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Lori A Carr, qualified FDA regulatory professional consulting with previous FDA medical device experience.

http://www.loriacarrinc.com/

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Home - New Lori A Carr | loriacarrinc.com Reviews
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Lori A Carr, qualified FDA regulatory professional consulting with previous FDA medical device experience.
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1 FDA
2 medical device
3 ex-FDA
4 investigator
5 medical device specialist
6 previous FDA investigator
7 compliance
8 regulatory
9 mock FDA inspections
10 mock FDA audits
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Home - New Lori A Carr | loriacarrinc.com Reviews

https://loriacarrinc.com

Lori A Carr, qualified FDA regulatory professional consulting with previous FDA medical device experience.

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1

Special Services - New Lori A Carr

http://www.loriacarrinc.com/services/special-services

We are available to assist clients with special projects that require expert experience in areas as follows:. FDA Compliance Follow-up for FDA inspections, FDA-483s, and Warning Letters. FDA Inspection Readiness Training. Premarket PMA and 510(k) inspections. Postmarket PMA and 510(k) inspections. QSIT (Quality System Inspectional Technique). FDA Inspection Readiness for routine cGMPs/Quality System Regulation. Auditing Certification and services. CAPA and nonconformance material handling.

2

Media - New Lori A Carr

http://www.loriacarrinc.com/media

Videos of speeches, presentations, and everything else :). Lori A. Carr, Inc. Incorporated in the State of Colorado in January 2007. Registered and Licensed Business in the City of Aurora, Colorado (License Number 177426). Has General Liability Insurance and. Has business Worker Compensation Insurance. Request Lori's resume here. To get in contact with Lori. By Jaana, Inc. DBA Jaana At Work.

3

Testimonials - New Lori A Carr

http://www.loriacarrinc.com/about-lori/testimonials

John Beasley, MSc, RAC (US). Senior Consultant at MedTech Review, LLC. Lori worked as a member of the Steering Committee while I was the Quality System Manager Lead Consultant for our Asian client. Our work successfully developed the capabilities of our client's staff in dealing with the day to day operations and decisions necessary to be compliant with the US FDA's Quality System Regulations (21 CFR 820). President, Accurate Consultants, Inc. Lori is a vetern ex-FDA Investigator, who is now an expert re...

4

Certifications - New Lori A Carr

http://www.loriacarrinc.com/about-lori/certifications

In 2010, Lori obtained the U.S. Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) and the Certified Quality Auditor (CQA) certification from the American Society for Quality (ASQ). US Regulatory Affairs Certification (RAC). Regulatory Affairs Certification, known as the RAC, is the only certification specifically for regulatory professionals in the healthcare product sector. The RAC credential is a professional distinction that denotes commitment to excel...

5

Experience - New Lori A Carr

http://www.loriacarrinc.com/about-lori/experience

Some of Lori's experience includes:. Senior FDA Medical Device Specialist Investigator. FDA Level II Medical Device Certification. FDA Medical Device Performance Auditor. Trained new FDA Investigators in conducting medical device inspections. Previous Adjunct Professor of Regulatory Affairs at Colorado State University (Fort Collins, CO) for 21 CFR 820 and ISO 13485:2003. FDA Foreign Inspection Team Member and conducted PMA preapproval and postmarket inspections. Remediated FDA Warning Letters.

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