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Alan M Golden

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Alan M Golden

Alan M Golden has over 30 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 16 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 wherein 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.

Live Webinar

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By: Alan M Golden

Aug. 22, 2022

Impact Assessments For Supplier Change Notices

This webinar will discuss dealing with supplier change notices. Regulatory agencies have the expectation that a manufacturer has control over its supply chain and dealing with changes to that supp…

Industry: Medical Devices   Duration: 60 Minutes   Time: 12:00 PM PDT | 03:00 PM EDT

Recorded Session

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By: Alan M Golden

Recorded Session

Validation Sampling Plans

This webinar will discuss setting up statistically justified sampling plans for process validation. The discussion will also involve using the sampling plan to set acceptance criteria for process …

Industry: Medical Devices   Duration: 60 Minutes