Regulatory Open Forum

I absolutely have a great recommendation, however, they are based in Colorado. They do travel and have colleagues around the US that they utilize.

Let me know if you would like their information.

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Jennifer Travis
Front Range Labs
Loveland CO
United States

Original Message:
Sent: 20-Jul-2016 11:16
From: Stacy Ralston
Subject: Affordable Quality Auditors in California Area

Hi All,

I am fairly new to the field and just got the RAC. I have been working over the past couple of years with a start-up biotech company in Davis managing regulatory submissions as well as pre-clinical studies and quality management systems. As one might imagine - this is a bit overwhelming. 

I am wondering if anyone can recommend a 3rd party auditor in the California area? I have been doing internal quality audits according to GLP and QSIT guidelines, but really need some one outside of the company to do a complete audit prior to our 510(k) submission in late October. Does anyone have any recommendations?

Thank you! 

--

Best Regards,

Stacy Ralston MPH, MLS(ASCP), RAC

Hi Stacy,

If you are not able to find someone in California, I am based in the Chicago area. I am a toxicology and GLP consultant, so I also understand the science behind the studies. I have both my DABT and RQAP-GLP, and have been consulting for 16 years. GLP audits and GLP training are services that I provide on a regular basis. Please let me know if you want more information. My e-mail is robinguy@robinguy.com.

Best regards,

Robin

------------------------------
Robin Guy, MS DABT. RQAP-GLP
Toxicology and GLP Consultant
Robin Guy Consulting, LLC
Lake Forest IL
robinguy@robinguy.com
United States

Original Message:
Sent: 20-Jul-2016 11:16
From: Stacy Ralston
Subject: Affordable Quality Auditors in California Area

Hi All,

I am fairly new to the field and just got the RAC. I have been working over the past couple of years with a start-up biotech company in Davis managing regulatory submissions as well as pre-clinical studies and quality management systems. As one might imagine - this is a bit overwhelming. 

I am wondering if anyone can recommend a 3rd party auditor in the California area? I have been doing internal quality audits according to GLP and QSIT guidelines, but really need some one outside of the company to do a complete audit prior to our 510(k) submission in late October. Does anyone have any recommendations?

Thank you! 

--

Best Regards,

Stacy Ralston MPH, MLS(ASCP), RAC

Hi Stacy,

Congratulations on your RAC.  I also work for a small start up so finding RA/QA consultants as an affordable price is a challenge we face as well.  We have worked with Experien Group for several years now.  They are based in Sunnyvale but have auditors/consultants that work remotely as well.  In fact, the person we work most with is based out of Modesto.  You can find their info Welcome to the EXPERIEN GROUP.

Hope this helps and good luck.

------------------------------
Monica Barrett RAC
Dir. RA/QA

Original Message:
Sent: 20-Jul-2016 11:16
From: Stacy Ralston
Subject: Affordable Quality Auditors in California Area

Hi All,

I am fairly new to the field and just got the RAC. I have been working over the past couple of years with a start-up biotech company in Davis managing regulatory submissions as well as pre-clinical studies and quality management systems. As one might imagine - this is a bit overwhelming. 

I am wondering if anyone can recommend a 3rd party auditor in the California area? I have been doing internal quality audits according to GLP and QSIT guidelines, but really need some one outside of the company to do a complete audit prior to our 510(k) submission in late October. Does anyone have any recommendations?

Thank you! 

--

Best Regards,

Stacy Ralston MPH, MLS(ASCP), RAC

Hi Stacy,

First, congratulations on your RAC! That is the result of effort and experience and I am happy for you.

Second - it may be best to get suggestions for multiple auditors and then interview them to see who has the combination of experience and style that suit you best. Two folks come to my mind, Kiran Gulati and Bruce Haggar. Both have done internal audits for my company (we rotate the 3rd party auditors used.)

Another thought - are you intending to pursue CE mark for your device? If so, depending on your device classification, you may need a notified body to certify you to ISO 13485. If this is in your future, you may want to work with an auditor who can asses you on your implementation of ISO 13485 (for complying with cGMPs.)

Best of luck!

------------------------------
Joanne Pelaschier RAC,CQA/E
Quality Engineer III
Stellartech Research
Milpitas CA
United States

Original Message:
Sent: 20-Jul-2016 11:16
From: Stacy Ralston
Subject: Affordable Quality Auditors in California Area

Hi All,

I am fairly new to the field and just got the RAC. I have been working over the past couple of years with a start-up biotech company in Davis managing regulatory submissions as well as pre-clinical studies and quality management systems. As one might imagine - this is a bit overwhelming. 

I am wondering if anyone can recommend a 3rd party auditor in the California area? I have been doing internal quality audits according to GLP and QSIT guidelines, but really need some one outside of the company to do a complete audit prior to our 510(k) submission in late October. Does anyone have any recommendations?

Thank you! 

--

Best Regards,

Stacy Ralston MPH, MLS(ASCP), RAC

Hello Stacy

I head up Qserve's west coast US office. 

Qserve is the largest EU based medical device consulting firm. 

A list of our services is included here - http://www.qservegroup.com/services

Our expertise areas are listed here - Expertise (at the bottom of this page, you can also see some free whitepapers on various subjects, from ISO 13485:2016 to MEDDEV 2.7.1 rev 4).

More information on my background is included here - Keith Morel | LinkedIn

In summary, I am an ISO 13485:2003 certified lead auditor, an ASQ CBA, I worked for KEMA/DEKRA for 9 years as a MDD lead auditor and design dossier reviewer; I am also CMDCAS certified auditor. I've held several roles in industry, most recently as Sr Director of Regulatory Compliance at Accuray, where I steered the organization through a successful FDA inspection (no 483s) after driving the Inspection Readiness program. 

I'm based in the Bay Area (I lived in Sacramento for 6 years prior to that, so I know Davis reasonably well).

I believe we could help you with your request. 

Why not take a look at our website and if any of that seems interesting, drop me a line and we can talk more about the details. 

Warm regards

Keith

916 606 4820 

keith.morel@qservegroup.com

------------------------------
Keith Morel PhD
Belmont CA
United States

Original Message:
Sent: 20-Jul-2016 11:16
From: Stacy Ralston
Subject: Affordable Quality Auditors in California Area

Hi All,

I am fairly new to the field and just got the RAC. I have been working over the past couple of years with a start-up biotech company in Davis managing regulatory submissions as well as pre-clinical studies and quality management systems. As one might imagine - this is a bit overwhelming. 

I am wondering if anyone can recommend a 3rd party auditor in the California area? I have been doing internal quality audits according to GLP and QSIT guidelines, but really need some one outside of the company to do a complete audit prior to our 510(k) submission in late October. Does anyone have any recommendations?

Thank you! 

--

Best Regards,

Stacy Ralston MPH, MLS(ASCP), RAC