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.
Supplier and Service Provider Controls: FDA Expectations 2019 covers topics such as:
- 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
Supplier and Service Provider Controls: FDA Expectations 2019 intended for:
- 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