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President and Team Leader

John A. Bennan is President and founder of ComplianceNet, Inc., a consulting firm offering services in GLP/GMP compliance, quality assurance and regulatory affairs to the pharmaceutical and biopharmaceutical industries for over 16 years.  With more than 25 years industry experience, Mr. Bennan routinely performs compliance audits and mock regulatory inspections for clients.  He has written numerous regulatory submissions including CMC sections, INDs and DMFs.   His firm has set-up Quality Assurance, Quality Control, and Regulatory Affairs departments at multiple firms including all required systems and associated SOPs. Mr. Bennan has extensive experience assisting firms to develop existing personnel, expand departments with experienced personnel, and re-engineer departmental operations.

Mr. Bennan has lectured and published on the topics of GLP/GMP compliance, quality assurance, regulatory inspections, raw materials, biopharmaceuticals, process development/validation, and clinical manufacturing.  Prior to founding ComplianceNet, Mr. Bennan was the former head of Quality Assurance at Synergen (now Amgen) where he gained extensive experience in quality system design and implementation at two multi-product clinical facilities as well as the large-scale LakeCentre market manufacturing facility. He has additional experience as an analytical chemist in biotechnology, pharmaceuticals, and other regulated industries. He holds a BS in Chemistry from Northern Arizona University and an MBA from the University of Colorado.

See Mr. Bennan's full C.V.

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Team

Working with John is a team of professionals, each with at least 10 years experience in pharmaceuticals.  Additionally, all have gained broader knowledge from their years of consulting experience with other key industry leaders.  Individual specialties are varied, giving ComplianceNet many resources to pull from when examining your specific compliance questions; for example:  Process Development and Validation, Computer Validation and Part 11 Compliance, Equipment Qualification, Environmental and Utility Monitoring and other Microbiology specialties.  


FDA on Consultant's Expertise

"Sometimes a former high-ranking FDA official doesn't help you anymore than getting a consultant who ... knows the really technical stuff cold."

Mark Elengold, CBER
University of Georgia's Annual GMP conference
March 2002


Copyright 2003 Compliance Net, Inc.

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