Supplier and Service Provider Controls: FDA Expectations

Supplier and Service Provider Controls: FDA Expectations is an online 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 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 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

Future Events

Supplier and Service Provider Controls: FDA Expectations 2020

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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