How FDA Trains Its Investigators to Review CAPA, What You Can do to Prepare Complaint Handling in Compliance with FDA and ISO Regulations
01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes
Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar
"Jeff Kasoff, RAC, CMQ/OE, LBB, is the Principal at Lean to Quality, LLC. He has more than 30 years in Quality and Regulatory management."
The document by which FDA inspectors operate during an inspection
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.
Who Should 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.
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.
Who will Benefit
The employees who will benefit include:
• R&D Management
• Regulatory management
• QA management
• Quality system auditors
Industries who can attend
This 60-minute online course is intended for professionals in the Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies . Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.