Overview:
Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with.
Also contained in this session will be a section-by-section summary of the CAPA subsection of the QSIT, the document by which FDA inspectors operate during an inspection, as well as how your company can use that same document to increase the likelihood of a positive outcome during the inspection.
Areas Covered in the Session:
- Documents Used by FDA Inspectors
- Investigations Operations Manual (IOM)
- CAPA Implications
- Recommended Methods of Compliance for each Requirement
- CPG Manual 7382.845
- CAPA Implications
- Recommended Methods of Compliance for each Requirement
- QSIT Manual
- Description of each CAPA Inspectional Objective
- Recommended Methods of Compliance
Speaker
Jeff Kasoff ,RAC,CMQ/OE is the Principal Consultant at Lean to Quality, LLC. He has more than 30 years of experience in Quality and Regulatory management. Over that time, He has implemented and overseen quality system operations and assured compliance, at all sizes of company, from start-up to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes.
Who Should Attend
- QA Management
- CAPA Coordinator
- Regulatory Affairs Management
- Executive Management
- Consultants
- Quality System Auditors
