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12th Annual PDA Global Conference on Pharmaceutical Microbiology

Oct 16 - Oct 18, 2017
Bethesda, MD

Solving Microbiological Challenges and Sustaining Success through a Culture of Collaboration

  • Conference
  • The Americas
Program Highlights

Through presentations, breakout sessions, and case studies, Conference sessions will address:

  • FDA Update on Human Drug Compounding: Regulatory Policy and Drug Quality
  • USP Updates
  • The Mutual Reliance Initiative: A New Path for Pharmaceutical Inspections in Europe and Beyond
  • Emerging Leaders in Microbiology

Overview

The 12th Annual PDA Global Conference on Pharmaceutical Microbiology is designed to meet the unique needs of pharmaceutical microbiologists and interdisciplinary scientists involved in manufacturing and regulating the pharmaceutical industry. It also provides excellent opportunities to network, interact, and share with and learn from industry experts and professionals from around the world.

This “best in class” Conference will feature an exciting agenda that encompasses a wide variety of issues pharmaceutical microbiologists face and work in partnership to solve daily. A theme of collaboration is woven throughout the Conference, focusing on how we work together to solve highly complex problems and develop novel, compliant, and robust solutions to ensure products are of the highest quality for patients. The “Ask the Experts” interactive session returns by popular demand!

Hear presentations at concurrent sessions from global regulatory and industry experts who will share recent case studies and current trends in the field of pharmaceutical microbiology. Hot topics include:

 

  • Quality Management for the Microbiology Laboratory
  • Updates from USP
  • Innovation in Pharmaceutical Microbiology
  • Data Integrity – Current Regulatory Perspective
  • Manufacturing Challenges – The Future of Biotech

In addition, PDA will host an exhibition of leading bio/pharmaceutical companies who will showcase new technologies and trends for pharmaceutical microbiology strategies. And don’t miss the poster presentations highlighting the latest research and developments in this exciting field! Lunch, refreshment breaks, and the Networking Reception will provide a relaxed environment to view posters, visit vendors, and interact with others to discuss topics from the day’s presentations.

Attend this Conference for the unique opportunity to contribute to future advancements in pharmaceutical microbiology.

Contact

Brooke Schneider, CMP
Manager, Programs
Tel: (301) 656-5900 ext. 111
Email: [email protected]

Registration Customer Care
Tel: +1 (301) 656-5900 ext. 115
Email: [email protected]

Exhibition Inquiries
David Hall
Vice President, Sales 
Tel: +1 (240) 688- 4405
Email: [email protected]

Course Inquiries
Stephanie Ko
Senior Manager, Lecture Education 
Tel: +1 (301) 656-5900 ext. 151
Email: [email protected]

Agenda

  • Monday, October 16

    7:00 a.m. – 5:30 p.m.
    Registration Open

    7:00 a.m. – 8:00 a.m.
    PDA Orientation Breakfast (Invitation Only) 

    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
    Edward A. Weinstein, MD, PhD, Medical Officer, CDER, FDA

    9:00 a.m. – 9:30 a.m.
    Questions and Answers/Discussion

    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

    POSTER PRESENTATIONS
    The following posters will be presented during Monday’s refreshment breaks.

    1. Implementation of the Growth Direct™ System: Driving for Greater Accuracy, Speed, and Efficiency in Microbial Enumeration
    Ashley Durusky, Senior Supervisor QC Microbiology, Biogen

    2. Comparison of Microbial Identification Methods and the Operational Impact in a Drug Quality Control Laboratory in Costa Rica
    Franklin Binns,
    Pharmacist, Microbiología Farmacéutica

    3. Discovery of Matrix Interference with an In-Process Production Sample During Method Validation for Endotoxin (LAL): A Case Study
    Jennifer Bachner,
    QC Scientist IV, Pfizer Inc.

    4. The Impact of Disposables on Limulus Amebocyte Lysate (LAL) Based Assays and Endotoxin Hold Time Studies
    John Brooks,
    Technical Services Representative, Associates of Cape Cod Inc.

    5. Mechanisms of Hidden Endotoxin in Biologic Drug Process Preparations
    Kevin Williams,
    Senior Scientist, bioMérieux, Inc.

    6. An LER Case Study for Monoclonal Antibody Drug Product
    Lin Chen, PhD,
    Principal Scientist, Pfizer Inc.

    7. Optimization of Data Interpretation Criteria (i.e., Score Cutoffs for Species Confidence) for Bacterial and Yeast Identification Using MALDI-TOF Mass Spectrometry
    Prasanna Khot, PhD,
    Senior Staff Scientist, Charles River Laboratories

    8. Recurring Microbial Contamination Disrupts the Cost-Time-Quality Balance: A Case Study 
    Joseph McCall
    , Technical Services Specialist, Life Sciences Formulated Chemistries, STERIS Corporation

    9. Evaluation of the New EviSight™ Compact System for the Growth Promotion Testing of Culture Media Used for Water Testing and Environmental Monitoring Using Pharmacopeial Strains and Wild Strain Isolates
    Susan McDonagh,
    QC Analyst, Pfizer Inc.

    10. BacT/ALERT as an Alternative Sterility Testing Method of a Cell Therapy Product
    Leela Rudrappa,
    Senior Microbiologist, Kita Pharma

    10:15 a.m. – 12:15 p.m.
    Concurrent Sessions

    A1: Microbial Control
    Moderator: Edward Tidswell, PhD, Executive Director, Sterile Quality Assurance, Merck & Co./Merck Sharp & Dohme

    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.

    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

    B1: Non-Sterile
    Moderator: Eric J. Ward, MBA, Quality Assurance Director, Boston Analytical, Inc.

    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.
    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

    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

    A2: Combination Products
    Moderator: Vinayak B. Pawar, PhD, Senior Review Microbiologist, CDER, FDA

    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.

    1:30 p.m. – 2:00 p.m.
    Manufacturing Challenges for Combination Products
    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

    B2: Environmental Monitoring
    Moderator: Marsha Steed (Hardiman), Senior Consultant, Valsource, LLC

    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.
    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 Equivalence 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

    3:30 p.m. – 4:15 p.m.
    Refreshment Break and Poster Presentations in Exhibit Hall

    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 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.

    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 Area

    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, hosted by the Microbiology/Environmental Monitoring Interest Group
    Moderators: Julie Barlasov, MBA, Associate Director, Sterile and Microbiology Quality Assurance Center of Excellence, Merck & Co./Merck Sharp & Dohme and Marsha Steed (Hardiman), Senior Consultant, ValSource, LLC

    Session Description: All conference attendees are welcome to participate in this breakfast roundtable. This session 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 environmental monitoring (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:
    Walid El Azab, Ind. Ph., Manager, Technical Services, Life Sciences Formulated Chemistries, STERIS Corporation
    Amy L. McDaniel, PhD, Microbiologist, CDER, FDA
    Kim Sobien, Principal Sterility Assurance Engineer, PETNET Solutions | a Siemens Company
    Wendy G. Tan, PhD, Microbiologist, CDER, FDA
    Eric J. Ward, MBA, Quality Assurance Director, Boston Analytical, Inc.

    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, 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.

    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 in Exhibit Hall

    POSTER PRESENTATIONS
    The following posters will be presented during Tuesday’s refreshment breaks.

    1. Parameters for Consideration in the Selection of Microspheres Used to Calibrate and Assess Online Water Bioburden Analyzer System Performance
    Allison Scott, PhD,
    Senior Applications Engineer, Azbil North America Research and Development - BioVigilant

    2. Validation Results of Nine Different Test Strains Using EZ-Fit™ Filtration Units and Performance Comparison Including Evaluation of Microbiological Recovery of Aspergillus Brasiliensis According to International Standards (US/EP/JP) Using Ten Membrane Filter Products
    Claire Fritz Briglia, Technology Specialist, EMD Millipore Corp.

    3. Upstream Biosafety: Using Nanofiltration to Prevent Virus and Microbial Contamination of Cell Culture Processes
    Corinne Miller, PhD,
    R&D Manager, MilliporeSigma

    4. Cleaning and Disinfection of Bacillus Cereus Biofilm
    Jim Polarine Jr., MA,
    Senior Technical Service Manager, STERIS Corporation

    5. The effect of Gamma Irradiation Process Interruption on Microbial Resistance of G. Stearothermophilus
    Fatima Hasanain,
    Polymer Materials Specialist, Nordion Inc.

    6. Data-Based Mechanism of Low Endotoxin Recovery
    Masakazu Tsuchiya,
    Senior Research Scientist, Charles River Laboratories

    7. Development of R2A Media Optimized for Pharmaceutical Grade Water and Evaluation of Automated Water Testing Using the EviSight™ Compact
    Lori Daane,
    Pharma Microbiology Scientific Director, bioMérieux, Inc.

    8. Environmental Control and Maintenance in the Manufacturing of Non-Sterile Drug Products: Kansai Study Group (KSG) of the PDA Japan Chapter
    Keisuke Inoue
    , Associate Director, Analytical Development Pharmaceutical Sciences, Takeda Pharmaceutical Company Limited

    10:00 a.m. – 12:00 p.m.
    Concurrent Sessions

    A3: Quality Management for the Lab
    Moderator: MaryEllen E. Usarzewicz, MS, Parenteral Manufacturing Support Lead, Analytical & Bioanalytical Operations, Microbiology, Bristol-Myers Squibb

    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.

    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
    Jennifer M. Gogley, Pharmaceutical Microbiologist, ORA, FDA 

    11:30 a.m. – 12:00 p.m.
    Questions and Answers/Discussion

    B3: Innovation in Pharmaceutical Microbiology
    Moderator: Amy L. McDaniel, PhD, Microbiologist, CDER, FDA

    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 way we analyze the data. Participants will learn about USP’s drive to develop the next generation in sterility testing. We will hear about a recent stimuli article on this topic and the work being done to generate a monograph chapter in support of this goal. 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.
    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

    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

    A4: Biotechnology
    Moderator: Walid El Azab, Ind. Ph., Manager, Technical Services, Life Sciences Formulated Chemistries, STERIS Corporation

    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.

    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

    B4: Data Integrity
    Moderator: Julie Barlasov, MBA, Associate Director, Sterile and Microbiology Quality Assurance Center of Excellence, Merck & Co./Merck Sharp & Dohme

    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.
    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

    3:30 p.m. – 4:15 p.m.
    Refreshment Break, Poster Presentations, and Passport Raffle 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 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 Dohm, PhD, JD, Agency Lead on Compounding and Senior Scientific Advisor for Compounding, CDER, FDA

    4:35 p.m. – 4:55 p.m.
    Policies Applicable to Outsourcing Facilities
    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

    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, hosted by the Microbiology/Environmental Monitoring Interest Group
    Moderators: Julie Barlasov, MBA, Associate Director, Sterile and Microbiology Quality Assurance Center of Excellence, Merck & Co./Merck Sharp & Dohme and Marsha Steed (Hardiman), Senior Consultant, ValSource, LLC

    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:
    Walid El Azab, Ind. Ph., Manager, Technical Services, Life Sciences Formulated Chemistries, STERIS Corporation
    Amy L. McDaniel, PhD, Microbiologist, CDER, FDA
    Kim Sobien, Principal Sterility Assurance Engineer, PETNET Solutions | a Siemens Company
    Wendy G. Tan, PhD, Microbiologist, CDER, FDA
    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, PhD, Principal Scientific Liaison, U.S. Pharmacopeial Convention

    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.

    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

    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: 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.

    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

    10:40 a.m. – 11:00 a.m.
    Refreshment Break

    11:00 a.m. – 12:30 p.m.
    P7: Closing Plenary: 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
    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

    12:30 p.m.
    Closing Remarks from the Conference Co-Chair
    Kim Sobien, Principal Sterility Assurance Engineer, PETNET Solutions | A Siemens Company

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE 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 Continuing Pharmacy Education credit, which will be awarded as follows:


    Type of Activity:

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (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. For more information, please visit the ACPE or NABP website.

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Virtual Attendance

Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

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  • Amenities

How to Get Here

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Registration Fees

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

† You must be a member to receive this rate.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

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If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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SUBSTITUTION: If a substitution request is sent by , no fee will be charged. After , a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent by , a full refund will be given minus a $200 fee. After , no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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