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
Who Will Benefit:
Regulatory Affairs management
Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy and colonoscopy devices, where he oversees the operation of the quality system. In this position, Jeff is responsible for oversight of the document control system, including maintenance of regulatory documentation.
Compliance4All DBA NetZealous,
Full Details & Registration Link: http://www.compliance4all.com/control/w_product/~product_id=501265LIVE?channel=ticketprinting_May_2017_SEO