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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…
Digital Transformation: Risk and Engineering
Working with global and international clients and organizations to address emerging, evolving and rapidly changing enterprise risk, governance, risk and compliance, operational risk and resilience, business continuity, crisis management, organizational and digital transformation, as well as control system testing, review,…
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…
Traffic Accident Reconstruction, Motorcycles, All-Terrain Vehicles ATVs/ROVs/UTVs, Industrial Accident Reconstruction, Amusement Ride Accidents, Product Defect and Failure Analyses
Expert has more than 15 years of experience providing forensic engineering services in motor vehicle crash reconstruction to law firms, public defenders and insurance companies; Automotive engineer; worked in the automotive industry for approximately nine years; Board certified Forensic Engineer…
Intellectual Property, Patents, Validity Invalidity, Infringement Noninfringement, Product Liabilty
Expert has extensive experience in product liability which include: Direct participation in more than 300 litigation cases with in-depth evaluations of multiple high-dollar claims and lawsuits. Forensic Analyses. Expert witness reports, inspections, accident reconstruction, photographs, occupant kinematics & injury causation,…
Pharmaceutical Quality Assurance, Quality Control, Supplier Selection and Supplier Quality
Expert has extensive expertise in GMP matters in the pharmaceutical and medical device industries. During his 20 years in industry, he devised, managed and led programs to assure compliance to drug GMPs, GLPs and GCPs. Key areas of expertise included…
Automotive Industry Lean Manufacturing
He has set up new automotive part supplier factories in Thailand and China. He has hired and trained the main plant staff members in each of these factories in areas that include plant quality control, quality systems, inventory control, quick…
Quality Control, Quality Assurance, ISO9000, Forensic Pathology, Products Liability
Expert has over 40 years of progressively increasing experience in business beginning as an electronics technician, production planner, quality control engineer, quality manager, manufacturing manager, director of training and finally as a consultant, senior consultant, expert witness and now a…
Durable Applications for Nonwovens, Quality Management Systems, New Business Development Systems
Has been responsible for global new business development for a leading international nonwoven manufacturer. Has lectured on the Stage Gate process of New Business Development at nonwoven association training course. Responsible for strategic planning for the North American Operations of…
Steel Tube Technology Management, QMS, EMS, OHSAS, TQM, Stretch Target Process/ Product Development
General: Proficiency in the primary areas A post graduate in Metallurgy ( univ gold Medalist) and an MBA with 37 years of primary expertise in the following major areas: 1. Quality Management, Quality Assurance 2. Product and process development 3.…