Supplier and Service Provider Controls: FDA Expectations 2019

Supplier and Service Provider Controls: FDA Expectations 2019 is an event dedicated to regulatory requirements (US) of 21 CFR Section 820.50 (purchasing control) for the medical device industry.

Topics

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

Who should Attend

• Regulatory Compliance Professionals
• Quality Control Professionals
• Quality Assurance Professionals
• Regulatory Affairs Professionals
• Supply Chain Personnel
• Complaint Handling Professionals
• Regulatory Compliance Professionals
• Purchasing Personnel
• Quality Supplier Engineers
• Process Development Personnel
• Manufacturing and Design Engineers