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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…
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…
Food Safety, Nutrition, Regulatory Matters, Health and Wellness, and Business Strategy
With experience in the public and private sectors, Expert provides advice and guidance on a wide range of topics. She has senior experience in health and wellness, business strategy, product development, regulatory compliance, food safety, quality systems management, supply chain,…
Biomaterials, Biotechnology, Medical Devices, Polymer Chemistry, Biomedical Engineering, Materials Engineering, Healthcare (regulatory), Intellectual Property Strategy
Expert has more than 20 years experience in biomaterials and medical devices, both in industry and as a university professor performing research. His research has a translational focus, so he has conducted numerous pivotal animal studies related to the fields…
Consumer Product Safety, Regulatory and Retail Compliance, Quality Assurance
Expert is a consumer product (non-food) safety, regulatory and retail compliance, quality assurance and control, 3rd party lab testing / inspection / auditing, CPSC (Consumer Product Safety Commission), CPSIA (Consumer Product Safety Improvement Act), Federal / State / Local compliance…
Transportation Infrastructure, Design, Construction, Maintenance, Funding, and Regulatory Issues
36 years of experience in delivering infrastructure improvement programs and projects. Expert is currently retired, but volunteering, to serve as an appointed Transportation Commissioner. Expert was most recently Deputy District Director of Construction at California Department of Transportation from 2009…
Medical Devices, Business Development, Regulatory Affairs, Project Management
Expert successfully launched over 25 new instrument and disposable medical devices. He developed and managed numerous cross-functional and cross-cultural new product and process teams. He has developed rich experience in team leadership and assembly, grounded in RA/QA fundamentals (RAC Certified).…
pharma, regulatory, cosmetics, biosimilars
The expert is having a post-graduate degree in pharmacy which is duly recognized by the University of Toronto and is currently working as Senior Regulatory Associate at the apex drug regulatory body in India i.e CDSCO. He is responsible for…
Medical Device Business Development, Clinical Trials and Regulatory Strategy, Cardiology, Cardiac Electrophysiology
As a board certified electrophysiologist, Expert has extensive experience implanting and evaluating pacemakers. In addition, she was responsible for regulating pacemakers while at the FDA. Several of her publications are in the area of pacemakers. She is a board certified…
New Ingredient Product Development, Regulatory/ Compliance, OSHA/EHS, Thermal/ Non-Thermal Processing
Experienced Food Science Technical Professional with a track record of improving results in varied food manufacturing environments. Highly motivated team builder/player. Able to provide clear, strategic direction on Food Safety issues. Well-versed in Quality Assurance, Regulatory Affairs, Purchasing, Food Safety…