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FDA Pre-Approval Inspections
An Important Two-Day Comprehensive & Interactive Seminar with Case Studies and Workshops On:
- FDA, Today and Tomorrow
- FDA Rules and Regulations
- FDA’s Initiative on Pharmaceutical cGMPs for the 21st Century
- Application and Approval in the US
- FDA Inspections
- FDA Pre-Approval Inspectional Program Before, During and After
- System Based Inspections Quality, Facility & Equipment, Materials, Production, Packaging/Labeling, Lab Controls
- A Quality Systems Approach to GMPs
- Most Common GMP Deficiencies by Systems
- Expectations for cGMPs for Laboratories
- Inspections of Combination Devices
- Requirements for Inspection Preparations
- Surviving an US FDA Audit
- Criteria for Warning Letter vs Violation Letter
- Responding to FDA FD-483
Distinguished Course Leaders
Ms. Maxine Fritz
Vice President, Pharmaceutical Quality Systems and Validation
Quintiles Consulting
Mr. John Godshalk
Senior Consultant
Biologics Consulting Group
Dr. Marla Phillips
Senior Compliance Consultant
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An Important Two-Day Comprehensive & Interactive Seminar with Case Studies and Workshops On:...
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01/28/2008
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