Webinar: Manufacturing Quality Agreements — Actionable Top Tips for Ensuring Consistent Success

About This Event

Date:
Wednesday, August 30
Location: 
Life Science Training Institute
Online, KS 00000
United States

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.

In this session, James Meckstroth, ProPharma Group Senior Compliance Consultant, 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.

This online webinar is presented by Life Science Training Institute. Use “ProPharma” at checkout for a 10% discount.