Monday, October 16
7:00 a.m. – 5:30 p.m.
Registration Open
7:30 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
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8:30 a.m. – 9:30 a.m.
P1: Opening Plenary Session
Moderator: Vinayak B. Pawar, PhD, Senior Review Microbiologist, CDER, FDA
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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.
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8:30 a.m. – 9:00 a.m.
The Challenge of Antibacterial Resistance: Learned Lessons and New Directions
Edward A. Weinstein, MD, PhD, Medical Officer, CDER, FDA
9:00 a.m. – 9:30 a.m.
Questions and Answers/Discussion
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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 Area
10:15 a.m. – 12:15 p.m.
Concurrent Sessions
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A1: Microbial Control
Moderator: Edward Tidswell, PhD, Executive Director, Sterile Quality Assurance, Merck & Co./Merck Sharp & Dohme
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Session Description: Bioburden and microbial contamination represent, and will continue to represent, significant challenges to the controlled manufacture of sterile, non-sterile drugs and devices. Successful control assuring the requisite end product 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.
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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.
10:45 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
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
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B1: Non-Sterile
Moderator: Eric J. Ward, MBA, Quality Assurance Director, Boston Analytical, Inc.
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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.
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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.
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.
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
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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.
1:30 p.m. – 3:30 p.m.
Concurrent Sessions
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A2: Combination Products
Moderator: Vinayak B. Pawar, PhD, Senior Review Microbiologist, CDER, FDA
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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 the industry representative about combination product delivery system design (e.g., 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 requirement, 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.
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1:30 p.m. – 2:00 p.m.
Manufacturing Challenges
Susan Neadle, MS, Head, Combination Products Center of Excellence and Senior Director, Design-to-Value and Product Quality Management, Johnson & Johnson Janssen Pharmaceuticals
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
2:30 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
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B2: Environmental Monitoring
Moderator: Marsha Steed (Hardiman), Senior Consultant, Valsource, LLC
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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.
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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.
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.
Low Bioburden Environmental Monitoring: PDA Technical Report Development Update
Dona B. Reber, MEd, Technical Report 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
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3:30 p.m. – 4:15 p.m.
Refreshment Break and Poster Presentations in Exhibit Hall
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4:15 p.m. – 5:45 p.m.
P2: Emerging Leaders
Moderator: Michael J. Miller, PhD, President, Microbiology Consultants, LLC
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Session Description: Solving problems in the microbiology laboratory often requires collaboration between many individuals and 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.
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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
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5:45 p.m. – 7:00 p.m.
Networking Reception in Exhibit Area
Tuesday, October 17
7:00 a.m. – 4:30 p.m.
Registration Open
7:00 a.m. – 8:15 a.m.
Continental Breakfast
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7:00 a.m. – 8:00 a.m.
Breakfast Roundtable
Moderator: Marsha Steed (Hardiman), Senior Consultant, ValSource, LLC
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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.
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8:15 a.m. – 9:15 a.m.
P3: Patient Perspective
Moderator: Kim Sobien, Principal Sterility Assurance Engineer, PETNET Solutions | A Siemens Company
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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, who has benefited from the pharmaceutical and medical device products that our companies manufacture. No one ever plans on becoming ill; but when it happens to someone, that patient relies on the quality, safety, efficacy, and sterility of the products we manufacture in our jobs to aid in their recovery. This patient perspective talk will remind us why we do what we do for a living and will bring together the patient benefits received as a result of our good work.
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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
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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 in Exhibit Hall
10:00 a.m. – 12:00 p.m.
Concurrent Sessions
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A3: Quality Management for the Lab
Moderator: MaryEllen E. Usarzewicz, MS, Parenteral Manufacturing Support Lead, Analytical & Bioanalytical Operations, Microbiology, Bristol-Myers Squibb
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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.
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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
10:30 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
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
U.S. FDA ORA Representative Invited
11:30 a.m. – 12:00 p.m.
Questions and Answers/Discussion
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B3: Innovation in Pharmaceutical Microbiology
Moderator: Amy McDaniel, PhD, Director, Quality Assurance Operations, Pfizer Inc.
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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.
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10:00 a.m. – 10:30 a.m.
Towards a New Paradigm for Compendial Sterility Testing
Anthony M. Cundell, PhD, Consulting Microbiologist, Microbiological Consulting, 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.
Rapid Sterility Tests
Bryan S. Riley, PhD, Branch Chief (Acting), Division of Microbiology Assessment Branch II, CDER, FDA
11:30 a.m. – 12:00 p.m.
Questions and Answers/Discussion
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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.
Concurrent Sessions
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A4: Biotechnology
Moderator: Walid El Azab, Ind. Ph., Manager, Technical Services, Life Sciences Formulated Chemistries, STERIS Corporation
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Session Description: Recent regulatory updates and technological and manufacturing developments are significantly influencing the biopharmaceutical industry. The biopharmaceutical industry is facing pressure to continuously challenge and improve their manufacturing processes to achieve regulatory compliance and high quality product. In addition, 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.
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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.
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.
2:30 p.m. – 3:00 p.m.
A Risk-Based Approach for an Aseptic Manipulation and Intervention Program
Frederic B. Ayers, Consultant Scientist - Sterility Assurance Technology, Eli Lilly and Company
3:00 p.m. – 3:30 p.m.
Questions and Answers/Discussion
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B4: Data Integrity
Moderator: Julie Barlasov, MBA, Associate Director, Sterile and Microbiology Quality Assurance Center of Excellence, Merck & Co./Merck Sharp & Dohme
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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.
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1:30 p.m. – 2:00 p.m.
Current Regulatory Perspectives on Data Integrity
Paula Katz, JD, Director, Manufacturing Quality Guidance and Policy, CDER, FDA
2:00 p.m. – 2:30 p.m.
Combating Human Error
Monica Cahilly, MS, President/Consultant, Green Mountain Quality Assurance, LLC
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
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3:30 p.m. – 4:15 p.m.
Refreshment Break, Poster Presentations, and Passport Raffle in Exhibit Hall
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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
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Session Description: During this session, FDA will provide an update on the Agency’s regulation and oversight of human drug compounding since 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.
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4:15 p.m. – 4:35 p.m.
Overview of FDA’s Compounding Program
Julie 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
Justine Tomasso, MBS, Consumer Safety Officer, Pharmaceutical Quality Programs Branch, Division of Pharmaceutical Quality Programs/Office of Pharmaceutical Quality Operations, ORA, FDA
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.A
Questions and Answers/Discussion
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Wednesday, October 18
7:00 a.m. – 12:30 p.m.
Registration Open
7:00 a.m. – 8:15 a.m.
Continental Breakfast
7:15 a.m. – 8:15 a.m.
Concurrent Breakfast Sessions
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Breakfast Roundtable Report Out
Moderator: Marsha Steed (Hardiman), Senior Consultant, Valsource, LLC
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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.
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.
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Microbiology/Environmental Monitoring Interest Group
Moderator: Julie Barlasov, MBA, Associate Director, Sterile and Microbiology Quality Assurance Center of Excellence, Merck & Co./Merck Sharp & Dohme
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| Session Description: The Microbiology/Environmental Monitoring Interest Group addresses topics in pharmaceutical microbiology, rapid microbiology, environmental monitoring, and compendial issues. |
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8:15 a.m. – 9:30 a.m.
P5: USP Updates
Moderator: Radhakrishna Tirumalai, Principal Scientific Liaison, U.S. Pharmacopeial Convention
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Session Description: Compatible with its overall mission, the role of the 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.
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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
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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
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Session Description: 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 the increase in drug manufacturing has greatly increased. The benefit of Mutual Recognition is in strengthening the use of each other’s drug inspection expertise and resources which will result in greater efficiencies for both regulatory systems and provide a more practical means to oversee the large number of drug manufacturing facilities outside of the U.S. and EU.
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9:40 a.m. – 10:10 a.m.
FDA's 2017 Mutual Reliance Initiative
Susan F. Laska, Senior Advisor for Medical Products, ORA, FDA
10:10 a.m. – 10:40 a.m.
Questions and Answers/Discussion
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10:40 a.m. – 11:00 a.m.
Refreshment Break
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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
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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.
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Panelists
U.S. FDA ORA Representative Invited
U.S. FDA CDRH 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
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12:30 p.m.
Closing Remarks from the Conference Co-Chair
Kim Sobien, Principal Sterility Assurance Engineer, PETNET Solutions | A Siemens Company