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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…
Statistical Analysis, Market Research, Clinical Trials,Marketing Mix Models,Pharmaceuticals,DOE
CLINICAL TRIAL: Expert has over 20 years experience in the statistical design and analysis of clinical trials of health care products. His experience includes working with both pharmaceutical and over-the-counter products. His recent analytical work has included preparing clinical trial…
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…
Records Management, Information Governance, International Record Retention, Digital Document Management, Email Management
Records Management; Document Management; Electronic Records: For over 40 years Expert has been involved with records and document management activities as a professional practitioner, consultant, teacher, researcher, and writer. He has extensive experience developing information and records management policies, strategic…
Process Control, Systems, and Optimization
Most recently Expert’s work has centered on pharmaceutical batch processes requiring Food and Drug Administration (FDA) software and hardware validation. Expert notes that generally, this requires a data model (both procedural and physical) following the guidelines of ANSI/ISA S88.00.02 and…
Physical Chemistry of Food & Drugs
FOOD CHEMISTRY; FOOD DRYING. Expert is a recognized authority in the physical chemistry of the stability of dry and semi-moist systems including foods, drugs, and biologies. His major research areas deal with the effect of temperature and are properties of…