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.
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.
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
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.
DAY 01(8:30 AM - 4:30 PM)Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
Part A – Overview of a Supplier Qualification Program
Part B – Regulatory Framework for Suppliers
Part C – Requirements and Potential Suppliers
Part D – Supplier Evaluation and Selection
DAY 02(8:30 AM - 4:30 PM)Part E – Placing Purchase Orders
Part F – Receiving Product and Services
Part G – Supplier Monitoring and Measuring
Part H – Supplier Re-evaluation
End of Workshop