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Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software
Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, Mexico, Australia, South Korea, and…
Pharmaceutical Quality Assurance, Quality Control, Supplier Selection and Supplier Quality
Expert has extensive expertise in GMP matters in the pharmaceutical and medical device industries. During his 20 years in industry, he devised, managed and led programs to assure compliance to drug GMPs, GLPs and GCPs. Key areas of expertise included…
Quality Assurance
Faced International audit conducted by Pfizer Ltd. Management representative for International audit & WHO-GMP audit. Monitoring the activities of QA documentation for Level 1, 2 &3
Clinical Laboratory Testing, Interpretation, Quality Assurance and Reporting.
Expert was trained in clinical chemistry and toxicology and is a Fellow of the American Board of Clinical Chemistry, Academy of Clinical Biochemistry and has over 19 years experience directing clinical laboratories including forensic (drug testing) facilities. Expert has a…
General Surgery, Trauma, Quality Assurance, Utilization Review, Risk Management
Expert MD,FACS has been in the practice of Surgery for 54 years. Chair Department of Surgery. Retired from practice and now a Med Director for the State. He is double board certified. (General Surgery) (Quality Assurance,And Utilization Review and Risk…
Technical Group Management: Environment Health & Safety, Quality Assurance, Project Management
As the former Director of Engineering for Brown and Williamson Tobacco Corporation, Expert has extensive experience in the management of diverse technical activities. Those activities included engineering design, construction, process development, information systems, process control, manufacturing planning, project analysis, capital…
Product Development, Quality Assurance, GMP Audits, Qualifications, Troubleshooting, Pharmaceutical, Nutraceutical, Production Issues, GMP Compliance, Pharmaceutical Dosage Forms, Quality Control
Expert has more than 24 years of experience Internationally (New Zealand; Australia; Oman, and India) in pharmaceutical formulation plants, Product Development; Analytical development; Scale-up, Technology transfer; Manufacturing, Quality Assurance; quality control (testing and releasing); Lead regulatory audits and meet the…
Quality Assurance, Regulatory Affairs, Marketing and Business Strategy for Life Sciences Industry
He has performed compliance audits to 21 CFR Part 11. He has developed qualification protocols to test systems compliant with 21 CFR Part 11. He has developed advertising campaigns, written copy for advertisements and managed the creative development of advertisements.…
Quality Control, Quality Assurance, ISO9000, Forensic Pathology, Products Liability
Expert has over 40 years of progressively increasing experience in business beginning as an electronics technician, production planner, quality control engineer, quality manager, manufacturing manager, director of training and finally as a consultant, senior consultant, expert witness and now a…
Chemical Analysis and Quality Assurance
She has expertise on Varian instruments ICP-AES; ICP-OES; AAS; GC-MS; NMR; Pelkin elmer ICP-OES; FT-IR; Schimatdzu HPLC; Elementar CHNSO; LC-MS; JEOL EPR; Bruker NMR operation and interpretation of results of various metal containing complexes and compounds of organic nature such…