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.

1. How FDA Trains Its Investigators to Review
CAPA, What You Can do to Prepare Complaint
Handling in Compliance with FDA and ISO
Regulations
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2. Instructor 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.
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3. Description:
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.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

4. 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.
Who can Benefit?
The employees who will benefit include:
 R&D Management
 Regulatory management
 QA management
 Consultants
 Quality system auditors
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5. 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.
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6. Live Session - How it works?
 Username and Password will be sent to you 24 hours prior to the webinar
 Presentation handouts in pdf format will be mailed to you
 Login to the session using the username and password provided to you
 Get answer to your queries through interactive Q&A sessions via chat
 Get certification of attendance.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

7. Recorded Session - How it works?
 A link will be provided to you upon purchase of the recorded session
 Please click on the link to access the session
 Presentation handouts in pdf format will be mailed to you
 Get certification of attendance.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

8. Get Connected With Us:
www.onlinecompliancepanel.com
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com