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.
The result is a supplier qualification program that address two principle questions:
- Which suppliers are good enough to start doing business with you
- Which suppliers should continue to do business with you
This workshop explains an overarching supplier qualification program that is common to FDA regulated medical product manufacturers. It also provides the details of the various program areas such as devices, pharmaceuticals, etc.
An effective supplier qualification uses tools and techniques. The workshop explains particularly relevant tools such as supplier audits, metrics, scorecards, acceptance verification, and corrective action. These techniques help make the program FDA compliant and robust.
Why You Should Attend:
An effective supplier qualification program can prevent problems and save money. The goal is to ensure that competent suppliers provide products and services correctly and on time. This saves cost and helps you provide good products to your customers. In addition, an effective supplier qualification program meets the regulatory requirements; you will not need to worry about an FDA 483 or a Warning Letter. This workshop provides the information you need to establish and manage an effective program.
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
Who Will Benefit:
- Purchasing Managers
- Quality Managers
- Supplier Quality Engineers
- Audit Managers
- Compliance Managers
- Law Department Managers