Overview: 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 Session:
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:
Quality System Auditors
Jeff Kasoff, RAC, CQM, is the Director of Quality at Medivators, a leading manufacturer of consumables and instrumentation in the endoscopy field. Among his responsibilities is oversight of the document control system. In his 20+ years of Quality and Regulatory management, Jeff has implemented and overseen document control systems at all sizes of company, from startup to $100 million in revenue. Over that time, he has also been primary liaison with FDA inspectors and notified body auditors. Jeff received his regulatory affairs certification in 1996, and his certified quality management certification in 2013.
Live : $199.00
Corporate live : $399.00
Recorded : $249.00