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Pharmaceutical Development, Design of Experiments
Expert J. Expert has spent many years applying organic chemistry to solving problems in the fine chemicals and pharmaceutical industry. Expert has been involved for many years in developing chemical processes for the fine chemical and pharmaceutical industries. Expert has…
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…
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,…
Cleanroom Technology
Expert has applied his background in the clean room industry to help those clients who are considering the use of clean rooms for their manufacturing process. He can assist with material alternatives and equipment selection that best fits into a…
Laboratory Management; Quality Assurance/Control
Expert has demonstrated expertise with the design, development, and start-up of laboratory facilities. These facilities have been used for analytical testing, physical characterization, environmental sample conditioning, and drug stability testing. He has specified and implemented purified water systems, sample conditioning…
Registration of Drugs, Medical Devices, Cosmetics,Borderline Products; Reimbursement, expert witness
Expert has more than 30 years experience in the registration of ethical and OTC pharmaceuticals. He has worked with solid dosage forms, aerosols, sterile injectables, vaccines, topical products, and biotechnology products. He has registered new chemical entities, novel dosage forms,…
Animal Models, Preclinical Testing, GLPs, Protocols, Data Capture Forms, Veterinary Medicine
Expert has a significant amount of experience with developing animal models through discussions with cross-functional groups and considerable expertise in veterinary surgery and biomechanics. He has experience with animal models for the cardiovascular, peritoneal, gastrointestinal, cutaneous, reproductive, urinary, and skeletal…
Supercritical Fluid Technology
Expert M. Expert has extensive experience in the theory and practical use of capillary GC. He has considerable knowledge in multidimensional strategies, troubleshooting, capillary column technology, injector designs, detection schemes, and current applications. He has also conducted many training courses…
High Purity Process Engineering
Expert specializes in providing independent technical services to critical process industries such as manufacturing of pharmaceutical products and other specialty chemicals where high levels of purity must be maintained. WATER-TREATMENT FILTRATION PROCESS; CONTAMINATION CONTROL. Expert provides support in process development,…