Seminar: 2-Day Virtual Seminar Vendor and Supplier Qualification Program for FDA Regulated Industries When: Wednesday & Thursday May 12-May 13, 2021 DAY 01 (9:00 AM - 5:00 PM EDT) DAY 02 (9:00 AM - 5:00 PM EDT).
The FDA regulates manufacturers of medical products such as devices, pharmaceuticals, tissue products, and biologics. However, the regulations don’t usually extent to suppliers. Instead, the FDA expects the medical product manufacturer to implement an effective program to qualify and re-qualify suppliers for these regulated industries.
An effective supplier qualification program has some specific elements including determining expectations and requirements, identifying potential suppliers, evaluating them, selecting a supplier, and re-evaluating the selected suppliers. When issues arise, the manufacturer communicates with the supplier and manages corrective action.
Participants learn the elements of an effective supplier qualification program for FDA regulated medical products.
Define a sustainable supplier qualification program
Understand how to set expectations and requirements
Learn how to identify potential suppliers
Understand methods to evaluate potential supplier’s for their ability to meet your requirements
Know how to select suppliers based on the evaluation
Learn the requirements to keep records – a key component for FDA compliance
Learn sound methods to specify the products and services from suppliers
Understand how to evaluate received products and services, including statistical techniques
Learn the techniques to monitor and measure supplier performance
Understand how to re-evaluate suppliers and keep records
Learn methods to improve or replace poor performers
Understand supplier qualification tools including audits and performance evaluation.
Contact Person: SAM