2022 - Impact Assessments For Supplier Change Notices

OVERVIEW
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 vendor's 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 products.
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 an impact on the final product, process, and/or regulatory impact. This training will highlight ways to assess the impact of supplier changes to help mitigate the impact.
AREA COVERED
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 that 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 the change is not acceptable
WHO WILL BENEFIT?
QA professionals
Technical scientists
Production staff
Regulatory Affairs professionals
Supply chain professionals
SPEAKER PROFILE
Alan M Golden 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.
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