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Process Validation Food For Thought

by Jack Dhuwalia
Jack Dhuwalia
Jack is an expert trouble-shooter specializing in the medical industry. He has b
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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


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
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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.

EN ISO 14971 – Risk Management: ALERT

by Jack Dhuwalia
Jack Dhuwalia
Jack is an expert trouble-shooter specializing in the medical industry. He has b
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on Tuesday, 07 May 2013
Risk Management 1 Comment

risk_womanThe revised EN ISO standard is effective now – it is past the “grace period!” Risk Management has now become a serious business!  Please do not take it lightly; The time is now!  

The EN ISO 14971:2012 Medical Devices Application of Risk Management to Medical Devices was published in July, 2012 and became effective on 10/30/2012 … simultaneously as the preceding 2007-2009 standard was discontinued.  This was a rather brief notice to allow those in the industry to get prepared.  Wonder if this is a preview of things to come … who knows?

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.

Packaging and the Product Development Process

by Jack Dhuwalia
Jack Dhuwalia
Jack is an expert trouble-shooter specializing in the medical industry. He has b
User is currently offline
on Wednesday, 09 January 2013
JD Consulting in the News 0 Comments

Posted by Healthcare Packaging on February 09, 2011

A WIIFM (what’s in it for me) approach can help packaging professionals communicate with management that packaging is part of the solution in the medical device product development process.

Effective Design Control

by Jack Dhuwalia
Jack Dhuwalia
Jack is an expert trouble-shooter specializing in the medical industry. He has b
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on Thursday, 15 November 2012
Product Development 0 Comments

design_control_transition JD Consulting helped to develop a design control system that not only helped the client with their product development process, but also passed FDA inspection.

Process Optimization

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, 10 September 2012
Process, Package, & Sterilization Validation 0 Comments

process_optimizationRead how JD Consulting helped to solve a thorny packaging and sterilization problem and not only helped to prevent waste, but also empowered the manufacturing department to effectively implement a quality process.

 

FDA Town Hall Meeting in San Francisco, September 2011

by Jack Dhuwalia
Jack Dhuwalia
Jack is an expert trouble-shooter specializing in the medical industry. He has b
User is currently offline
on Tuesday, 16 August 2011
510(k) Regulation 2 Comments

Jack is working on preparing for the next town hall meeting in San Francisco in September with Dr. Shuren and other FDA people. Any comments or input for this meeting would be appreciated. Just add to this post, or send an email to This e-mail address is being protected from spambots. You need JavaScript enabled to view it.

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