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Life Sciences, Lab IT Support & Validation
Worked as a group leader as well as R & D Sr.. scientist. Expertise in analytical method development and testing. Worked with NDA and ANDA products with different clients. Directly communicating with clients regarding progress and any problems in development…
Intellectual Property and Patent Litigation, Shoe Industry, Footwear Design Matters, etc.
Expert has a life long history and involvement in intellectual property and shoe design, asmore fully set forth in her resume. She has desinged shoes for the leading US, German, Italian and UK shoe companies and has served as an…
ERP Software Implementation
Expert has played a critical role of helping organizations in choosing ERP software, coordinating implementation, deploying change management, establishing PMO (project management office) and continuously support the on-going day-to-day IT operations and address their evolving needs. Computer Software Project Management…
Cleanrooms, Contamination Control, Ultrapure Media, Qualification and Validation, GMP, AMC
Expert has been active in aersol physics for more than 25 years. His PhD covers also the areas of environmental, indoor and cleanroom aerosols. He worked in a variety of scientific and technical projects covering the health effects of particles…
Internet, Ecommerce, Advertising, Search, Data Mgmt, Business Intelligence, Forensics, Mobile Apps
Expert has over seven years of professional experience in business intelligence, data warehousing and data integration with three patents granted in the areas of data transformation (ETL) and metadata. He has used and is familiar with number of products from…
Rubber, Polymeric Materials, Design, Testing, Production Evaluation, Processing
Expert joined the rubber industry in 1969 after he graduated from the University of Massachusetts, Lowell with a B.S. Degree in Plastics Engineering. He has held various positions throughout his career involving laboratory management, compound design, process evaluation, process and…
Hand Injuries, Hand Tool Design, Ergonomic Issues, Work Related Injuries in Dental/Medical
Expert is a certified associate ergonomist. Expert is founder and owner of a nationally based ergonomic consulting firm. Expert's background in ergonomics has allowed her to utilize her skills in preventing work related accidents and in assisting with the development…
Orphan Drugs: FDA/EU/Canada; FDA Approval; Drug Development: CMC, QA, QC, Manufacturing
12 product approvals from FDA including 6 new chemical entities, a 510k device, and three major pharmaceutical efficacy indication supplemental approvals. All received 5-10 years of regulatory exclusivity (Hatch-Waxman, Orphan Drug). These products are generating over $100 million dollars in…
Drug & Device Clinical Development, Regulatory Approval, Adverse Reactions, Expert Witness
Clinical Pharmacology is the scientific discipline that brings science to the process of drug development, particularly at the key stage where a molecule of interest becomes a drug candidate. From this point, through the rest of Development, the science of…
Agent Standards of Care and Practices, Agency Standards of Care and Practices, Broker Standards of Care, Commercial Insurance, Property Casualty Insurance, Claims Handling and Management.
Expert has over 25 years experience in all areas of placing commercial property/ casualty insurance. His 7 year's of training at national insurance brokerage firm's was instrumental in Expert developing a keen understanding of casualty insurance coverage combined with gaining…