How FDA trains its investigators to review CAPA and what should you do to prepare

Why Should You Attend:

CAPA is the most cross-functional of all subsystems of your QMS. Firms have different CAPA processes which utilize different definitions and terminology for the same meanings. Having advance knowledge and awareness of what to expect during the FDA inspection will drastically assist your firm in the ability to anticipate the inspector’s questions, and how to “translate” your CAPA system into what the inspector is looking for.

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 straightforward proven recommendations how your company can use that same document in your preparation.

Learning Objective:

• Understanding of CAPA implications in all FDA Inspection documents
• Expectation of FDA inspector’s practices
• Recommended practices to assure compliance with each topic reviewed by FDA inspector
• How to prepare your team for FDA inspection

Areas Covered in the Webinar:

• Documents Used by FDA Inspectors
• Operations Manual (IOM)
• CAPA Implications, by Section
• Requirements
• Recommended Methods of Compliance for Each Requirement
• CPG Manual 7382.845
• CAPA Implications, by Section
• Requirements
• Recommended Methods of Compliance for Each Requirement
• QSIT Manual
• Description of each CAPA Inspectional Objectives
• Description/explanation
• Recommended Methods of Compliance

Who Will Benefit:

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

• CAPA Coordinators
• Executive Management
• R&D management
• Regulatory management
• QA management
• Consultants
• Quality system auditors

Jeff Kasoff
Director of Quality, Medivators

Jeff Kasoff, RAC, CMQ/OE has more than 30 years of experience 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 start-up 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, his Manager of Quality and Organizational Excellence certification from ASQ, and his Lean Black Belt from IIE.

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