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Medical Device Quality Assurance and Regulatory Compliance
Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…
Medical Devices, Pharmaceuticals, CMC, Regulatory Affairs, R&D, Design Controls, Autoinjectors, Syringes, and Manufacturing
Expert has extensive experience in Pharmaceutical and Medical Device industry. He managed multiple departments and spearheaded combination product activities to launch products. This included FDA/EMA meetings, Human Factor activities, Device Design and Development, Regulatory submissions, and Manufacturing responsibilities. He has…
Consumer Product Labeling
Expert has over 20 years experience in ensuring consumer chemical label compliance under US, Canadian, European, Australian, and New Zealand consumer chemicals regulations; and OSHA Hazard Communication labeling requirements. He will advise on all elements of the Fair Packaging and…
European Chemical Regulations (CLP, Biocid, REACH, etc.)
Expert in European Chemical Regulations, such as the REACH regulation. He intervenes to support business in the European Union and to avoid any chain disruption for non-EU companies. He also acts in Public affairs to anticipate the impact of future…
Supply Chain Track & Trace (Pharmaceutical, Food, CPG). Highly experienced Consultant / Program mana
Expert specialized in the field of supply chain with particular emphasis on traceability of pharmaceuticals, medical devices, food and cosmetic from production to point of dispensing. He provides a Definition of a global strategy concerning supply chain optimization, track &…
Furniture, Seating, Carpets, Flooring, Domestic and Contract
Expert works in close liaison with clients and appointed professionals from survey to completion. He and his company have a reliability record in place spanning over 40 years. His projects range from a single item to meet a specific task…
Cold Process Soapmaking: Developing Countries, Workshop Design to Product Formulation
Safeway UK once threw Expert the challenge of creating concepts for 30 new varieties of soap in 24 hours. These soaps were in their stores within 3 months of that conversation. As the author of 26 books, 'creative origination' is…
Industrial Woodworking Machinery, Saw Safety, Accident Investigation, Expert Witness
Expert has 33 years of experience in the industrial woodworking machinery arena. His expertise has been in machine design, machine manufacturing and management. He is proficient in each area and demonstrates a wide range of technical knowledge and management skills.…
Usabililty Analysis, Human Factors, Premises & Product Safety & Liability
Ms. Expert has an extensive background in Human Factors, Ergonomics, Usability, and Research Psychology, totaling over 25 years of experience. Her career began in aviation and aerospace where she worked on the design of displays & controls for military and…
Environmental Compliance, Pollution Prevention, Health and Safety, and Fire Loss and Prevention
Expert has extensive practical knowledge and experience in the field of pollution prevention technologies. He has performed numerous pollution prevention audits internationally resulting in millions of dollars in waste minimization, energy and feedstock material savings for clients. He has worked…