How FDA Trains its Investigators to Review CAPA - 2017
Year after year, CAPA is the subsystem cited most frequently during FDA inspections. 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 techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, 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 to increase the likelihood of a positive outcome during the inspection.
Areas Covered in the Session:
- Documents Used by FDA Inspectors
- Investigations Operations Manual (IOM)
- CPG Manual 7382.845
- QSIT Manual
Who Will Benefit:
- QA management
- CAPA coordinator
- Regulatory Affairs management
- Executive management
Speaker and Presenter Information
Jeff Kasoff, RAC
Director of Quality, Byrne Medical
Byrne Medical is a leading manufacturer of endoscopy and colonoscopy devices. Jeff oversees the operation of the quality system. In this position, he is responsible for oversight of the document control system, including maintenance of regulatory documentation.
Relevant Government Agencies
FDA
Event Type
Webcast
This event has no exhibitor/sponsor opportunities
When
Mon, May 15, 2017, 10:00am - 11:00am
PT
Cost
General Admission: | $150.00 |
Website
Click here to visit event website
Organizer
NetZealous - Compliance4All