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 supply chain can be challenging.

Why Should You Attend:

Companies in the pharmaceutical and medical device space are required to have control over their supply chain and suppliers. Suppliers make changes to their product, production or location on a routine basis. The manufacturer needs to assess the impact of those changes on their product and or production before introducing the vendors product into their manufacturing process. This webinar will discuss setting up good supplier agreements so change notifications are received and how to do a proper impact assessment of those notices before accepting altered product.

All companies in the pharmaceutical and medical device space are required to have control over their supply chain and suppliers. Inadequate assessment of changes to supplier material, production or location can have impact on final product, process and/or regulatory impact. This training will highlight ways to assess the impact of supplier changes to help mitigate impact.

Areas Covered in the Session:

Regulatory Expectations

• FDA
• ISO

Supplier Agreements

• Continuing guarantee statements
• Supplier Change Notices

Assessments of Supplier Change Notices

• Procedures
• Team
• Triage

Types of changes

• Low/No Impact Changes
• All other changes
• How to determine which is which

Full impact assessments of changes which do not fall into the Low/no impact category

• Level of work based on risk
• Team approach
• Tools

Determination of acceptability of change

• Acceptable change
• What to do if change is not acceptable

Who Should Attend:

• Quality Assurance Departments
• Regulatory Affairs Departments
• Production Departments
• Supply Chain Departments
• Technical Scientists

Course Director: ALAN M. GOLDEN

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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. 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.