Technical tools and knowledge required to operate and manage in medical devices manufacturing environment. Current requirements in medical devices regulations, quality systems, and design elements related to manufacturing steps to assure patients health and safety. Requirements concerning selection and supply of raw materials and components for manufacturing; design and qualification of facilities, equipment, and process systems; testing, controls and inspection for compliance. Combination products, validation, external contractors, and case studies. Focus on understanding the principles and methods required in a medical devices manufacturing environment in compliance with GMP regulations.
ME 585:Good Manufacturing Practice in Medical Device Facility Design
Focus of the course is compliance requirements necessary for Good Manufacturing Practices and Quality Management System. Background includes familiarization of the different categories of medical devices and their manufacturing special requirements. Manufacturing facility requirements are then presented, noting major differences between the various classes of medical devices and also within the classes (e.g. sterility requirements or cleanliness). Included are special requirements for combination products. Regulatory requirements are reviewed. The core of this course is the good engineering practices of facility design. This includes conceptual design, basic engineering, scale up (from lab to manufacturing), procurement, construction, key technologies such as HVAC and utilities requirements, and commissioning, qualification, and validation. Calibration, re-qualification, and maintenance are covered for optimal operational efficiency. Case studies of various manufacturing facilities will be presented.
Daniel De Grande holds a BSc in chemical engineering from the University of Louvain (Belgium – Europe) and has completed post-graduate studies in quality engineering, project management, microbiology and sterilization processes.
Daniel has acquired thirty years of experience in the bio/medical/pharmaceutical world, working in different positions and for different employers : he was first product and process development engineer for Baxter, he did marketing development and organized QC laboratory for Terumo, he was head of process engineering and maintenance for GlaxoSmithKline Biologicals and created and headed the Quality Assurance department of Federa, a major contract manufacturer located in Brussels, specialized in the aseptic filling of syringes and ampoules. Daniel pursued is carreer as plant manager for UCB Bioproducts and Eurogentec, companies specialized in the synthesis of Peptides and finally he was managing director of Besins Healthcare, a company producing sexual hormones compounds.
Daniel is also since 19 years an active ISPE member of the international Education committee and a board member of the ISPE Belgian affiliate group. Daniel has given a large number of lectures in the field of pharmaceutical and medical device manufacturing he was course leader of several conferences and congresses. His main activity since one year is dedicated to the teaching of modern bioscience technology.
