2019 - Supplier and Service Provider Controls: FDA Expectations

FDA Regulatory Background
Intent of 21 CFR Section 820.50 (Purchasing Controls)
Who is Responsible
Key Definitions
Supplier and Service Providers Relationship with the Manufacturer
Who are the Suppliers and Service Providers
Overall Process of Supplier Quality Activity
What Does 21 CFR Part 820 Require
Document Control Requirements
FDA Tracking Expectation
Evaluation and Selection/ Supplier Management and Qualification/ Questionnaire/ Supplier Audits
Guide to Inspections of Medical Device Manufacturers: Purchasing Controls - 21 CFR 820.50
Communication and Change Notification
Level of Controls
Risk Management/ Assessment
Quality Agreements
Link between 21 CFR Part 820.50 (Purchasing Controls) and GHTF/SG3/N17:2008
GHTF/SG3/N17:2008 Six Phases
GHTF/SG3/N17:2008 Vs 21 CFR Section 820.50
GHTF/SG4/N84-Part 5: Audits of Manufacturer Controls of Suppliers
Supplier Metrics Data Sources and Examples of What Should Be in Your Metrics
Warning Letters and Deficiencies Related to Supplier Controls
Challenges