36 years experience in the following: 1.Analytical chemistry and microbiology. 2.Quality Control/ Assurance for the pharmaceutical, cosmetic, food, dairy and veterinary industry. 3.Product development and formulation for the pharmaceutical, cosmetic, food, dairy and veterinary industry. (liquid, ointment, tablet, dairy, sauces, candy). 4.Analytical method development and validations. 5.Product stability and efficacy. 6.Occupational safety and health. 7.Coordinator of clinical trials. 8.Author of scientific papers (patents and internal documents) 9.Instrument maintenance and calibrations. 10.Statistical Process Control 11.Supervisory and Management 12.FDA audits and response 1. Took BodyBio Inc. from having no Quality program and a warning letter from FDA to passing FDA inspections and 3rd party NSF inspections of CGMP's for dietary supplements. 2. Brought in house manufacturing of phosphatidylcholine (PC) saving BodyBio thousands and getting rid of a non- compliant vendor. 3. Created and rewrote the majority of SOP's at IGI for the transition of a cosmetic company to a drug company and passed the FDA inspection for Drug CGMP. 4. Co-Inventor in AkPharma Inc patents regarding calcium glycerophosphate (Prelief). 5. Participated in the due diligence of Block Drugs purchase of Beano. 6. Worked closely with Johnson and Johnson corporate quality to bring AkPharma Inc. to their contract packagers standards with regards to Lactaid.
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