Qualifications of Auk's key team members:

Dennis M Moore is currently Chief Technical Expert and CEO of Auk Technical Services LTD, Beverly Hills, CA. Mr. Moore has 27 years of experience in medical device design, quality systems training, pharmaceutical manufacturing and 21 CFR 210,211 quality systems. Mr. Moore also has extensive experience helping firms achieve compliance to FDA regulation and International Standards regulations. Mr. Moore has extensive experience as an FDA Investigator, California Medical Device Senior Investigator, Sworn Government-POST Certified Criminal Investigator, Lead Trainer, Compliance Officer and company Chief Technical Expert and CEO.

Mr. Moore has given numerous web seminars on GMP issues; has traveled the world putting out FDA compliance related fires and authored many documents on quality system inspection, FDA/CA narrative report compilation, drug quality systems and software auditing techniques.

Mr. Moore is a member of RAPS, AAMI and is a former official with the State of California Medical Device Team. Mr. Moore also has RAB certification to the ISO 13485:2003 standard. Mr. Moore holds a BA degree in Zoology, with Graduate work in Toxicology and a POST certified Government Criminal Investigator peace officer badge <retired>

 

Detailed Qualifications:

Dennis Moore:  resume

Dr. Alfredo Quattrone:  resume   510k review - 8 year summary

Dr. Michelle Herrera Foster:  resume  

David G.Estes Foster:  resume