FDA Inspection Readiness for Dietary Supplements
Preparing for an FDA inspection for dietary supplements will help you avoid getting a warning letter and the regulatory and business consequences that come with it. Establishing a relationship of professional trust between you and the FDA requires preparation well before the inspection, thoughtful management during the inspection and thorough follow-up after the inspection.
This course walks you through the entire process. Participants will learn who should be on the company’s inspection teams, what roles they need to prepare for and how employees should act when questioned by inspectors.
Learning Outcomes
At the end of the course, you will know and understand:
- The regulatory context for FDA inspections of dietary supplements
- What to expect during these inspections
- Business consequences if the inspection does not go well
- Critical steps to accomplish before any inspection ever takes place
- How to effectively manage the inspection process and any issues that arise during the inspection to optimize the outcome
- How to establish a relationship of professional trust with the FDA and the advantages
- Essential elements of follow-up activities to ensure a positive ending to the inspection and to position your company for the next one
Who Should Attend
This dietary supplements FDA regulatory training is suitable for:
- Management
- Manufacturing
- Quality control/assurance
- Packaging
- Laboratory operations
- Auditing
- Legal
- Regulatory affairs
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