Impact Assessments for Supplier Change Notices
- Tuesday
- August
- 05
- 2025
Alan M Golden Overview:
Having a robust process to do an impact assessment of supplier changes is critical to control the material coming into your site. In this webinar, we will explore and discuss methods to put systems in place to ensure that all supplier changes that require impact assessments are appropriately assessed and impact addressed. The relevant regulatory topics will be addressed as well as ways to introduce a more robust process into your workflow.
Why you should Attend:
An all too common observation during a regulatory audit or during a product nonconformance investigation is that changes were made to the product through a change from a supplier or vendor that were actually harmful to the product performance or that proper studies were not undertaken to ensure the product continued to meet design goals. Changes from suppliers and/or vendors can have impact across multiple product lines. If not properly evaluated for impact the effect can result in delayed production, CAPA, customer issues and complaints as well as regulatory enforcement issues.
Areas Covered in the Session:
- Introduction to change impact assessments
- Risk based approach to assessment of supplier changes
- Verification and or Validation of supplier changes
- Regulatory Impact of Supplier Changes
- What to do if the change is not acceptable
Who Will Benefit:
The following professionals in the Pharmaceutical, Medical Device, or Combination Product industries with responsibilities in the following areas:
- Quality Systems
- Supplier Quality
- Quality Assurance
- Quality Control
- Change Control
- Engineering/R&D
- Regulatory Affairs
- Manufacturing
Speaker Profile
Alan M Golden has over 35 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 20 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.