How FDA Trains its Investigators to Review CAPA - 2017

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Category Capa System, Capa Quality, FDA Inspections, quality assurance, quality assurance manager, QA Management, regulatory affairs, regulatory affairs manager, regulatory affairs associate, death by capa manz

Deadline: May 14, 2017 | Date: May 15, 2017

Venue/Country: Online, U.S.A

Updated: 2017-03-21 16:22:56 (GMT+9)

Call For Papers - CFP

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: supportcompliance4All.com