Two Day Workshop: Vendor and Supplier Qualification Program for FDA Regulated Industries (Boston, MA, United States - June 28-29, 2018)

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.

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:

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.

Learning Objectives:

Who Should Attend

Agenda:

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

For more information about this conference visit https://www.researchandmarkets.com/research/6nsdb6/two_day_workshop?w=5

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