PDA Alternative Microbiological Methods Workshop 2024
Sunsetting Traditions: The Dawn of Applying and Embracing Change
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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.
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
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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.
Grand Hyatt Washington
1000 H Street, NWWashington, DC 20001 United States
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.
Additional Hotel Information
- Rate: $335 + taxes/fees
- Cut-Off Date: Friday, 06 September 2024
How to Get Here
Registration
Pricing Options
Standard Registration
Member Price
$2,095GovernmentMember Only
$995
Health AuthorityMember Only
$995
Early Career ProfessionalMember Only
$1,495
StudentMember Only
$695
AcademicMember Only
$995
Non-Member
$2,495
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].
Presenters
Meet the Experts
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Andrew D Hopkins, PGDip
AbbVie
Director, Operation Quality QA Audit and Compliance
Presenter
Read Bio -
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Amy L. McDaniel, PhD
Bristol Myers Squibb
Director, Microbial Center of Excellence & Operations
Presenter
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Christopher A. Murdock, PhD, CQA
Eli Lilly and Company
VP, Sterility Assurance and Microbiology Support
Committee Member
Moderator
Read Bio -
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Olivia Venhuizen, PhD
Amgen Inc.
Process Development Principal Scientist
Committee Member
Moderator
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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
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