PDA Webinar: The Need for Speed: A Risk-Based Approach to Optimize Time and Patient Safety

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Moderator: Lori L. Daane, PhD, Director of Scientific Affairs, bioMérieux 

Cell therapy production is a complex process that occurs over several days and involves multiple aseptic processing steps. Time is critical for both product efficacy and patient survival. The final product cannot be terminally sterilized and there is no time for traditional sterility testing, therefore a risk-based approach to microbial contamination and control is being adopted.

In this webinar, industry experts will first describe a risk-based approach and ways to identify and mitigate risk of contamination for cellular therapy production. You will be presented with a detailed case study that includes the resources needed for success and the most common risk factors that require extra attention.

This webinar closes out with an extensive comparative study that identifies an ideal and cost-effective testing combination to maximize sensitivity, reduce risk, and minimize labor.

Following the presentations, get your questions answered during a live 30-minute Q&A session with the speakers.

This webinar is presented as part of the 2020 PDA Advanced Therapy Medicinal Products Month.

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Standard Member Price

$200

GovernmentMember Only

$200

Health AuthorityMember Only

$200

AcademicMember Only

$200

Non-Member

$200

See Qualifying Criteria for Member Types.

Day 1

11:00 a.m. – 11:30 a.m.
Risk Assessment Approach to Microbiological Controls of Cellular Therapies
Tony Cundell, PhD, Principal Consultant, Microbiological Consulting, LLC

11:30 a.m. – 12:00 p.m.
Comparative Performance Evaluation of USP<71>, BacT/ALERT Dual-T, and Bactec FX for Contaminant Detection in Cell Products, Viral Vectors, and Radiolabeled PET-Drugs
Anna F. Lau, PhD, D(ABMM), Chief, Sterility Testing Service, National Institutes of Health

12:00 p.m. – 12:30 p.m.
Q&A with Speakers
Agenda is subject to change.

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