Implementing the Best Practices for FDA Inspection Preparation and Management 2014 is a webinar that covers topics such as:
- Definitions
- Statutes and Regulations
- Regulatory Requirements for Compliance
- FDA Manuals
- Inspection Types and Categories
- FDA BIMO Inspection: Scope and Depth
- Inspection Process
- Inspection Classification
- How to Answer Questions
- Hosting an FDA Inspection
- Dos and Don’ts Before, During and After FDA Inspection
- FDA Forms 482 and 483
- Misconception and Frequent Mistakes
- Responding to 483: Best Practices
- Improving Awareness and Exercising Sound Judgment
- Enforcement Cases
- Transparency, Accountability and Integrity
- Good Business and Employment Practices
- Practical, Actionable and Sustainable Recommendations: Best Practices
Implementing the Best Practices for FDA Inspection Preparation and Management 2014 is intended for:
- VPs
- CEOs
- Attorneys
- Compliance Officers
- Clinical Affairs
- Regulatory Affairs
- R&D
- Quality Assurance
- Contractors/Subcontractors
- Consultants
- Anyone Interested in the FDA (BIMO) Inspection Process
