How to draft an Audit Gap Analysis Agenda? An easy way to start completing your agenda is to download this sample FDA Audit Gap Analysis Agenda template now!
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This mock FDA Audit & Gap analysis Agenda contains the following:
- 9:15–10:00 a.m.: Opening meeting with firm and discussion of audit logistics, including:
- Reaffirm the audit plan
- Review the four levels of criteria used in the assessment
- Explain the record collection and sampling techniques
- Explain the reporting process and categorization of findings
- 10:00–10:30 a.m.: Facility tour
- 10:30 a.m.–Noon: Overview of compliance environment to include organizational charts, roles and responsibilities of QA, RA, records management, IT and other departments responsible for supporting and enforcing the quality system, critical supplier (CRO, CMO, contract sterilizer, etc.) lists, site master file (if any), and scheduling of afternoon interviews.
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Download this Audit Gap Analysis Agenda template now for your own benefit!