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FDA Regulatory Expert Witness Regarding Medical Devices, Drugs, Software and Data Integrity
Skilled at writing expert reports that describe and explain regulatory and compliance-related issues involving FDA-regulated companies. Talented in depositions and testimony. Specialist in analyzing drug/medical device-related safety data and FDA compliance information to answer three questions: 1) What did the…
Market Research During Innovation: Quantitative and Qualitative Research in All Industries
Expert has 30 years' experience focused on the innovation process. He possesses a wide-ranging knowledge of market research, market analytics and customer insight tools: ethnography, customer visits, customer requirements, jobs to do, KJ analysis, affinity diagramming, needs identification, sample size…
Industrial Utilities (Equipment, Operation, Maintenance); Energy Conservation; Vibrations
Expert worked as a staff mechanical engineer at what was the world's largest single site producer of PET. The staff supported operations and maintenance departments throughout the facility, with heavy emphasis on the utilities department. Troubleshooting centrifugal pumps was a…
Vascular Access Complications, Infusion Therapy Complications, Professional Training Disputes
MD, Internal medicine, emergency medicine and cardiology,vascular access specialist Education: MD Diploma, foreign graduate, Sverdlovsk Medical School, Sverdlovsk, Russia, US equivalency diploma confirmed by Mayo Clinic, Sverdlovsk Medical College, Sverdlovsk, Russia, Nursing Program Training and membership: Clinical and Interventional cardiology,…
Good Clinical Practice (GCP), clinical trials, regulatory authority inspections, audits, QM
Expert is a former GCP inspector with the German Federal Institute for Drugs and Medical Devices [BfArM]. She has led and conducted GCP inspections on behalf of EMA and national authorities all over the world. Expert has experience in assessing…
Energy, Oil & Gas–Resources, Global Market & Geopolitics | USA, EU, Latin America, China, OPEC
Expert's expertise is the global, market-centered oil-and-gas (O&G) system including both (1.) Consuming and (2.) Producing states: -1.a- Producing countries' O&G sectors. For example OPEC in Latin America (especially Venezuela and Brazil) and OPEC in the Mideast (especially Iran, Iraq,…
Clinical Development, Safety Reviews, Pharmacovigilance, Pharmacoeconomics
• Employer for preparation for an FDA Advisory Committee regarding review of an NDA. • Design and implementation of Phase I-IV clinical studies • Employer to many large pharmaceutical companies • Employer to Biotechnology companies and CROs • Medical safety…
Pressure Sensitive Adhesive Tapes, Release Coating, Laminations (Total Business)
While being a Technical Marketing Manager at Borden, Mystik tape division, and Scapa tape he visited many end use customers to discuss their applications and gained vast knowledge of applications of all different tapes. Having more than 45 years experience…
Injury Biomechanics, Biomaterials, Artificial Joint Implants, Tribology
Expert has applied her mechanical engineering background to biomaterials, biomechanics and nanotechnology for implantable devices in many industries. She has selected surface engineering process coatings, developed new operating procedures to mechanically test biomaterials used for orthopedic and injury biomechanics applications,…
Forensic Psychiatry, System Consultation, and Program Planning and Development Services
Expert has over 25 years of experience providing clinical treatment, case consultation and program planning and development services. He is board certified in general psychiatry and in child/adolescent psychiatry. He has consulted locally and nationally to private businesses, health insurance…