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Key GMP Systems in Pharmaceutical and Biotech Labs: 2-Day In-person Seminar
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Organizer :
Topic : Biologia e ciências da vida;
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Description :
This workshop will provide the audience with an overview of the key systems which have been mentioned by FDA inspectors as major areas of concern in FDA regulated pharma laboratories. The topics addressed will include FDA requirements for OOS investigations, equipment program, pharmaceutical and biologics stability programs, method validation and handling regulatory inspections. During the discussion of each of the areas listed below, the workshop participants will work through a series of related FDA 483s to fully understand FDA expectations and the errors which lead to the 483s.
Who Will Benefit:
- QC chemists, supervisors and managers
- R&D chemists, supervisors and managers
- QA managers and personnel
- Regulatory affairs personnel
Key GMP Systems in Pharmaceutical and Biotech Labs: 2-Day In-person Seminar to be held from 12 fevereiro 2015 to 13 fevereiro 2015 in Philadelphia, PA, Estados Unidos. It covers various areas of Biologia e ciências da vida including . For more information, visit the website of the conference or contact the organizer.
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