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Large Animal pharmacology/pharmacokinetics, Sterile products,GMP,Product Development, Safety and ID
Expert has training is antimicrobial monitoring and reporting to Blue Cross/Blue Shield of hospital infectious diseases. She is an occupational safety officer for laboratory animal programs and a pharmacy safety instructor. She has completed GMP training to include auditing in…
Financial Risk Management, Risk, Governance, Regulatory Change Management, Financial Services, and Financial Literacy Coaching and Teaching
A financial services executive, Expert specializes in the development and implementation of enterprise risk management and governance frameworks. She advises companies on aligning mission and strategy with operating models and controls. She also troubleshoots and remediates operational and regulatory issues.…
Fermentation, Scientific and Regulatory Affairs
Expert is dedicated to commercializing novel ingredients for health and sustainability Proficient in human pathology, plant biology, synthetic biology, and fermentation technology. Her specialties include Product Innovation and Formulation, CPG Application Testing COGS and Process Improvement, Food Science, Safety and…
Herpetology, Wildlife Conversation, Zoological Practices, Animal Care, and Biology
Expert founded his environmental consultancy in 1977. The firm specializes in endangered and threatened plant and wildlife species. His consulting company specializes in wildlife inventories, adverse impacts of development projects, and venomous snake and turtle monitoring on construction projects. Most…
UK Water Industry and Regulation Expert
Expert is a Chartered Environmentalist with more than 30 years’ experience in the global water and environment sector, working for a UK Central Government department, government regulators, a water utility, lobbying charity, international professional body (as Director of Policy) and…
Purchasing, Project Management, and Package Design
Expert is a business professional with an MBA in Marketing and a BS degree in Package Engineering, with over 30 years experience, primarily in the food and consumer products fields. In addition, he is a certified ESL instructor. Qualifications include:…
Pharmaceutical Science; Preformulating, Development, Chemistry, Manufacturing & Control (CMC) Issues; Paragraph IV Hatch-Waxman & Canadian Notice of Allegation
As the development of a pharmaceutical reaches Phase 3, prior to submission of an NDA, method validation is required. Validation is a demonstration of optimization. By demonstrating the capacity of a method within the bounds of validation, optimal conditions for…
General Industrial Hygiene; Toxicology; Laboratory Safety; Hazard Communication; Chemical Hygiene
Expert has worked as a consulting industrial hygienist for 24 years. He is both a Certified Industrial Hygienist (CIH) and a Certified Safety Professional (CSP). He has conducted many detailed compliance evaluations/inspections and has developed helpful code interpretations for clients.…
Medical Device & Pharmaceutical Quality Systems; Regulatory. Affairs; Quality Fitness Reviews
Advised and trained Operations and QA employees in a large pharmaceutical plant on effective practices to investigate and document deviation events on the manufacturing floor and quality control laboratory. The aim of such investigations was to determine a root cause…
Metallurgical and Materials Engineering, Problem Solving
While Expert is a degreed materials engineer and licensed metallurgical engineer, he approaches all assignments as problem-solving projects. Whether it be plaintiff-subrogation or defense litigation, manufacturing and quality optimization, accident investigation, or assistance with team accreditation, he applies his background…