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Materials, Processes and Hermeticity Testing of Microelectronics for Aerospace and Medical Implants
He has demonstrated expertise in hermetic sealing and leak testing processes for cavity style packaged microcircuits intended for high reliability military, aerospace and Class III medical implants. He has worked as a hermeticity consultant for prominent military and aerospace companies…
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…
Construction Safety
Expert has over 40 years' experience in worldwide professional safety. His work experience includes tenure as Corporate Safety and Security Director for four Engineering, Design and Construction Management Firms. This work has involved over 600 worldwide construction projects. Additionally, as…
wound healing, burns, clinical research, FDA regulations, drugs, devices, medical writing
Expert provides scientific knowledge and regulatory background to assist companies in the research and development of clinical, animal and laboratory studies designed to promote pharmaceutical drugs and medical device products specializing in wound healing and burn care. Additional Services: •Development…
Parenteral/Sterile Product Formulation Development; Protein Peptide Formulation; Drug Delivery
Former Director, Formulation Research, Hoffmann-La Roche Inc.- primarily parenteral formulation and drug delivery systems – Extensive experience in the areas of formulation, drug delivery and clinical manufacturing - Member of Global Formulation Research Leadership Team – Four successfully launched peptide/protein…
Medical Device Accidents, Surgical Fires, Oxygen Safety, Medical Gas Piping, Failure Analysis
Eng. Expert has been conducting medical device accident investigations for 25 years and product failure analysis for more than 30 years. These failures sometimes involve the actual failure of a metal, plastic, or glass part or a failure of the…
Pharmaceutical Manufacture and Supply in Startup New Product Companies & Acquisition Integration
Expert has successfully developed and led a diversity of complex operations and projects in a variety of cultures and environments. These range from turnarounds and startups of flagship greenfield operations to cross functional teams in world-wide new product launches, and…
Food & Drug Administration Rules, Policies, Procedures for Medical Devices and Pharmaceuticals
Expert is an FDA compliance expert with 28 years experience in the field. He served the U.S. Food and Drug Administration as an Investigator concentrating in compliance for pharmaceuticals and medical devices as well as pre-market development of drugs and…
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…
Medical Device Technology, Design and Manufacturing
Expert is a seasoned engineer with over 25 years of expertise in all aspects of medical device research, product and process development. His major areas of expertise include minimally invasive treatments of vascular disease as well as laparascopic and open…