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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,…
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…
Analytical Chemistry, Analytical Technology Development and Application
Expert is a Ph.D. Pharmaceutical Analytical Chemist with extensive experience in separations (LC, GC, Prep GC), dissolution, automation (robotics, computers) and general analytical technologies. He has familiarity with NDA programs and marketed product support, including analytical method development, process support,…
Industrial Hygiene, Occupational Health, Hazardous Materials Management, Emergency Response
He championed the implementation of a variety of strategies to reduce workplace accidents and injuries. Strategies included establishment of on site workplace health and safety teams. These teams included both management and labor employees who worked together to identify safety…
Practical Application of GLP, GCP, and cGMP to Pharmaceutical, Device, and Biotechnology Firms
As Vice President at a pharmaceutical company, Expert formulated eight pharmaceuticals for use in their patented buccal delivery platform technology. Five formulations were acceptable to FDA and were allowed to proceed into human clinical trials under IND controls. Four of…
Aseptic Process Design, Airflow Visualization, HACCP, PAI Preparation, Cleaning Validation
Expert has performed validation of aseptic processes including technologies such as blow-fill-seal, high-speed automated liquid and powder filling lines, lyophilization, barrier and isolation technology, and bulk pharmaceutical and biological processes. Expert has developed an airflow visualization procedure to assist the…
Pharmaceutical Product Development, Drug & Medical Device Safety, Regulatory Affairs
Expert is active in U.K. General Practice with wide therapeutic area knowledge and practical patient prescribing. He has a good understanding of the U.K. health system, formulary adoption, N.I.C.E., and reimbursement. Expert has 15 years of experience in the design,…
Veterinary Drugs, Veterinary Pharmaceuticals, Animal Drugs, Animal Pharmaceuticals
Expert retired in 1992 from the FDA after a 29-year career. He spent his career in the FDA as a field laboratory analytical Chemist, a scientific coordinator in the management of Quality Assurance programs for field scientists, a program analyst,…
Health Conditions for International Trade in Fisheries Products, Food Safety, and EU Fisheries
Expert has worked in the Instituto Nacional de Pesca of Ecuador, developing industry codes of practice for processing and handling of farmed and wild-caught shrimp and shrimp products. Assisted with the design and implementation of export certification activities of $450…
Pharmaceutical Development & Validation
Expert has over 20 years of broad-based experience with pharmaceutical product development. His work in this area has ranged from early phase 1 drug characterization to phase 4 market product launch and validation. He has significant experience in bringing products…