How FDA Trains Its Investigators to Review CAPA, What You Can do to Prepare Complaint Handling in Compliance with FDA and ISO Regulations

Duration: 60 Minutes
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 all the documents used by FDA to train their inspectors to review your CAPA system, 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 in your preparation.
CAPA Inspectional Objectives
Instructor: Jeff Kasoff
Product ID: 500705

Why Should you Attend:
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.

Objectives of the Presentation:
The objectives of the presentation are to deal with:
  • Documents Used by FDA Inspectors.
  • CAPA Implications of Investigations Operations Manual (IOM), and Recommended Methods of Compliance for each Requirement
  • CAPA Implications of CPG Manual 7382.845, and Recommended Methods of Compliance for each Requirement.
  • QSIT Manual: Description of each CAPA Inspectional Objective, and Recommended Methods of Compliance.
Who can Benefit:
The employees who will benefit include:
  • R&D Management
  • Regulatory management
  • QA management
  • Consultants
  • Quality system auditors
$375
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Jeff Kasoff, RAC, CMQ/OE, LBB, is the Principal at Lean to Quality, LLC. He has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup 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. Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff has the following certifications: Manager of Quality and Organizational Excellence certification from ASQ, Regulatory Affairs Certification from RAPS, and Lean Black Belt from IIE.
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