PDA Alternative Microbiological Methods Workshop 2024

Sunsetting Traditions: The Dawn of Applying and Embracing Change

Washington, DC
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Traditional microbiological test methods may not meet the turnaround time required to release the critical therapies needed by patients based on the rise in novel and compounded therapies.

The EU GMP Annex 1 revision and the recently proposed USP Pharmacopeial Forum draft chapters stress the importance of incorporating alternative microbiological methods in process/facility monitoring and release test methods.

Learn how to successfully navigate the evaluation and adoption of rapid and alternative microbiological methods at the hands-on PDA Alternative Microbiological Methods Workshop 2024!

  • Our experts will guide you through selecting a test method, implementing the testing platform, and preparing appropriate data packages and methods validation summaries for regulatory submission.
  • Hear in-depth presentations featuring solutions to challenges during method selection, considerations for cell and gene therapies and short shelf-life products, and best practices for validation.
  • Be inspired by case studies highlighting real-life implementation success stories.

Don’t miss out on small group work sessions providing additional takeaways related to cost, overcoming challenges, and the benefits of nontraditional microbiology test methods!

PROGRAM PLANNING COMMITTEE

  • Marc Glogovsky, ValSource, Inc. (Chair)
  • Christopher Murdock, Eli Lilly and Company
  • Olivia Venhuizen, Amgen Inc.
  • Erin Wall, U.S. FDA
  • Kevin Wright, Procter & Gamble Company

Early Registration

Register by 14 August 2024

Member Price

$1,595

GovernmentMember Only

$895

Health AuthorityMember Only

$895

Early Career ProfessionalMember Only

$1,395

StudentMember Only

$595

AcademicMember Only

$895

Non-Member

$1,995

Standard Registration

Register after 14 August 2024

Member Price

$2,095

GovernmentMember Only

$995

Health AuthorityMember Only

$995

Early Career ProfessionalMember Only

$1,495

StudentMember Only

$695

AcademicMember Only

$995

Non-Member

$2,395

See Qualifying Criteria for Member Types.

GROUP REGISTRATION DISCOUNT: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

Tuesday, 8 October EDT

Please note that there are no posters associated with this event.

Wednesday, 9 October EDT

  • Registration Open

  • P1: Evolution of Alternative Microbiological Methods and Regulatory Insights

    • Moderator: Marc Glogovsky, MS, Business Unit Manager - Microbiology, ValSource, Inc.

    Dive into the past twenty-year evolution of alternative microbiological methods and regulatory insights. Explore the change drivers, including modalities and the critical time to result for short-shelf-life release testing, shaping current industry needs. Discuss emerging next-generation scientific technologies and the key enablers facilitating the adoption of alternative methods. The second half of the plenary is focused on a comprehensive understanding of the regulatory advancements and their impact on alternative methods in the pharmaceutical, compounding, and biologics products domain. Current and former health authority regulators will share invaluable insights, including initial observations, concerns, current perspectives, and adaptations of alternative methods.
    • Welcome and Opening Remarks from Workshop Chair

      • Chair: Marc Glogovsky, MS, Business Unit Manager - Microbiology, ValSource, Inc.

    • Current Industry and Regulatory Drivers for Alternative and Rapid Microbiological Methods

      • Presenter: Michael J. Miller, PhD, President, Microbiology Consultants, LLC

    • Alternative Microbial Methods: Perspectives from Both Sides

      • Presenter: Andrew D. Hopkins, BSc Hons PGDip, Director, Operation Quality QA Audit and Compliance, AbbVie Inc.

    • Q&A

  • Networking Break in the Exhibit Area

  • P2: Real-Life Challenges to Implementing AMM

    • Moderator: Christopher A. Murdock, PhD, CQA, VP, Sterility Assurance and Microbiology Support, Eli Lilly and Company

    During this session, we'll explore the historical and present challenges associated with various Alternative Microbiological Methods (AMM) technologies. We'll highlight key considerations necessary for successful implementation of a specific AMM. Additionally, participants will engage in a case study exercise to identify regulatory risks, technology hurdles, and potential costs involved in the process.
    • Overview and Introduction: Adopting AMMs is Easy, Right?

      • Presenter: Kevin I. Wright, PhD, Director, Corporate Quality Assurance - Industrial Microbiology, Procter & Gamble

    • Simulating the Company Experience of AMMs: Small Working Groups Challenge

      • Presenter: Kevin I. Wright, PhD, Director, Corporate Quality Assurance - Industrial Microbiology, Procter & Gamble

    • Report Out and Discussion

  • Networking Reception in the Exhibit Area

Thursday, 10 October EDT

  • Continental Breakfast

  • Registration Open

  • P3: Regulatory Expectations on Alternative Microbiological Methods

    • Moderator: Erin A. Wall, PhD, Senior Pharmaceutical Quality Assessor, OPQ, CDER, U.S. FDA

    Hear U.S. FDA’s perspective on alternative microbiological techniques proposed for compounded and short shelf-life biologic products. FDA representatives will share the necessary supporting controls, investigations, and validation data required for these alternative methods. Gain additional insights into the complexities of conducting sterility testing for cell-based biologic products and patient safety during the interactive case study discussion.
    • Alternative Sterility Test Methods for Compounded Products: Points to Consider

      • Presenter: Ian F. Deveau, PhD, Division Director, OC, CDER, U.S. FDA

    • Q&A with Ian Deveau

    • Interactive Case Study: Short Shelf-life Cell and Gene Products: Assessing Alternatives and Ensuring Patient Safety

    • Report Out and Discssion

  • Networking Break in the Exhibit Area

  • P4: Releasing the Power of Alternative Microbiological Methods

    • Moderator: Kevin I. Wright, PhD, Director, Corporate Quality Assurance - Industrial Microbiology, Procter & Gamble

    Rapid alternative microbiology methods offer benefits for the timely quality release of the finished product, but one method may not be sufficient to replace the traditional method and fully comply with release specifications. Using examples and a case study, this session provides context for the use of alternative methods in sterile and hygienic manufacturing by employing a data-based approach from a finished product release focus to ensure measured process reliability and risk-managed release.
    • Introduction: Progressing to AMM Use in Quality Manufacturing Versus Quality Release

      • Presenter: Kevin I. Wright, PhD, Director, Corporate Quality Assurance - Industrial Microbiology, Procter & Gamble

    • Integration of Rapid Bioburden Testing into Production Quality Management Systems and Process Control

      • Presenter: Irina Ramos, PhD, Director of Bioprocess Technology and Engineering, AstraZeneca

    • Designing a Risk Strategy Using the Current Regulations to Replace Traditional Methods

      • Presenter: Terra Kremer, Director of Microbiological Quality, Johnson & Johnson

    • A Future of MQL and Managing Risk Release

  • Networking Lunch

  • P5: From Cultures to Code: Alternative Microbiology at the Molecular Level

    • Moderator: Olivia Venhuizen, PhD, Process Development Principal Scientist, Amgen Inc.

    In this session, gain familiarity with the current landscape of available DNA-based products and systems, what to consider when choosing a product or system, the process for implementation including risks and benefits, and the featured applications. Alternative, rapid, and growth-based technologies can be used to support the release of cell and gene therapies in seven days compared to the 14-day compendial sterility test. This accelerated timing still poses challenges to products with the life-saving requirement for immediate administration. Many challenges cannot be foreseen by vendors of molecular kits and technologies. The promising lure of molecular methods and their unique challenges will be discussed and collaboratively debated in an interactive case study.
    • Detecting DNA: Past, Present, and Future

      • Presenter: Cliff Hogan, PhD, Environmental Monitoring Manager, FUJIFILM Cellular Dynamics

      • Presenter: Amy L. McDaniel, PhD, Director, Microbial Center of Excellence & Operations, Bristol Myers Squibb

    • Implementing Molecular Methods Part 1: Mycoplasma Testing

      • Presenter: Cliff Hogan, PhD, Environmental Monitoring Manager, FUJIFILM Cellular Dynamics

      • Presenter: Amy L. McDaniel, PhD, Director, Microbial Center of Excellence & Operations, Bristol Myers Squibb

    • Report Out and Discussion: Part 1

    • Implementing Molecular Methods Part 2: Sterility Testing

      • Presenter: Cliff Hogan, PhD, Environmental Monitoring Manager, FUJIFILM Cellular Dynamics

      • Presenter: Amy L. McDaniel, PhD, Director, Microbial Center of Excellence & Operations, Bristol Myers Squibb

    • Report Out and Discussion: Part 2

  • Networking Break in the Exhibit Area

  • P6: Future Directions for Alternative Microbiological Methods

    • Moderator: Marc Glogovsky, MS, Business Unit Manager - Microbiology, ValSource, Inc.

    Microbiology laboratories often rely on traditional methods, which can limit efficient contamination control. This session delves into the current state and future potential of rapid alternative microbiology methods (AMM), examining their benefits and the challenges that may hinder their widespread adoption. By understanding these challenges, we can develop strategies to address them and unlock the full potential of rapid AMM. These advanced technologies promise to significantly reduce errors associated with manual processes, thereby enhancing contamination control and product quality. The presentation will also explore the potential role of Artificial Intelligence (AI) in facilitating the adoption and advancement of rapid AMM. AI integration could revolutionize these technologies, making them more accessible and effective. To conclude, we invite you to participate in an open discussion about the future of AMM. Share your thoughts, insights, and ideas on how we can collectively shape the evolution of microbiological methods.
    • Rapid Alternative Microbiology Methods: Stalled Progress or on the Verge of a Breakthrough?

      • Presenter: Kumbirai Dhliwayo, MS, Founder and Principal Consultant, Kumby Consulting

    • The Evolution of Alternative Microbiological Methods: Audience Insights

    • Report Out and Discussion

    • Closing Remarks from Workshop Chair

      • Moderator: Marc Glogovsky, MS, Business Unit Manager - Microbiology, ValSource, Inc.

Posters

Agenda is subject to change.

Presenters

  • Ian F. Deveau, PhD

    Division Director, OC, CDER, U.S. FDA

    Presenter
    Read Bio
  • Kumbirai Dhliwayo, MS

    Founder and Principal Consultant, Kumby Consulting

    Presenter
    Read Bio
  • Marc Glogovsky, MS

    Business Unit Manager - Microbiology, ValSource, Inc.

    Chair
    Moderator
    Read Bio
  • Cliff Hogan, PhD

    Environmental Monitoring Manager, FUJIFILM Cellular Dynamics

    Presenter
  • Andrew D. Hopkins, BSc Hons PGDip

    Director, Operation Quality QA Audit and Compliance, AbbVie Inc.

    Presenter
    Read Bio
  • Terra Kremer

    Director of Microbiological Quality, Johnson & Johnson

    Presenter
    Read Bio
  • Elizabeth Lessey-Morillon, PhD

    Senior Biologist, OTP, CBER, U.S. FDA

    Presenter
  • John Logar

    Director, Radiation Sterilization, Johnson & Johnson

    Presenter
  • Amy L. McDaniel, PhD

    Director, Microbial Center of Excellence & Operations, Bristol Myers Squibb

    Presenter
    Read Bio
  • Michael J. Miller, PhD

    President, Microbiology Consultants, LLC

    Presenter
    Read Bio
  • Christopher A. Murdock, PhD, CQA

    VP, Sterility Assurance and Microbiology Support, Eli Lilly and Company

    Committee Member
    Moderator
    Read Bio
  • Irina Ramos, PhD

    Director of Bioprocess Technology and Engineering, AstraZeneca

    Presenter
    Read Bio
  • Olivia Venhuizen, PhD

    Process Development Principal Scientist, Amgen Inc.

    Committee Member
    Moderator
    Read Bio
  • Erin A. Wall, PhD

    Senior Pharmaceutical Quality Assessor, OPQ, CDER, U.S. FDA

    Committee Member
    Moderator
    Read Bio
  • Kevin I. Wright, PhD

    Director, Corporate Quality Assurance - Industrial Microbiology, Procter & Gamble

    Committee Member
    Moderator
    Presenter
    Read Bio

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.

Individual reservations cancelled within seventy-two (72) hours prior to arrival will forfeit one night’s room deposit. Individuals will be responsible for payment of their own cancellation fees.

Located near many of DC’s most famous landmarks and museums, the Grand Hyatt Washington places you only steps from all the action. Immerse yourself in the iconic sights, unlimited shopping, and alluring nightlife of the nation's capital. At the Grand Hyatt Washington, you'll enjoy exceptional comfort and service and a direct connection to the city via the Metro Center station.

Additional Hotel Information

  • Rate: $335 + taxes/fees
  • Cut-Off Date: Friday, 06 September 2024
How to Get Here
By Air The Grand Hyatt Washington is accessible from three major airports: Ronald Reagan Washington National Airport (DCA - approx. 4 miles/6 km), the Washington Dulles International Airport (IAD - approx. 25 miles/40 km), and the Baltimore/Washington International Thurgood Marshall Airport (BWI - approx. 32 miles/51 km).
By Car The Grand Hyatt Washington is located at 1000 H Street, NW, Washington, DC 20001. Both self-parking ($12-45/day) and valet parking ($34-65/day) are available.
By Other Options The Grand Hyatt Washington is easily accessible from the Metro Center Metro stop (Blue, Orange, Red, and Silver Lines - Grand Hyatt/Hotel exit).