How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare

Date: Friday August 25, 2017

Time: 1:00 PM ET | 10:00 AM PT

Duration: 90mins with Q&A

Webinar Description:

This CAPA investigation training will discuss techniques used by the FDA to review your CAPA system. You will learn what the FDA tells their inspectors to focus in the QSIT document and how your company can use the same QSIT document to prepare for inspection. 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.

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Jeff Kasoff, RAC, CMQ/OE

Jeff Kasoff, RAC, CMQ/OE 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 received his Regulatory Affairs Certification from RAPS in 1996, his Manager of Quality and Organizational Excellence certification from ASQ in 2013, and his Lean Black Belt from IIE in 2014.

Date: Friday August 25, 2017
Time: 1:00 PM ET | 10:00 AM PT
Duration: 90mins with Q&A

Topics covered in this webinar:

  • Documents Used by FDA Inspectors: IOM, CPG, QSIT
  • 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 Should 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. The employees who will benefit include:
  • R&D Management
  • Regulatory management
  • QA Management
  • Executive Management
  • Quality System Auditors
Single Registration
Single Attendee: $195.00 + HST CAD per session
Single attendee refers to single participant at a single computer/login.

Group Registration
Group of 5 or less per location: $400.00 + HST CAD per session
Group of 6 to 10 attendees per location: $750.00 + HST CAD per session
Group of 11 to 20 attendees per location: per location: $1250.00 + HST CAD per session
Group rates only apply to candidates who wish to have more than one attendee, but will be attending the webinar from a single computer/login. If multiple candidates wish to login at different locations, it will be considered as a separate additional registration and will require more than one webinar login information. Also note that one login information will only be valid on one computer.

Please contact us at for multiple-location group rates or any other enquiries.

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