2020 - Implementing a Robust Supplier Management Program

Part 1 – Review Supplier Management Regulatory Guidance
ISO
ICH
FDA
EU
Part 2 – Elements of a Robust Supplier Management Program
Standard Operating Procedure (SOP) example
Quality Agreement template review
Initial qualification
Onboarding
Monitoring / Scorecards
Development
Phase-Out
Part 3 – Review of Risk Analysis Tools and Recent Audit Observations
Review an example FMEA classifying different suppliers by criticality
Review recent FDA audit observations applicable to supplier management