Supplier and Service Provider Controls: FDA Expectations

Overview:

This webinar will provide the regulatory requirements (US) of 21 CFR Section 820.50 (Purchasing Control) for the Medical Device industry and provide you with examples. It will furnish details on what should your Purchasing/Supplier Control management system address.

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.

Why should you Attend: This webinar will compare GHTF Guidance (GHTF/SG3/N17:2008) on Control of Products and Services Obtained from Suppliers VS 21 CFR Section 820.50 Requirements. At the end of this webinar, there will be challenges and conclusion sections.

Areas Covered in the Session:

• 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

Who Will Benefit:

• Regulatory Compliance Professionals
• Quality Assurance Professionals
• Quality Control Professionals
• Supply Chain Personnel
• Regulatory Affairs Professionals
• Regulatory Compliance Professionals
• Complaint Handling Professionals

Speaker Profile
Vanessa Lopez - Sr. Principle Quality, Regulatory and Compliance Consultant. She 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 and Company, Pall LifeSciences, among others.