🎤  Alan M. Golden      |  📅  June 6, 2024    |  🕒  11 AM Eastern Time US 




Why You Should 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.


Description:

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.

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


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