- Create/Update QMS for conformance with current applicable regulations and standards
- Create full complaint handling, nonconformance, or CAPA handling systems to roll out to your company
- Train all personnel in your company or department what to do when an FDA investigator walks in the front door
- Create processes for front room and back room operations during FDA inspections
Neozene, as your Compliance Readiness partner can help you answer the following questions:
- Who can talk to the FDA investigator?
- The FDA investigator asked for my internal audit reports, do I have to show it to them?
- What do I do when an FDA investigator wants to take pictures of my manufacturing area?
- Can I record the FDA interviews in order to review them later?