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In this section: CDER Small Business & Industry Assistance (SBIA)

FDA Small Business Regulatory Education for Industry (REdI) Conference “Focus on CGMPs and FDA Inspections” Summer 2015 Presentation Slides

Day 1 - July 15

A Review Perspective on the Pharmaceutical Quality System
Production and Process Controls: Overview of CGMP Regulations and Regulatory Expectations
Laboratory Controls & Microbiology Testing â CGMP Regulations & Guidance
Facilities & Equipment

Day 2 - July 16

Materials System: Basic CGMP Requirements
Packaging & Labeling
What to Expect During a FDA Drug Manufacturing Inspection
Case Studies

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