Audits - Self/Internal, Vendor and Regulatory Inspections is a webinar dedicated to internal Audit Requirements, US FDA Inspections, Vendor / Supplier Audits, Virtual Audits, Data Integrity.
Topics
- Vendor / Supplier Audits
- Key Requirements of US 21 CFR 820 device and 21 CFR 211 drug CGMPs and US FDA Inspections - QSR and QMSR Considerations
- Key Features of the Part 11 "Add-on" inspection
- Internal Audit Requirements
- Data Integrity
- Adapt the FDA "QSIT" (device) Inspection / Audit "Model"
- Conduct of Post-audit Actions; Fomal Audit Report
- The Audit Schedule, Audit Plan, Draft Audit Report
- Vendor / Supplier Audits
- Sample Audit Questionnaire and Worksheets
- Virtual Audits
- LPA (Layered Process Audits)
Who should Attend
- Company / Vendor Auditors
- R&D and Engineering
- Regulatory Affairs
- Senior management
- Production
- Quality Assurance / QAE
- Consultants
