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Batch Records for Cell Therapy Products - Webinar Recording (Apr 2009)

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Description

Batch Records for Cell Therapy Products

 

Sponsored by the ISCT North American Legal and Regulatory Affairs Committee

Speakers:

  • William E. Janssen, Ph.D, Moffitt Cancer Center, Tampa, FL
  • Scott R. Burger, M.D., Advanced Cell & Gene Therapy, LLC, Chapel Hill, NC

Objectives:

  1. Understanding the concept of the batch process manufacturing versus continuous process manufacturing, and how cell therapies production fits the batch process model
  2. Understanding the concept and role of the batch process record (BPR) from the standpoint of it’s roots in manufacturing, particularly of pharmaceuticals
  3. Knowing the requirements of the FDA with respect to the BPR, and how they can serve as guidance for creating a facilities own BPR. Particularly:
    • Master process record
    • Working batch process record
    • Master process record
    • Working batch process record
    • Master process record
    • Working batch process record
  4. Establishing a minimum content for cell therapies BPR
  5. Understanding the benefits and requirements that pertain to electronic BPR

 

This product is a downloadable zipped folder containing an mp3 audio recording of the presentation and a PDF copy (or copies) of the Power Point slides.


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