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What's New with the FDA?

by Jack Dhuwalia
Jack Dhuwalia
Jack is an expert trouble-shooter specializing in the medical industry. He has b
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on Monday, 09 February 2015
Regulatory Compliance 0 Comments

solutions_buttonOCRA member Jack Dhuwalia summarizes FDA Los Angles Acting District Director Capt. Larry Howell’s summary of major Washington-based FDA overhaul coming soon.

One significant announcement was the resignation of Dr. Margaret A. Hamburg as the FDA’s commissioner.

To learn more about significant changes at the FDA coming in 2015 ... continue reading below


Jack Dhuwalia Is The Invited Presenter At ASQ Orange Empire Chapter Monthly Meeting On February 11th

by Jack Dhuwalia
Jack Dhuwalia
Jack is an expert trouble-shooter specializing in the medical industry. He has b
User is currently offline
on Thursday, 06 February 2014
Risk Management 1 Comment

Jack Dhuwalia is pleased to announce that he is an invited presenter at the local ASQ Chapter’s Monthly Meeting on February 11, 2014. The Topic is: Risk Management – ISO 14971:2012.

“EN ISO 14971:2012 - Application of Risk Management to Medical Devices”

Register Now  

The ASQ 0701 Clinic on EN ISO 14971:2012 - Application of Risk Management to Medical Devices will be held at Double Tree in Santa Ana on February 11 evening.

The program will be interactive discussing components of the standard, learning the significant changes, understanding key annexes and when/how to apply them. Risk Management is an integral part of product design, development, manufacturing and use. Medical Devices are no exception.  Regulatory bodies such as FDA expect a formal process to manage and document these activities.

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