Audits - Self/Internal, Vendor and Regulatory Inspections

US FDA statements and actions indicate the initial and purpose of Part 11 "Add-on" inspections are being extended beyond what was to be a short term review of industry's response to Part 11. Using the field tested techniques presented in this webinar, an internal and/or supplier audit can provide much the same early warnings as a real FDA compliance CGMP audit. This webinar will provide test scripts and rationale for a "model" for company internal and supplier audits.

Areas Covered:

• Key Requirements of US 21 CFR 820 device and 21 CFR 211 drug CGMPs and US FDA Inspections - QSR and QMSR Considerations
• Vendor / Supplier Audits
• Internal Audit Requirements
• Key Features of the Part 11 "Add-on" inspection
• Adapt the FDA "QSIT" (device) Inspection / Audit "Model"
• Data Integrity
• The Audit Schedule, Audit Plan, Draft Audit Report
• Conduct of Post-audit Actions; Fomal Audit Report
• Sample Audit Questionnaire and Worksheets
• Vendor / Supplier Audits
• LPA (Layered Process Audits)
• Virtual Audits