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Production and Design of Pharmaceutical Products
Expert Nowaday is working as R&D and QC manager in a pesticides and biopesticides industry. He has 11 years of experience on development and transfer of new pharmaceutical products from R&D into manufacturing. He developed pharmaceutical products as softgel (nutraceuticals,…
Medical Device Design and Manufacture
Expert has over 25 years experience in the conception, design, and manufacture of medical devices. Experience ranges from high volume disposables to low volume implantables. Beginning as a manufacturing engineer responsible for all facets of device development and manufacture Expert…
FDA Regulations, GMP/GLP/GCP Compliance; IND, NDA, BLA, PMA and Product Regulation; Toxicology
Experienced in all aspects of validation and compliance including, GMP/GLP/GCP and part 11. Expert worked for over five years as a reviewer of investigational new drug applications, marketing applications, developing guidance and government policy and supporting approval process. In addition,…
FDA Compliance, Project Management, New Product Development, Validation, Cultural Transformation
Expert has audited many cGMP operations. A good audit starts with a good plan. Before starting an on-site audit, he reviews past audits. He notes indications of possible problem areas and items, if any, that were identified for corrective action…
Commercialization of Scientific Devices, Inventions, Scientific Management Consulting, etc.
Expert has used his experience and knowledge of biochemistry and biophysical measurement to create tools for measurement of clinically significant targets for the biomedical industry. He has developed Drugs of Abuse and many other assays, supported the development of complex…
Pharmaceutical Quality Assurance
He possess thorough knowledge of GMP / GLP regulations like US FDA, WHO GMP, ICH, MHRA, ANVISA, requirements of cGMP documents (SOP’s/ Change controls/ Deviations) as per various regulatory agencies. He had actively participated in various international regulatory inspections (USFDA…
Process Engineering; Project Management-PRINCE2; Process Excellence; Pharma Solid Dosage scale-up
My diverse background includes: . 16+ years of executive management experience with Pharmaceutical and Consumer goods companies such as, Abbott, Pfizer Inc. Bristol-Myers Squibb, Johnson & Johnson, and Procter & Gamble. • Over 10 years experience in Pharmaceutical Development, Engineering…
Quality by Design, Good Laboratory Practices, Intellectual Property Security, ICH and FDA Compliance
As the former CIO of a Fortune 50 product development and commercialization subsidiary, and the executive tasked with building an ISO compliant records management program, Expert has had more than 15 years of experience planning, developing, implementing and then managing…
Semiconductor Industry: Engineering and General Management
Expert has over 25 years experience in engineering management of complex system-on-chip programs, including software development and systems engineering. He has broad experience in marketing penetration, business development, and general management with P&L experience. He has strong industry contacts in…
Nuclear Magnetic Resonance, Application and Development of NMR Technology and Analytical NMR Service
Expert has applied the analysis technique of nuclear magnetic resonance (NMR) spectroscopy to all industrial sectors. In the petroleum sector he has applied high resolution 1H and 13C NMR to refinery products and crude oils, establishing structure performance relationships that…