Description:

This industry is regulated by the FDA and the EU, who both recommend a written Quality Agreement between parties to ensure compliance.Between the increased use of pharmaceutical outsourcing and recent publicized quality issues and deficiencies with some CMOs, it is necessary to have a form of quality control oversight.  This oversight will offer protection from liability as well as ensuring compliance with Good Manufacturing Practices.  The FDA is now recommending a written Quality Agreement between parties. This CMO specific agreement is proof of good intent, and can be provided to FDA and EU inspectors.OnlineAudio will help your organization prepare this Quality Agreement, while giving you a deeper understanding of the regulations and requirements the FDA expects you to fulfill with the agreement itself.

Objectives of the Webinar:

It is vital to understand the new FDA and EU requirements and how they affect your enterprise, how a good Quality Agreement can help with issues that affect liability and responsibility, and what is NOT covered with the agreement.

This webinar will address many aspects of a good, effective and compliant Quality Agreement.

• Quality Agreements will be analyzed and highlighted with suggested content, taking the new guidelines into consideration.
• FDA and EU regulatory documents will be compared and discussed.
• The most up-to-date FDA requirements are discussed, along with comments from the industry itself regarding the implementation of these requirements.
• Understanding who is named in an effective Quality Agreement and exactly what the agreement covers.
• The individual responsibilities of both the owner and the contract facility
• Good Manufacturing Practices (GMP) responsibilities explained
• Other Quality Agreement topics covered in detail, including documentation, facilities and equipment, change control, and lab controls, and much more.

Who will benefit:

This webinar will benefit all levels of management and staff, including:

• Outsourcing and External Manufacturing
• Quality Control and Auditing
• Regulatory Compliance and Affairs
• Technology Transfer