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