# Description of each CAPA Inspectional Objective

**Dates:** 2026-05-05 – 2026-05-05
**Duration:** 1 day
**Location:** Online , Fremont, United States
**Website:** https://www.s2mtraining.com/webinar/how-fda-trains-its-investigators-to-review-capa-and-what-you-should-do-to-prepare-30681live
**Organizer:** [s2m training](https://tradefest.io/en/search?organizer=s2m-training)
**Size:** 100 attendees

## Description

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
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.

https://www.s2mtraining.com/webinar/how-fda-trains-its-investigators-to-review-capa-and-what-you-should-do-to-prepare-30681live

## About

The 2020 edition of Description of each CAPA Inspectional Objective will take place on September 9, 2020 at Online  in Fremont (United States).

## Topics

- Pharmaceuticals

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