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Supplier and Service Provider Controls: FDA Expectations - Webinar

  • ID: 4899586
  • Webinar
  • May 2019
  • Region: Global
  • 180 Minutes
  • Compliance Online
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.

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
Note: Product cover images may vary from those shown
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.
Note: Product cover images may vary from those shown