Change Impact Assessments: How to fix something and not break everything else

When:  Jun 19, 2023 from 06:30 PM to 07:30 PM (CT)
Associated with  Milwaukee Section

Zoom Meeting Link:

Meeting ID: 889 6668 2339       Passcode: 019474


In life as well as in the medical device industry, change happens. One of the only things you can guarantee about the development of a new product or the support of that product post launch is that something will change. 

In the medical device and pharmaceutical  industries, unlike life, there are some rules about how you handle change, and the regulatory and product governing bodies have some very specific ideas about how you manage changes to your product. 

This talk will outline ways to look at the impact of changes to ensure that the change is appropriate to its purpose and to ensure that the change does not break any other product or process.

Speaker Bio:

Alan Golden, MS is the @Principal of Design Quality Consultants, LLC

Alan 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 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 of and his MS degree in Molecular Biology and Immunochemistry from the .