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Edward Oppenheimer, Ph.D
 

edward@cGxP.com

http://www.cGxP.com

25 Harbor Drive., Suite101

Vernon Hills, IL, 60061

Practical Compliance Solutions

 (847) – 549- 0626 ext.225

 

 

Dr. Oppenheimer is an experienced quality control/quality assurance senior executive with 29 years of background in pharmaceuticals (sterile and solid dosage), biologics, bulk chemicals, nutritionals, cosmetics, natural products, and medical devices. Dr. Oppenheimer’s strengths include resolving domestic and international regulatory issues, ISOISO-9001 and EN-46001 certification, project management, the rehabilitation of non-cGMP operations at multiple sites and plants and the organization and direction of R&D and QC/QA systems in domestic and international settings. He also obtained registration procedures for numerous products in Europe, Latin America, Middle-East and Asia.

For numerous products, Dr. Oppenheimer led: Product development, project management, design, construction, start-up, Organized validation programs (production and laboratory); Organized QA/QC (biological, microbiological, chemistry) functions, calibration (plant and laboratories) documentation systems, training, etc. Also responsible for clinical development, drafting of applications and CMC sections for new presentations. Dr. Oppenheimer received his D. Ch., 1969 Mainz University, Germany. B.Sc., 1964 Chemistry, City College, New York, New York.

 

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