Supplier and Service Provider Controls: FDA Expectations


Instructor: Vanessa Lopez
Product ID: 704844

  • Duration: 120 Min
This training program will provide regulatory requirements (US) of 21 CFR Section 820.50 (purchasing control) for the medical device industry and illustrate the same with examples. It will furnish details on what purchasing/supplier control management systems should address.
Last Recorded Date: Jan-2020


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Why Should You Attend:

Supply chain activities (including, the increase in outsourcing materials, components, manufacturing and services) have become more complex to manufacturers and oversight has become more challenging and complicated. Manufacturers are required to manage carefully their entire supply chain. Purchasing and supplier control deficiencies rank in the top 10 deficiencies related to warning letters. The FDA focuses on how companies are addressing procedures and their actual execution on: selection, evaluation, acceptance criteria establishment, communication process (including change notifications), controlling, and monitoring their suppliers and service providers among other related activities. As a result of recalls, there has been public concern regarding insufficient oversight of the entire supply chain from regulated companies.

This webinar will also compare GHTF Guidance (GHTF/SG3/N17:2008) on Control of Products and Services Obtained from Suppliers VS 21 CFR Section 820.50 Requirements. The webinar includes a challenges and conclusion session as well.

Learning Objectives:

  • Detailed information to help you gain a better understanding of the requirements regarding 21 CFR Section 820.50
  • How does 21 CFR Section 820.50 relate to other quality system elements, the link it has with GHTF/SG3/N17:2008 and comparison between both
  • Details regarding evaluation and selection of suppliers/ supplier management and qualification/ questionnaire content/ quality agreement content/supplier audits/ risk management-assessment tools and more
  • Supplier metrics you can implement
  • Understand some of the challenge

Areas Covered in the Webinar:

  • 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

Who Will Benefit:

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

Vanessa Lopez
Sr Quality Regulatory Consultant, Quality and Regulatory Consulting Services

Ms. Lopez has held a wide variety of leadership roles in the Medical Device (Class: I, II, and III), Pharmaceutical (API; Finished Product) and Environmental regulated industries as well as the Consulting Services industry. She has worked for Edwards LifeSciences, Roche Diagnostics, Eli Lilly, Pall LifeSciences, among others. She possesses over 25 years of experience focused on development, implementation, driving improvements and monitoring of Quality Assurance, Quality Control, Regulatory Compliance, Regulatory Affairs, Quality Systems and Supplier Quality activities. Ms. Lopez has in-depth knowledge, coaches on interpretation and application of US regulations, EU directives, specific country regulations (Japan, Canada, and others), national/international standards and guidance documents. She has also held positions within the CAPA, Material, Safety and Management Review Boards as well as represented Quality in Design Control phases.

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