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View Full Version : PMAP (single outside audits for both FDA, HC)--anyone doing?


MIREGMGR
6th September 2008, 04:36 PM
This FDA document (http://www.fda.gov/cdrh/ap-inspection/pmap-qa.html) describes the ongoing Pilot Multi-Purpose Audit Program (PMAP), in which an approved device maker meeting certain qualifications can contract with a third-party auditing organization (AO) to provide auditing services, and those single audits will be accepted by both FDA and HC in place of separate audit processes by those agencies' own inspectors.

Is anyone here affiliated with a participating device maker, or an AO? What's been your experience so far?

Coury Ferguson
8th September 2008, 06:59 AM
Anyone have some input?