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 Introduction to GMPs (Good Manufacturing Practices) for Biopharmaceuticals

Approximate Time:  2 hours

Who Should Attend:

This course is designed to provide a basic overview of GMPs specific to manufacturing biologics. Personnel in QA, QC, Regulatory, and Manufacturing involved in ensuring GMP compliance should attend.  The course is designed as introductory and is a good fit for annual GMP or initial GMP training seminars.

Course Description: 

Biopharmaceutical firms face specific GMP requirements from the FDA and other regulatory agencies.  This course covers the history of the GMPs and why they were instituted.  It then overviews the basic requirements of the applicable regulations with an emphasis on those that specifically relate to biotechnology companies.  It is intended as an introductory course for personnel with low levels of experience in FDA regulated industry.  It provides an excellent beginning understanding of FDA expectations for firms beginning to consider producing supplies for clinical trials in humans.

Course Topics include:

bulletHistory of the GMPs
bulletWhat are the GMPs?
bulletApplication of the GMPs to Clinical Manufacturing
bulletOverview of Major Quality Systems and Documentation in GMP
bulletThe Reasons for Compliance
bulletGMP Program Implementation

 

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FDA on Training

Familiar, common problems continue to plague the industry. These include:

   -  Process Validation

   -  Raw Materials

   -  Documentation

   -  Validation

   -  Laboratory Testing

   -  Validations

   -  Deviation Reporting timeframes

   -  Change Control system

Dr. John Finkbohner, CBER, speaking at the "Well Characterized Biopharmaceuticals Meeting," San Francisco, January 2003


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