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Validity : 24th Sep'23 to 04th Oct'23
Alan has over 36 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 26 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents, and published numerous papers and abstracts. Alan then transitioned to a quality assurance role where in both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support, and operations.
Alan’s quality assurance experience extends from design control, change control, risk management, CAPA, process and test method validation, and statistics. He has been lecturing on these topics worldwide for over 10 years.
Alan retired from Abbott in 2018 and now runs Design Quality Consultants, providing training, workshops, and seminars in many areas of quality assurance.
Alan received his BS degree in Microbiology from the University of Michigan and his MS degree in Molecular Biology and Immunochemistry from the University of Illinois.
Overview of Design Control for Medical Devices, with an emphasis on design inputs. Seminar will go over regulations, basic concepts in design control and importance of design inputs and how to write appropriate inputs.