PDA Alternative Microbiological Methods Workshop 2024

Sunsetting Traditions: The Dawn of Applying and Embracing Change

09 Oct - 10 Oct 2024
Washington, DC

Become a Sponsor and/or Exhibitor

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.

The PDA Alternative Microbiological Methods Workshop 2024 navigates the evaluation and adoption of rapid and alternative microbiological methods with a focus on emerging and alternative technologies and innovations that will push the industry forward.

Why Attend?

This workshop is structured to ensure you are immersed in substance, enlightened by analysis of real-world case studies, and given the opportunity to work and engage with your fellow attendees alongside the experts.

  • 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, regulatory expectations, 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.
  • Participate in small group work sessions providing additional takeaways related to cost, overcoming challenges, and the benefits of nontraditional microbiology test methods.
What You Gain
  • Comprehensive knowledge of topics ranging from the evolution of alternative microbiological methods to successful implementation strategies.
  • Insights into regulatory expectations, provided directly by representatives from U.S. FDA CDER and CBER.
  • Immediate application of new knowledge and understanding through group discussions, case studies, role-playing exercises, and interactive polls.
  • Multiple opportunities build a professional network and connect with peers and experts across the workshop.

This workshop sells out quickly! Save your seat today.

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

Program Planning Committee

The Team Behind the Event's Agenda

Promotions and Press

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Location and Travel

Venue Details and Accommodations

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).

Registration

Pricing Options

Standard Registration

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

$2,495

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 registration@pda.org.

Presenters

Meet the Experts
  • Ian F. Deveau, PhD

    U.S. FDA

    Division Director, OC, CDER

    Presenter
    Read Bio
  • Kumbirai Dhliwayo, MS

    Kumby Consulting

    Founder and Principal Consultant

    Presenter
    Read Bio
  • Marc Glogovsky, MS

    ValSource, Inc.

    Business Unit Manager - Microbiology

    Chair
    Moderator
    Read Bio
  • Cliff Hogan, PhD

    FUJIFILM Cellular Dynamics

    Environmental Monitoring Manager

    Presenter
    Read Bio
  • Andrew D Hopkins, PGDip

    AbbVie

    Director, Operation Quality QA Audit and Compliance

    Presenter
    Read Bio
  • Terra Kremer, PhD

    Johnson & Johnson

    Director of Microbiological Quality

    Presenter
    Read Bio
  • Elizabeth Lessey-Morillon, PhD

    U.S. FDA

    Senior Biologist, OTP, CBER

    Presenter
    Read Bio
  • John Logar

    Johnson & Johnson

    Director, Radiation Sterilization

    Presenter
    Read Bio
  • Amy L. McDaniel, PhD

    Bristol Myers Squibb

    Director, Microbial Center of Excellence & Operations

    Presenter
    Read Bio
  • Michael J. Miller, PhD

    Microbiology Consultants, LLC

    President

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

    Eli Lilly and Company

    VP, Sterility Assurance and Microbiology Support

    Committee Member
    Moderator
    Read Bio
  • Irina Ramos, PhD

    AstraZeneca

    Director of Bioprocess Technology and Engineering

    Presenter
    Read Bio
  • Olivia Venhuizen, PhD

    Amgen Inc.

    Process Development Principal Scientist

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

    U.S. FDA

    Senior Pharmaceutical Quality Assessor, OPQ, CDER

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

    Procter & Gamble

    Director, Corporate Quality Assurance - Industrial Microbiology

    Committee Member
    Moderator
    Presenter
    Read Bio

Sponsors

Sponsors and Collaborators

Exhibitors

Exhibitors and Innovators
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Contact Us
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Contact

Program Inquiries
Brooke Lustig, CMP
Tel: +1 (301) 656-5900

Exhibition/Sponsorship Inquiries
David Hall
Tel: +1 (240) 688-4405

Training Course Inquiries
David Hall
Tel: +1 (301) 656-5900

Registration Customer Care
Tel: +1 (301) 656-5900