This webinar will include a detailed discussion of Contract Manufacturing Organizations (CMO) Quality Agreement topics such as change control, documentation, facilities, and equipment, lab controls, sub-contracting, etc. Attendees will learn how to comply with new FDA and EU guidelines for contract drug manufacturers.

Areas Covered in the Webinar:-

• The who and what of a good Quality Agreement
• What a Quality Agreement is - and is not
• Responsibilities of the owner vs. contract facility
• GMP responsibilities
• A comparison of the new guidelines from the FDA and the EU

Frequently Asked Questions:-

• Should the quality agreements be product or service-specific or a blanket agreement should suffice?
• Would a quality agreement be required in cases where CRO purchases material from an intercompany affiliate?
• Clients expect quality agreements with sister sites providing products and services to the host site. What are your thoughts?
• Is the expectation to establish these agreements with all suppliers, or should it be based on vendor risk?
• What is the guidance for agreements b/w CMO and its vendors? Would this apply to CROs also?

Topic Background:-

In 2010, the global CMO market was estimated at 26 billion dollars. Year on year growth has been 10.7% since 2008. The increasing use of outsourcing in the pharmaceutical industry along with recent well-publicized quality issues with CMOs, make it a necessity to have excellent quality oversight of external manufacturers to assure GMP compliance. A Quality Agreement is one tool used to accomplish this objective.

A Quality Agreement is a contract between a pharmaceutical firm and a GMP Contract Manufacturer detailing the responsibilities of each party in assuring the quality, safety, and efficacy of the manufactured drug.

Recently, the EU and the FDA issued regulatory guidance to bring some clarity and consistency to these quality contracts:

• EU GMP Chapter 7 "Outsourced Activities" (Revised)
• Draft Guidance for Industry - "Contract Manufacturing Arrangements for Drugs: Quality Agreements" May 2013

Why Should You Attend:-

Control of suppliers such as Contract Manufacturing Organizations (CMO) has always been a requirement of the FDA and EU. With the issuance of these new regulatory documents, the expectation is that there will be written documentation of this control. Proof of this control can be presented to FDA / EU inspectors in the form of a Quality Agreement that is specific to a particular CMO.

This webinar will provide a thorough understanding of the content that is expected in the Quality Agreement from a regulatory perspective. Each proposed section of a Quality Agreement is fully analyzed and suggested content is written with the new guidelines taken into consideration. A comparison of the two regulatory documents will be presented with differences highlighted and discussed. The latest status of the FDA draft guidance will be discussed and a review of comments from the industry is included.

Who Will Benefit:-

This webinar will provide valuable assistance to all personnel in:

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