FDA Warning Letter Close-Out Program 2014 is a webinar that covers topics such as:
- FDA Enforcement and Compliance Manuals
- Applicable Laws and Regulations
- Hosting an FDA Inspection
- FDA Inspection Guides
- FDA Forms 482 and 483
- Factors/Matters Leading to Warning Letters
- The Common Deficiencies during FDA Inspections for Firms (Food, Devices, and Pharmaceuticals)
- Establishment Inspection Reports (EIRs)
- What to Discuss During Close Out Meeting at the End of an Inspection
- How to Communicate Before, During and After FDA Inspection: Dos and Don’ts
- Dealing with Warning Letters
- Responding to 483s, if issued
- FDA’s Warning Letter "Close-Out" Program
- Consequences of Inadequate Corrections and Repetitive Violations
- When FDA Issues a Close-Out Letter
- Warning Letter Close-Out Timelines based on 32 Cases
- Good Practices
- When FDA Doesn’t Issue a Close-Out Letter
FDA Warning Letter Close-Out Program 2014 brings together:
- VPs
- CEOs
- Attorneys
- Compliance Officers
- Clinical Affairs
- Regulatory Affairs
- R&D
- Quality Assurance
- Contractors/Subcontractors
- Consultants
- Anyone Interested in the FDA inspection Process
