representative Invited

2:30 p.m. – 3:00 p.m. Auditing Techniques to Reveal Data Integrity Problems in Microbiology laboratories Dennis E. Guilfoyle, PhD, MS, Senior Director, Microbiology & Analytical Regulatory Compliance, Johnson & Johnson Regulatory Compliance

3:00 p.m. – 3:30 p.m. Questions and Answers/Discussion

3:00 p.m. – 3:30 p.m. Questions and Answers/Discussion 3:30 p.m. – 4:15 p.m. Refreshment Break, Poster Presentations, and Passport Raffle Drawing in Exhibit Hall 4:15 p.m. – 6:00 p.m. P4: FDA Update on Human Drug Compounding: Regulatory Policy and Drug Quality Moderator: John W. Metcalfe, PhD, Quality Assessment Lead, Division of Microbiology Assessment, Office of Process and Facilities/Office of Pharmaceutical Quality, CDER, FDA Session Description: During this session, FDA will provide an update on the Agency’s regulation and oversight of human drug compounding since the passage of the 2013 Drug Quality and Security Act (DQSA), which established a new category of drug compounders called outsourcing facilities. FDA speakers will provide an overview of the Agency’s compounding oversight program and describe relevant policies. Participants will learn about FDA’s inspectional program for outsourcing facilities; quality standards, including current good manufacturing practice requirements, and insanitary conditions applicable to outsourcing facilities; and guidance documents and regulations that pertain to outsourcing facilities. The session is targeted to participants from all segments of the pharmaceutical industry and is especially applicable to those working in the newly established outsourcing facility arena. 4:15 p.m. – 4:35 p.m. Overview of FDA’s Compounding Program Julie A. Dohm, PhD, JD, Agency Lead on Compounding and Senior Scientific Advisor for Compounding, CDER, FDA 4:35 p.m. – 4:55 p.m. FDA Policies Relevant to Compounding Quality Sara Rothman, MPH, Senior Policy Advisor, Office of Unapproved Drugs and Labeling Compliance, Office of Compliance, CDER, FDA 4:55 p.m. – 5:15 p.m. FDA Inspections of Outsourcing Facilities Office of Regulatory Affairs, U.S. FDA Representative Invited 5:15 p.m. – 5:45 p.m. Understanding CGMP Requirements and Insanitary Conditions Ian F. Deveau, PhD, Chief, Global Compliance Branch 1, Division of Drug Quality I, Office of Manufacturing Quality, Office of Compliance, CDER, FDA 5:45 p.m. – 6:00 p.m. Questions and Answers/Discussion

October 16-18, 2017 | Bethesda North Marriott Hotel & Conference Center | Bethesda, MD Exhibition: October 16-17 | 2017 PDA Endotoxins Workshop: October 18-19 | Courses: October 19-20

#PDAMicro

WEDNESDAY, OCTOBER 18 7:00 a.m. – 12:30 p.m. Registration Open 7:00 a.m. – 8:15 a.m. Continental Breakfast 7:00 a.m. – 8:00 a.m. Breakfast Roundtable Report Out Moderator: Marsha Steed (Hardiman), Senior Consultant, ValSource, LLC

7:00 a.m. – 8:00 a.m. Microbiology/Environmental Monitoring Interest Group Moderator: Julie Barlasov, MBA, Associate Director, Quality Systems & Compliance Sterile Quality Assurance Center of Excellence, Merck & Co./Merck Sharp & Dohme

Session Description: This roundtable will include a report out and full audience discussions on the results of day 1 findings from the various small groups. Collaboration will help make us all more informed on how to tackle these issues back in our own companies.

Session Description: The Microbiology/Environmental Monitoring Interest Group addresses topics in pharmaceutical microbiology, rapid microbiology, environmental monitoring, and compendial issues.

Facilitators: Amy McDaniel, PhD, Director, Quality Assurance Operations, Pfizer Inc. Kim Sobien, Principal Sterility Assurance Engineer, PETNET Solutions/a Siemens Company Eric J. Ward, MBA, Quality Assurance Director, Boston Analytical, Inc.

8:15 a.m. – 9:30 a.m. P5: USP Updates Moderator: Radhakrishna S. Tirumalai, Principal Scientific Liaison, U.S. Pharmacopeial Convention Session Description: 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. 8:15 a.m. – 8:40 a.m. Current Activities of the USP Microbiology Expert Committee David Hussong, PhD, Microbiology and Regulatory Consultant, ValSource, LLC 8:40 a.m. – 9:05 a.m. Proposed Revisions to USP <1211> and <1222> Edward Tidswell, PhD, Executive Director, Sterile Quality Assurance, Merck & Co./Merck, Sharp & Dohme 9:05 a.m. – 9:30 a.m. Questions and Answers/Discussion

12TH ANNUAL PDA GLOBAL CONFERENCE ON PHARMACEUTICAL MICROBIOLOGY – AGENDA

12th Annual PDA Global Conference on Pharmaceutical Microbiology

12TH ANNUAL PDA GLOBAL CONFERENCE ON PHARMACEUTICAL MICROBIOLOGY – AGENDA

Connecting People, Science and Regulation®

WEDNESDAY, OCTOBER 18 (CONTINUED) 9:40 a.m. – 10:40 a.m. P6: The Mutual Reliance Initiative: A New Path for Pharmaceutical Inspections in Europe and beyond Moderator: CAPT Sharon K. Thoma, PharmD, National Expert of Pharmaceuticals, United States Public Health Service, ORA, FDA Session Description: The Mutual Reliance Initiative is a new path for Mutual Recognition Agreements between two or more countries to recognize a specific process or procedure of the other country. The intent is to create an expanded inspectorate, one where investigators and inspectors from FDA and trusted partners, such as those in the European Union and beyond, would work together, rely on each other’s inspections, avoid duplicating inspections, and conduct more inspections in areas where drug manufacturing has greatly increased. The benefit of Mutual Recognition is the strengthening of different countries using each other’s drug inspection expertise and resources, which will result in greater efficiencies for both regulatory systems and provide a more practical means for overseeing the large number of drug manufacturing facilities outside of the U.S. and EU. 9:40 a.m. – 10:10 a.m. FDA’s 2017 Mutual Reliance Initiative Office of Regulatory Affairs, U.S. FDA Representative Invited 10:10 a.m. – 10:40 a.m. Questions and Answers/Discussion 10:40 a.m. – 11:00 a.m. Refreshment Break 11:00 a.m. – 12:30 p.m. P7: Ask the Regulators Moderators: Kim Sobien, Principal Sterility Assurance Engineer, PETNET Solutions | A Siemens Company, and John W. Metcalfe, PhD, Quality Assessment Lead, Division of Microbiology Assessment, Office of Process and Facilities/Office of Pharmaceutical Quality, CDER, FDA Session Description: In the “Ask the Regulators” session, attendees can interact directly with members of regulatory agencies to pose questions and get answers about pressing microbiology issues. This session will provide attendees with a unique opportunity to engage several regulatory speakers in further discussions regarding regulations, trends, solutions, and best demonstrated practices. Panelists: Office of Regulatory Affairs, U.S. FDA Representative Invited Julie Dohm, PhD, JD, Agency Lead on Compounding and Senior Scientific Advisor for Compounding, CDER, FDA Lynne A. Ensor, PhD, Director, Division of Microbiology Assessment, CDER, FDA Laurie P. Norwood, Deputy Director, Office of Compliance and Biologics Quality, CBER, FDA 12:30 p.m. Closing Remarks from the Conference Co-Chair Kim Sobien, Principal Sterility Assurance Engineer, PETNET Solutions | A Siemens Company

October 19-20, 2017 | Bethesda, MD

12TH ANNUAL PDA GLOBAL CONFERENCE ON PHARMACEUTICAL MICROBIOLOGY COURSE SERIES – OCTOBER 19-20, 2017 Following the 12th Annual PDA Global Conference on Pharmaceutical Microbiology, PDA Education will offer five courses from October 19-20, 2017, designed to complement what you learned at the Conference. Four of the courses will be held at the Bethesda North Marriott Hotel & Conference Center and one will be held at the PDA Training and Research Institute. Please see the following pages for more information on each specific course offered as part of the the 12th Annual PDA Global Conference on Pharmaceutical Microbiology Course Series.

Continuing Education for Pharmacists

Continuing Education for Engineers

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 mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive CPE credit.

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.

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. Always submit CPE activity claims as soon as possible and by the deadline specified on the CPE credit request form.

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 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

Students who pre-register will now be given access to electronic course notes, which may be printed once approximately 1-2 weeks in advance for use during the course. Hard copies of course notes will no longer be provided to pre-registered students and only a limited number of hard copies will be available for onsite and transferring registrants on a first-come, first-served basis.

pda.org/2017MicroCS

12TH ANNUAL PDA GLOBAL CONFERENCE ON PHARMACEUTICAL MICROBIOLOGY COURSE SERIES

12th Annual PDA Global Conference on Pharmaceutical Microbiology Course Series

12TH ANNUAL PDA GLOBAL CONFERENCE ON PHARMACEUTICAL MICROBIOLOGY COURSE SERIES

Connecting People, Science and Regulation®

12TH ANNUAL PDA GLOBAL CONFERENCE ON PHARMACEUTICAL MICROBIOLOGY COURSE SERIES – OCTOBER 19-20, 2017 (CONTINUED) How to Use and Interpret Data for Particle Counters and Microbial Air Samplers – New Course Location: Date: Duration: Time:

Bethesda North Marriott Hotel & Conference Center | Bethesda, MD October 19, 2017 1 day 8:30 a.m. – 4:00 p.m.

Course Number: PDA #528 CPE: ACPE #0116-0000-17-004-L04-P | 0.6 CEUs Type of Activity: Application This course will enable participants to use and interpret data for particle counters and microbial air samplers in cleanrooms. Topics will include the impact of total particulates and microbial contamination in ISO 5 environments. Participants will also be able to set alert and action levels for total particle and microbial contamination based on collected data, prepare a trend analysis and annual report, and manage out of specifications.

WHO SHOULD ATTEND Managers in pharmaceutical production, quality assurance, microbiological laboratory, and maintenance and engineering will benefit from taking this course.

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

• Create data trends and data interpretation for total particulates in cleanroom air

• Create data trends and data interpretation for total microbial contamination in cleanroom air

• Manage Out of Specifications (OOS) • Set alert and action levels for total particulate and microbial levels in cleanroom air

FACULTY Gilberto Dalmaso, PhD, Global Aseptic Processes Development Manager, Particle Measuring Systems

Regulatory Aspects of Microbiology in a Non-Sterile Environment Location: Date: Duration: Time:

Bethesda North Marriott Hotel & Conference Center | Bethesda, MD October 19, 2017 1 day 8:30 a.m. – 4:00 p.m.

Course Number: PDA #221 CPE: ACPE #0116-0000-14-031-L04-P | 0.6 CEUs Type of Activity: Knowledge This course is designed to assist participants in determining when they are in regulatory compliance within a non-sterile environment. Non-sterile microbiology offers many challenging regulatory issues often not considered in aseptic manufacturing because the rules are minimal in comparison; these include handling and evaluation of non-sterile components, the environment, and final product. This course discusses various regulations and how they impact non-sterile manufacturing, such as the setting of specification, 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 intended for individuals in the manufacturing of pharmaceuticals, cosmetic products, and dietary substances that are not labeled as sterile. Sufficient background information will be provided to enable participants with minimal science background to benefit. Individuals in quality assurance/quality control, regulatory compliance, manufacturing, research and development, technology transfer, and project management will benefit from this course.

PREREQUISITES Individuals will benefit having a basic background in the sciences including biology (microbiology) or chemistry and having basic familiarity with various regulations to include: 21 CFR 211, FDA Guidance documents, EMA and Health Canada guidance, and/or ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients – ICH Harmonized Tripartite Guideline, November 2000.

October 19-20, 2017 | Bethesda, MD

12TH ANNUAL PDA GLOBAL CONFERENCE ON PHARMACEUTICAL MICROBIOLOGY COURSE SERIES – OCTOBER 19-20, 2017 (CONTINUED) LEARNING OBJECTIVES

WHO SHOULD ATTEND

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

This course is intended for for professionals who are responsible for the identification of mold contaminants of finished product, raw materials or the manufacturing environment. Typical areas and roles include the following:

• 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 Non-Sterile Drug Substances and Products, complements the development of non-sterile products

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

• Quality Control: Microbiologists, Supervisors • Quality Assurance: Specialists, Supervisors Participants should have a basic understanding of microbiology.

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

• Identify common environmental isolates of molds to the Genus level and, for some isolates, to the species level

• Recognize proper terminologies for both macroscopic and microscopic images of molds

• Recommend isolation techniques appropriate for identification

Mold Identification for Quality Control Location: PDA Training and Research Institute | Bethesda, MD 4350 East West Highway, Suite 150 Bethesda, MD 21043 Dates: October 19-20, 2017 Duration: 2 days Time: 8:30 a.m. – 4:00 p.m. Course Number: PDA #803 CPE: ACPE #0116-0000-17-002-L04-P | 1.2 CEUs Type of Activity: Application This interactive course will give participants an opportunity to identify environmental isolates of mold using both macroscopic and microscopic techniques. Hands-on exercises will include Genus and species identification for many common, environmental mold contaminants that can be found in routine testing. This course will also include risk assessment for mold contamination, methods used to avoid mold contamination, preservation of mold specimens, rapid methods, and SOPs for mold identification. Participants will be given an opportunity to record observations of the morphology of numerous species growing on several types of media. Participants will receive a free copy of the book, “Medical Mycology: A Self-Instructional Text,” by Martha E. Kern as well as copies of photomicrographs of common environmental molds.

of mold

• Use several different techniques to identify unknown mold isolates • Locate potential sources of mold contamination and determine how to eliminate the source

• Design an in-house mold culture collection system • Prepare an SOP specific for identification of molds • Discuss the pros and cons for rapid methods of identification of molds

• Recognize appropriate reference books for mold identification • Train colleagues on the methods used for mold identification FACULTY John Brecker, Consultant

Application of Quality by Design and ICH Q9 Rules to Aseptic Processes and their Impact to Sterility Assurance – New Course Location: Date: Duration: Time:

Bethesda North Marriott Hotel & Conference Center | Bethesda, MD October 20, 2017 1 day 8:30 a.m. – 4:00 p.m.

Course Number: PDA #452 CPE: ACPE #0116-0000-17-005-L04-P | 0.6 CEUs Type of Activity: Application This course will enable participants to better use and interpret the ICH Q9 and QbD Guidelines for application in aseptic processes. Participants will learn to design and analyze their aseptic processes while considering the risk points and their management. They will also understand the impact of and possibilities offered by the QbD Guideline to improve their aseptic processes.

pda.org/2017MicroCS

12TH ANNUAL PDA GLOBAL CONFERENCE ON PHARMACEUTICAL MICROBIOLOGY COURSE SERIES

12th Annual PDA Global Conference on Pharmaceutical Microbiology Course Series

12TH ANNUAL PDA GLOBAL CONFERENCE ON PHARMACEUTICAL MICROBIOLOGY COURSE SERIES

Connecting People, Science and Regulation®

12TH ANNUAL PDA GLOBAL CONFERENCE ON PHARMACEUTICAL MICROBIOLOGY COURSE SERIES – OCTOBER 19-20, 2017 (CONTINUED) WHO SHOULD ATTEND

LEARNING OBJECTIVES

Managers in pharmaceutical production, quality assurance, microbiological laboratory, and maintenance and engineering will benefit from this course.

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

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

• • • •

Apply quality by design (QbD) guidelines to aseptic processes Interpret the application of ICH Q9 Apply risk management for aseptic processes Design an aseptic process based on QbD

• Discuss the principles and best practices of microbial control in • • •

FACULTY Paola Lazzeri, GMP Specialist, Particle Measuring Systems

•

Bioburden and Biofilm Management Location: Date: Duration: Time:

Bethesda North Marriott Hotel & Conference Center | Bethesda, MD October 20, 2017 1 day 8:30 a.m. – 4:00 p.m.

Course Number: PDA #476 CPE: ACPE #0116-0000-16-051-L04-P | 0.6 CEUs Type of Activity: Knowledge This course will provide scientific understanding and real-world practices for the management of bioburden and biofilm in pharmaceutical and biopharmaceutical production processes. Microbial control of pharmaceutical API and biopharmaceutical drug substances or API production processes is a significant quality and compliance problem today.

WHO SHOULD ATTEND This course is intended for scientists and technical staff, middle- to senior-level managers in pharmaceutical and biopharmaceutical quality control, quality assurance, regulatory affairs, manufacturing, and development.

•

pharmaceutical processes based on current best practices and regulatory expectations Explain the biology underlying bioburden development in pharmaceutical and biopharmaceutical drug substance production systems Explain the mechanisms surrounding biofilm formation and the complex interactions that exist between planktonic and sessile modes of microbial contamination Provide information on typical control levels/limits for various types and stages of biopharmaceutical production systems, including critical utility systems Discuss principles and best practices in prevention, detection, and remediation of microbial contamination in pharmaceutical/ biopharmaceutical drug substance or API production systems, including current regulatory guidance and expectations Manage microbial quality issues and conduct effective investigations, remediation, and regulatory interactions

FACULTY Marc Mittelman, Principal, Mittelman & Associates, LLC

12th Annual PDA Global Conference on Pharmaceutical Microbiology (Oct. 16-18) and 2017 PDA Endotoxins Workshop: (Oct. 18-19) Bethesda North Marriott Hotel & Conference Center | Bethesda, MD Exhibition: Oct. 16-17 | Post-Workshop: Oct. 18-19 | Courses: Oct. 19-20

Four easy ways to register – Click: www.pda.org/2017Micro Fax: +1 (301) 986-1093 (U.S.A.) Mail: PDA Global Headquarters 4350 East West Highway, Suite 600 Bethesda, MD 20814 U.S.A. Call: +1 (301) 656-5900 ext. 115

PDA Membership Number Prefix First Name Last Name Job Title Company Business Address City State/Province ZIP+4/Postal Code Country Email Business Phone Fax  Substituting for

1 Contact Information

(Check only if you are substituting for a previously enrolled colleague. The fee difference in the prevailing rate is due at the time of substitution. Please note that if you are a non-member substituting for a member, you will be required to pay the difference in the non-member fee.)

Package | CONFERENCE & WORKSHOP Registration | 2 Premiere October 16-19 Please check appropriate fee (US$).

Special Dietary Requirements (Please be specific):

Save up to $750 Before Aug. 4, 2017 Aug. 4 – Sept. 5, 2017 After Sept. 5, 2017

Member  $ 3,340  $ 3,790  $ 4,240

Non-member  $ 3,819  $ 4,269  $ 4,719

 Check here to become a member and receive the member price for this event. (Add $279 to your total.)

CONFERENCE Registration | October 16-18 3 Please check appropriate fee (US$). PDA Member Non-member

Before Aug. 4, 2017  $ 1,995  $ 2,274

Aug. 4 – Sept. 5, 2017  $ 2,395  $ 2,674

After Sept. 5, 2017  $ 2,595  $ 2,874

 $ 700  $ 800

Government/Health Authority

Member Non-member* Academic

Member Non-member*

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.

COURSE Registration | October 19-20 5 Please check appropriate fee (US$). PDA #221 PDA #528 PDA #803 PDA #452

Regulatory Aspects of Microbiology in a Non-Sterile Environment (October 19) How to Use and Interpret Data for Particle Counter and Microbial Air Samplers (October 19) Mold Identification for Quality Control (October 19-20) Application of Quality by Design and ICH Q9 Rules to Aseptic Processes and their Impact to Sterility Assurance (October 20) PDA #476 Bioburden and Biofilm Management (October 20)

Course #221

Student

Member  $ 280  $ 280  $ 280 Non-member*  $ 310  $ 310  $ 310 * For this member type or discounted rate, online registration is not available and must be faxed in.

4 2017 PDA Endotoxins Workshop | WORKSHOP Registration | October 18-19 Please check appropriate fee (US$).

Government/ Health Authority

PDA Member Non-member Member Non-member*

Academic

Member Non-member*

Student

Member Non-member*

6 Payment Options

On or before Sept. 5, 2017  $ 1,495  $ 1,695  $ 700  $ 800  $ 700  $ 800  $ 280  $ 310

All cards are charged in US$.

After Sept. 5, 2017  $ 1,695  $ 1,895  $ 700  $ 800  $ 700  $ 800  $ 280  $ 310

Course #528

Course #803

Course #452

Course #476

On or before Sept. 4, 2017 Standard

 $ 1,169  $ 1,169  $ 2,419  $ 1,169  $ 1,169  $ 1,403  $ 1,403  $ 2,915  $ 1,403  $ 1,403

Member Non-member Government/Health Authority/Academic

Member/Non-member* After Sept. 4, 2017 Standard

 $ 779

 $ 1,619  $ 779

 $ 779

 $ 1,299  $ 1,299  $ 2,699  $ 1,299  $ 1,299  $ 1,559  $ 1,559  $ 3,239  $ 1,559  $ 1,559

Member Non-member Government/Health Authority/Academic

 $ 779

Member/Non-member*

 $ 779

 $ 1,619  $ 779

 $ 779

Have a Campaign Code?

Group Registration: Register 4 people from the same organization as a group (at the same time) for the CONFERENCE and receive the 5th registration free. Other discounts cannot be applied. All forms MUST be faxed in together.

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 Country 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 cancelation notice is not received by August 17, 2017, your credit card will be charged the prevailing rate. SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including on-site at the prevailing rate. 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 17, 2017, 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 PHOTO ID WILL BE REQUIRED IN ORDER TO PICK UP BADGE MATERIALS ON-SITE. 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 19, 2017, 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/PHOTO RELEASE: By registering for these events, I authorize PDA to record and photograph me and to use the recordings/photographs in all formats and media for any purpose, including for education, marketing and trade purposes. I hereby release PDA from all claims arising out of the use of the recordings/photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership. Tape recordings are prohibited at all PDA Conferences.

PDA USE ONLY Date:

Check:

Amount:

Account:

101617B