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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…
Plastic and Coating Stabilization; Controlled Degradation Analysis and Design; Analytical Services
Expert's knowledge in the area of amorphous and crystalline polymers is based on 36 years in the field, having worked with all commercially available amorphous, crystalline, and semicrystalline resins. His knowledge includes physical properties and stabilization at many levels and…
Medical Device Quick Prototyping/CAD Design/Concepting
Expert (pronounced "munch"; ) has designed and developed a cast base for biometric scanning. This base resulted in stable dimensions and functionality when subjected to change in temperature. Scans were used for both hand and finger use. He developed a…
Biotechnology Product Reviews, Biologics, Drugs & Medical Devices, FDA Litigation, Vaccines, etc.
Over 18 years experience with legal, scientific, business and regulatory issues affecting the research, development and commercialization of biomedical and information security products. Recognized expertise in strategy development, audit and due diligence, outsourcing, and FDA regulatory matters, including consulting for…
RFID, Operations Management, R&D Strategy, Project Management, Supply Chain & Logistics
Expert R. Expert was a pioneer in the "surface mount revolution" where he developed packaging, interconnect, process, and design technologies to enable high volume, small footprint manufacturing of two-way radios, cellphones, and pagers. He has led green field factory development…
Chemical Plant Manufacturing, Process Development, Polyester Polymer, Polyester Film Coating
Expert has extensive experience working in chemical plant manufacturing at several DuPont facilities: Niagara Falls, NY; Victoria, TX; Savannah River, SC; Cape Fear, NC; Sabine River, TX; and Florence, SC. He has always worked in a technical role in manufacturing…
Web Coating Technology and Process Scale-Up
Expert consults in all aspects of the web coating process and has experience in a wide range of coating process and product types. He has over 35 years expertise in the coating and drying of thin films, coating process development…
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…
Thin Film Solar Cell Testing; Semiconductor Optoelectronic Device Measurement and Analysis
Expert has been involved in research and development of amorphous silicon (a-Si) thin film solar cells for 20 years; in this time he has authored or co-authored over 30 papers. He has guided the optimization of device performance from three…
Plastics; Plastic Failure Analysis
Leading expert on the failure of plastic piping including CPVC, PVC, and PEX. Globally renowned expert in styrene polymerization and polystyrene Have extensive experience conducting failure analysis of plastic and composite parts. Have served as an expert witness in about…