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 evaluating them thoroughly.

You'll learn how to decide whether a notice needs a full impact assessment and when lower-impact changes can be accepted or rejected without one. The session covers who should sit on the impact assessment team, which skill sets they need, how often to meet and how to evaluate notices, including verification and validation of the change.

It also highlights supplier and quality agreements with vendors, risk-based approaches to assessment, what happens if a change is unacceptable and how to set up incoming material specifications.

• Explain what supplier change notices are and why they matter to regulators
• Categorize change notices based on risk
• Set up a change impact team with the right skill sets
• Use supplier and quality agreements to require and manage change notices
• Respond when a supplier change is unacceptable
• Set up incoming material specifications

• Introduction to supplier change notices
• The regulatory impact of supplier change notices
• A risk-based approach to categorizing change notices
• Key skill sets for evaluating change notices and setting up a change impact team
• Verification and validation of supplier changes
• Key tools for impact assessments
• Supplier agreements and supplier or vendor quality agreements
• What happens if a change is unacceptable
• Setting up incoming material specifications

Pharmaceutical and medical device manufacturers are responsible for the quality and source of every incoming material. If a supplier change isn't evaluated properly, it can cause failed manufacturing runs or nonconforming product reaching the market, and FDA expects manufacturers to control incoming materials, so poor assessments can lead to enforcement action or recalls.

The session suits QA, regulatory affairs and supply chain professionals, technical scientists and production staff.

• QA professionals
• Technical scientists
• Production staff
• Regulatory Affairs professionals
• Supply chain professionals

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.