Find an Expert
Medical Device Sterilization, Medical Device QA, GMP Audit, Supplier Audit, SOP\’s
Expert, Consulting Principal, is highly regarded in the medical device and sterilization industries. Areas of expertise include: medical device sterilization (Radiation and EO), quality systems development and assessment, sterilization management, medical device regulations, supplier auditing, internal auditing, nonconformity investigation and…
Sterility Assurance Expert in terminal sterilization (Ethylene Oxide, Moist Heat, Radiation, Dry Heat) and Aseptic Processing to Medical Device and Pharmaceutical companies.
. Expert is President and Principal Consultant for his consulting company - a consulting LLC. Prior to going into consulting, he was Director of Corporate Quality Technology/ Sterilization Science, for Alcon a Novartis company where he was responsible for sterilization…
Medical Devices, Biotech, Aseptic Processing, Engineering, Facilities, and Sterilization
Expert has extensive expertise in all areas of aseptic processing and terminal sterilization of medical devices, human tissue for transplanation processing, microcontamination and controlled environments. He has been involved in clean room projects for Ethicon, Inc., Osteotech, Inc., Manufacturing Automation…
Medical Device Design, Simulation and Development
Expert has 25 years of industrial experience in medical devices, consumer products, automotive, robotics, cutting tools and machine tools. He has helped companies to launch 200+ products, published several papers, patents, and chapters in books. His expertise is in medical…
Operating Room, Sterile Processing, and Surgical Practices
Experienced clinical leader with a successful record of leadership, experience and achievements advising medical device manufacturers, developing and implementing field-based sales/product training for sales reps, corporate clinical training, and continuing education workshops for medical/hospital staff and surgeons. Expert in Operating…
Materials Engineering, Polymers, Metallurgy, Chemistry, Corrosion, and Adhesion Science
Expertise in chemistry, materials science, metals, polymers, corrosion, coatings and packaging. Expert has over 20 years of experience working as a technical consultant in materials engineering, polymers, metallurgy, chemistry, corrosion and adhesion science. She has been an advisor to companies…
Pharmaceutical Science; Preformulating, Development, Chemistry, Manufacturing & Control (CMC) Issues; Paragraph IV Hatch-Waxman & Canadian Notice of Allegation
As the development of a pharmaceutical reaches Phase 3, prior to submission of an NDA, method validation is required. Validation is a demonstration of optimization. By demonstrating the capacity of a method within the bounds of validation, optimal conditions for…
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…
Sterile Processing Technology
Expert’s formal training and industrial experience have provided him a solid foundation to design optimal heat sterilization processes for foods, pharmaceuticals, devices, biologics, and equipment. His activities in this field include low-acid canned foods, in-container or terminal heat sterilization of…