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How to Meet GMPs for Phase 1 Trials- Recording

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ISCT Webinar: How to Meet GMPs for Phase 1 Trials

Presented by the ISCT North American Legal and Regulatory Affairs Committee 

Date: January 23rd, 2013 

Time: 9:00 AM Pacific, 11:00 AM Central, 12:00 PM Eastern, 6:00 PM CET (Europe) 

Chair and Speaker: Deborah Griffin, MSc, Quality Assurance Manager for Cellular Therapies, University of Pittsburgh Cancer Institute, USA 

Speaker:  Angela Pardee, Postdoctoral Associate, Dept. Medicine, University of Pittsburgh, presenting on behalf of Lisa H. Butterfield, Ph.D. Associate Professor of Medicine, Surgery and Immunology Director, UPCI Immunologic Monitoring and Cellular Products Laboratory University of Pittsburgh  

About the Webinar:  

Goals of the webinar (for the presenters):

1. Review the FDA Guidance for the statutory GMPs for Phase 1 clinical trials

2. Discuss changes required whether going from full GMP or from non-GMP processing  

Learning objectives (for the participants):

1. Know where to find statutory GMP and the Guidance

2. Understand the implications to a facility and its processing/manufacturing

3. Document the review of the requirements and any changes made to a facility’s process

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