Ensuring compliance is not a hindrance to productivity requires understanding product development, commercialization, and regulatory compliance:
Five years later and, in my opinion, the strategies and controls you helped us build and put into place should be the model for anyone needing to enhance productivity while dealing with regulatory compliance.
– Timothy Beane, Vice President, Richmond, Virginia
Passing FDA, ISO, and other inspections is more than just doing the minimum required by regulations and statutes; it’s about showing the inspector that you “get it.” You understand the balance between patient and profit, and you have the records and the processes to prove it.
If you need help preparing for an FDA inspection or ISO audit, consider our mock FDA audit service. And make sure to check out these resources:
- Preparing for an FDA Inspection from the PDA Letter
- Checklist: Managing the Inspection
- Recorded Seminar & Resource Kit: Bulletproof Yourself against FDA Enforcement