How FDA Trains its Investigators to Review CAPA – 2017

How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare


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 Profile:
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.

Contact Detail:

Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com

Ad Reference ID: 99458cfb5928242c

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