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2020ATMPs-1988x680

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

Jun 23, 2020
Eastern Standard Time | Online
  • Virtual
  • Conference
  • Online

Overview

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.

Agenda

  • 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

Highlighted Speakers

Tony Cundell
Tony Cundell
Microbiological Consulting, LLC
Anna F. Lau
Anna F. Lau
National Institutes of Health

Registration Fees

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Registration Type Price
Member $200
Non-member $200
Gov't/Health Auth./Academic $200

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