Alan M Golden
Alan M Golden has over 30 years of experience in the medical device industry, both in basic research and 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 Webinars
By: Alan M Golden
Nov. 9, 2026
Validation Statistics for Non-Statisticians
Validation work depends on statistics, but you don't need to be a statistician to use the core tools well. This 60-minute validation statistics webinar explains the common techniques through real-…
Industry: Medical Devices Duration: 60 Minutes Time: 12:00 PM PDT | 03:00 PM EDT
Chronicles
By: Alan M Golden
Recorded Session
Validation Sampling Plans
Validation sampling plans need to be statistically justified, and the acceptance criteria that go with them have to stand up too. This 60-minute validation sampling plans webinar shows how to set …
Industry: Medical Devices Duration: 60 Minutes
By: Alan M Golden
Recorded Session
Impact Assessments For Supplier Change Notices
A supplier change notice can affect your product in ways that aren't obvious at first. This 60-minute webinar on impact assessments for supplier change notices presents strategies and tools for ev…
Industry: Medical Devices Duration: 60 Minutes
By: Alan M Golden
Recorded Session
Design Control for Medical Devices and Combination Products
Medical devices, and the device part of a combination product, must be developed under design control. Without it, you risk a product that does not suit its intended market or that regulators will…
Industry: Medical Devices Duration: 60 Minutes