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
April 19, 2024
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: 10:00 AM PDT | 01:00 PM EDT
By: Alan M Golden
May 10, 2024
Validation Statistics for Non-Statisticians
In this program, we will discuss the common statistics tools and techniques used in validation. Through real-world examples and interactive exercises, we will demonstrate the basic concepts of sta…
Industry: Medical Devices Duration: 60 Minutes Time: 10:00 AM PDT | 01:00 PM EDT
Chronicles
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
By: Alan M Golden
Recorded Session
Design Control for Medical Devices and Combination Products
This Webinar will outline the basics of design control for medical devices and the device part of a combination product. Failure to develop these products under design control may result in a prod…
Industry: Medical Devices Duration: 60 Minutes