Supplier and Service Provider Controls: FDA Expectations


Ms. Lopez has held a wide variety of leadership roles in the Medical Device (Class: 1, 2, and 3), Pharmaceutical (API; Finished Product) and Environmental regulated industries as well as in 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 ........

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. Purchasing and Supplier Control deficiencies have ranked in the top 10 deficiencies related to warning letters. The FDA focuses on how companies are addressing in 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.
Furthermore, 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.

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Webinar Id: LSHCVL001

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Duration: 90 mins

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