Notified Body Unannounced Audit Training Webinar
Medical Device Academy founder Rob Packard will review:
- What is an unannounced audit?
- What is the frequency?
- Focus of unannounced audits
- Who will perform audits?
- Processes to be sampled
- Items needed for preparation
- Definitions and much more!
Who will be audited in 2014?
“In 2014, the primary targets for unannounced audits will be manufacturers of high-risk, Class III devices. The primary targets for unannounced audits are unlikely contract manufacturers, because Notified Bodies may not have access to all the technical documentation while they are auditing a contract manufacturer. I expect each of the Notified Bodies to plan at least one unannounced audit of a contract manufacturer for a Class III device that is outsourced, but I don’t expect this to be the focus of unannounced auditing activities in 2014.”
-Notified Body Unannounced Audits Have Begun
Robert Packard-QA/RA Expert
Rob Packard provides regulatory submissions (510k, CE Marking, etc.), compliance auditing and training services for medical device manufacturers.
He has 20+ years experience in the medical device, pharmaceutical and biotechnology industries.
Rob has authored 100+ blogs on a number of topics ranging from regulatory submissions to ISO 13485 certification to management review http://robertpackard.wpengine.com/blog/