Change Control for Existing Products

Stacey Bruzzese welcomes Alan Golden from Design Quality Consultants. Stacey and Alan have a conversation about a wide variety of change control topics.

Alan gives a brief review of the product lifecycle
When does change control start and end for a product?
What should be included in change control SOP?
Is the process of change control vastly different during development and post market?
What are the key drivers for post-launch changes?
What is unique about the review and documentation processes for post launch?
What differs between pro-active versus reactive changes?
What tools can be used for identifying the true effect of a change?
What are the most common pitfalls to change control compliance?

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 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.

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