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TESTIMONIALS

FDA Regulation Consulting

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What our clients say

Bill C.,
VP and General
Manager

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In a conversation with our one of our corporate QA/RA people, he suggested I call Jim Dunning at QualPro, now Delta Consulting Alliance, to discuss my situation which I did. I was favorably impressed with Jim’s experience, skill-set and attitude. Jim’s deep understanding of QA/RA arena went beyond the skill-set and expertise that a typical QA/RA Manager of a facility like ours could acquire, and were invaluable to our work product.

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Larry P.,
Small Medical Device Design and Manufacturer

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In a conversation with our one of our corporate QA/RA people, he suggested I call Jim Dunning at QualPro, now Delta Consulting Alliance, to discuss my situation which I did. I was favorably impressed with Jim’s experience, skill-set and attitude. Jim’s deep understanding of QA/RA arena went beyond the skill-set and expertise that a typical QA/RA Manager of a facility like ours could acquire, and were invaluable to our work product.

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Jim B.,
VP-Quality System Remediation, Cardiovascular Products

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While rebuilding the entire Quality System as part of an overall remediation strategy, Jim played a key role in the process, acting as a Quality System expert in many key areas. His experience and background were especially important in helping address product related issues. Jim’s knowledge of Risk Management was critically important in helping the company improve overall product performance and provide a foundation for future product development.

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Eric Wentorf,
Senior Project Manager, ProPharma Group

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Jim is an outstanding contributor and very knowledgeable about Quality Systems and regulatory requirements. He is also easy to work with and ensures that projects continue to move forward in a timely fashion.

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Ken Schmidt,
Consultant at
Biomet 3i

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Jim is extremely knowledgeable of all aspects of parts 820, 806 and 803 and is specially adept in implementing compliant, effective and sustainable Quality System solutions. Based on working with him on two large remediation projects, he consistently demonstrates excellent communication skills and the ability to educate and transform clients into compliant and effective organizations.

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Warren Opfer,
Principal Management Consultant and President/CEO of
LSSI

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Jim is a good friend and excellent subject matter expert in FDA regulatory compliance. He is highly sought after by clients for his expertise and sound recommendations. He has a well earned reputation for getting the job done thoroughly and with high client satisfaction. People appreciate his jovial nature and it has been a pleasure to work with him. I highly recommend Jim for his knowledge, skills, and professionalism

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