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ohn K. Willenbrock,
President of Gas Regs, Inc., has over twenty-five years of experience in management and consulting
positions demanding knowledge and skill in FDA regulatory affairs and quality assurance. He has
conducted and managed compliance audits, quality system assessments, training programs and SOP
development programs. With a strong problem solving background, John can coordinate and develop
action plans and programs from concept through implementation in the most cost efficient manner.
Prior to establishing Gas Regs, Inc., in 1994, Mr. Willenbrock was head of the Airco / BOC
Gases Quality Assurance department, managing that company's nationwide medical gases QA program
for over 200 facilities. He established a CGMP compliance program for BOC's home health care
division, and served as BOC's primary FDA and industry association contact for all medical gas
matters. Mr. Willenbrock wrote the Chemistry, Manufacturing Control section for an
investigational new drug (Nitric Oxide / Nitrogen gas mixture), now an approved new drug. Prior
to working for BOC, John worked for Avon Products and Johnson & Johnson in both production and
Quality Assurance positions.
Since 1984 John has been an active member in the Compressed Gas Association (CGA), previously
chairing its Medical Gases Committee and Medical Division as well as serving on CGA's Board of
Directors. He is the recipient of CGA's 1992 Service Award for his work in coordinating the first
CGA/FDA joint training seminar for medical gas companies. Since establishing Gas Regs, Inc, John
has taken part in public medical gas training seminars and has shared the podium several times
with FDA officials. John is a member of the Regulatory Affairs Professionals Society (RAPS), Food
Drug Law Institute (FDLI), American Society for Quality (ASQ), Association of Food and Drug
Officials (AFDO) and its regional organization CASA, the Institute of Validation Technology (IVT),
the American Association for Homecare, and the Pennsylvania Association of Medical Equipment
Suppliers (PAMS).
Mr. Willenbrock holds a BS in Chemistry from Bucknell University, and is Regulatory Affairs
Certified (RAC) by RAPS through examination and recertification. In addition to formal education
and certification, John remains current on FDA regulatory and QA issues through attendance at
seminars and workshops in these fields.
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