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Updates from Jack Dhuwalia

Blog entries categorized under Regulatory Compliance

Regulatory Compliance

3 posts in this category

Process Validation Food For Thought

by Jack Dhuwalia
Jack Dhuwalia
Jack is an expert trouble-shooter specializing in the medical industry. He has b
User is currently offline
on Friday, 10 February 2017
Regulatory Compliance 0 Comments

"The old idiom says “Sticks and stones may break my bones but words will never hurt me.” Well words can hurt you."

Process Validation is defined per CFR820.75 Process validation (a) where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance. Key phrase is “fully verified” - examples are sterility assurance. 

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
User is currently offline
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


510(k) Regulations. Is there room for improvement? Sure...But Don’t Throw the Baby Out With the Bath Water

by Jack Dhuwalia
Jack Dhuwalia
Jack is an expert trouble-shooter specializing in the medical industry. He has b
User is currently offline
on Friday, 08 February 2013
Regulatory Compliance 2 Comments

510k_productsThe recent Institute of Medicine (I of M) report brings an old idiom to life: “Don’t throw the Baby out with the Bath Water!” According to the IOM, “...The current process is untenable.”  I applaud that Dr. Jeff Shuren, Director, CDRH, FDA, has announced his support for the current 510(k) regulations to demonstrate “substantial equivalence” to a device on the market.

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