How FDA Trains Its Investigators to Review CAPA, and What You Can do to Prepare

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.

Why Should You Attend:

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.

Areas Covered in the Webinar:

• 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 will Benefit:

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
• Consultants
• Quality System Auditors

Instructor Profile:

Jeff Kasoff, RAC, is the Director of Quality at Medivators, a leading manufacturer of endoscopy consumables and instrumentation. In this position, Jeff is responsible for oversight of the quality system, including the CAPA program, and is the liaison with FDA. For the previous 13 years, Jeff served as Director of Regulatory Affairs at Life-Tech, Inc., in which capacity he was similary responsible for quality system oversight. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.