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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…
Powders and Tablet Manufacturing
Expert has developed tableting systems and products in the areas of pharmaceuticals, diagnostics, high-protein snack products, chlorine tablets, chlorine removal tablets, over the counter antacids, and vitamins. He has developed sustain release sugar bead systems and also via the use…
Process Control, Systems, and Optimization
Most recently Expert’s work has centered on pharmaceutical batch processes requiring Food and Drug Administration (FDA) software and hardware validation. Expert notes that generally, this requires a data model (both procedural and physical) following the guidelines of ANSI/ISA S88.00.02 and…
Medical Device Total Quality
FDA REGULATION. A significant portion of Expert's career has been devoted to FDA approval and regulation of medical devices, particularily those with significant risk. He is the President of a consulting company specializing in process validation, FDA/regulatory consulting, and auditing.…
Medical Technology
A significant portion of Expert's current activities include maintaining awareness and working knowledge of regulations that impact medical device manufacturers. She has specific experience with new medical device submissions, including combination products. Expert is proficient in total quality systems requirements…
Pharmaceutical Technology, Manufacturing, Quality Systems and Regulations; GMPs and GLPs
Expert specializes in the field of pharmaceutical technology with particular emphasis on the development, manufacture, quality control and quality assurance of pharmaceuticals and medical devices. As a professional consultant to the healthcare manufacturing industries, he works with about 30 worldwide…