Notified Body Unannounced Audit Training Webinar

 

Notified Body Unannounced Audit Training Webinar

Medical Device Academy founder Rob Packard will review:

unannounced audits Notified Body Unannounced Audit Training Webinar

  • 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! 

If you are interested in learning more about unannounced audits by Notified Bodies, please click on the link below to pre-register for only $79.00 (will be $129.00 after July 18th). PreRegister Button Notified Body Unannounced Audit Training Webinar

unannounced audit grphic Notified Body Unannounced Audit Training Webinar

 

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

Your Instructor

%name Notified Body Unannounced Audit Training Webinar

Robert Packard-QA/RA Expert

Rob Packard provides regulatory submissions (510k, CE Marking, etc.), compliance auditing and training services for medical device manufacturers.

Contact information:  Phone 802.281-4381, or email. You can also follow him on Google+LinkedIn or Twitter. 

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/

 

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