How to Most Effectively Prepare for and Manage FDA Inspection: Best Practices 2015 is a webinar that covers topics such as:
- Definitions
- FDA Authority for Inspection
- FDA Inspection Scope, Types and Categories
- FDA Manuals for FDA Inspection
- Hosting an FDA Inspection
- FDA Inspection Process
- Responding to 483: Common Mistakes
- Answering Questions
- Misconception and Frequent Mistakes
- Dos and Don’ts Before, During and After FDA Inspection
- Best Practices: Dos and Don’ts
- Recent Enforcement Cases
How to Most Effectively Prepare for and Manage FDA Inspection: Best Practices 2015 is intended for:
- Compliance Officers
- Senior Management
- Regulatory Affairs
- Attorneys
- Quality Assurance
- Clinical Affairs
- Consultants
- R&D
- Anyone Interested in the FDA (BIMO) Inspection Process
- Contractors/Subcontractors