COURSE DESCRIPTION

OVERVIEW

Quality agreements are an integral part of outsourced GMP manufacturing and testing. They define the framework for quality expectations between you and your vendors and the responsibilities necessary to demonstrate drug quality, safety, and efficacy. In 2016, the FDA issued dozens of 483 observations relating to topics governed by the quality agreement system.  Furthermore, in November 2016, the FDA finalized the “Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry” document.

Due to this new guidance, you can be sure that your firm’s quality agreement will receive increased scrutiny, leaving you vulnerable to the risk of non-compliant GMP products and services if your agreements aren’t clear and enforced.

In this session, industry expert James Meckstroth will provide a fundamental overview of what an effective quality agreement program looks like and how to manage it. Presented from the perspective of active pharmaceutical ingredient and pharmaceutical drug product CMO, James will guide you through a quality agreement framework that may fit into your organization’s vendor/supplier qualification program.

LEARNING OBJECTIVES

After attending the 90 minute interactive webinar, you will be able to:

• Identify FDA regulations and new guidance regarding quality agreements
• Utilize tips to help you manage quality agreements effectively
• Review the pitfalls to avoid when developing your program
• Organize stakeholders, develop a comprehensive document, and initiate
• Implement oversight steps that keep you compliant and on track towards continuous improvement