How FDA Trains its Investigators to Review CAPA

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

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies, since a CAPA program is a requirement across the Medical Device,
Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

• QA management
• CAPA coordinator
• Regulatory Affairs management
• Executive management
• Consultants
• Quality System Auditors

Speaker Profile

Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy and colonoscopy devices, where he oversees the operation of the quality system. In this position, Jeff is responsible for oversight of the document control system, including maintenance of regulatory documentation. Prior to this, Jeff spent 13 years at Life-Tech, Inc. as the Director of Regulatory Affairs, where he was responsible for compliance of the corporate quality system. Jeff received his regulatory affairs certification in 1996.

Others Details

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