FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More

Description

Overview

The FDA requires that manufacturers of pharmaceutical products have a documented process to assess its suppliers and contract manufacturers, that they have implemented that process, and that the process is effective. This training program will explore how having an effective supplier relationship management program will result in streamlining the supply chain, ensuring a more consistent level of quality components, materials and components, and be more cost effective to the manufacturer.

Why Should You Attend:

Failure to adequately assess and control your supplier/subcontractor pool can result in dire consequences for an organization. Assessing and approving your suppliers before placing the first order with them will eliminate many headaches for a medical device manufacturer.

Many organizations conduct supplier audits because they are required to do so by their customers or a regulatory agency. Others conduct the audits because they have been led to believe that it's a good tool for comparing various suppliers against an arbitrary list of criteria.

While all of these reasons have varying degrees of validity, none of them articulate the best reason for having a robust supplier audit program. A good supplier audit program should allow an organization to assess and periodically re-affirm the ability of key suppliers to provide conforming product consistently, reliably and on-time. It should be one of the most important initiatives toward fulfilling the goal of having a sustainable supply chain.

This webinar will provide attendees with the information and tools necessary to develop, implement, and effectively utilize and maintain a program for supplier quality management that will satisfy the FDA’s requirements without creating undue burdens for the organization.

Learning Objectives:

• Understanding the FDA’s requirements for medical device supplier assessment and approvals
• Learning “who” are considered to be suppliers
• Knowing how to structure a supplier quality agreement
• Selecting the potential methods for evaluating and assessing suppliers

Areas Covered in the Webinar:

• Regulatory requirements for supplier qualification
• Responsibilities of manufactures and suppliers
• Best practices for supplier selection, qualification and management
• What are the FDA’s expectations in regards to quality agreements?
• What is meant by the title owner, contractor, adulterated drug, and the term manufacturing within the guidance?
• Best practices for a good quality agreement
• Supplier audits
• Documentation requirements and audit trails

Who Will Benefit:

• Quality Assurance/Quality Control Directors, Managers, and Specialists
• Regulatory Affairs/Regulatory Compliance Directors, Managers, and Specialists
• Purchasing/Materials Management Directors, Managers, and Specialists
• Engineering/Development Directors, Managers, and Specialists
• Document Control Managers and Specialists