CMO Supplier Quality Agreements – How to Comply with New FDA and EU Guidelines for Contract Drug Manufacture

Date	Sep 6, 2018
Time	03:00 PM EDT
Cost	$15755.00
Online

The global contract manufacturing organization (CMO) market in 2010 was estimated to be at $26 billion, increasing by 10.7% since 2008. This increased outsourcing in the pharma industry as well as recent quality issues with CMOs that have been well publicized, has brought out the importance and need for having an excellent quality oversight into external manufacturers so that GMP compliance is assured. Quality Agreement will be used as a tool to accomplish this objective.

Why You Should Attend :
This session is aimed at providing a clear understanding of the content expected in Quality Agreements from a regulatory perspective. Roger will fully analyze each section of the proposed Quality Agreement suggest appropriate content each while taking into consideration the new guidelines. The webinar will also provide a comparison of both the regulatory documents, and highlight and discuss the differences.

Areas Covered in the Session :

• The Who and What of a good Quality Agreement
• What a Quality Agreement is and isn’t?
• Responsibilities of the owner vs. contract facility
• GMP responsibilities
• A comparison of the new guidelines from the FDA and the EU

Who Will Benefit:

• Quality Assurance Departments
• External Manufacturing / Outsourcing Departments
• Quality Auditing Departments
• Technology Transfer Departments
• Regulatory Affairs / Compliance Departments
• Supply Chain Departments
• Purchasing Departments
• Risk Management Departments