Staying abreast of ever changing regulatory requirements with the FDA is not easy. In November 2016, FDA finalized their guidance on contract manufacturing arrangements for drugs, detailing their expectations for quality agreements. The final document outlines specific steps manufacturers should make to ensure their contract organizations are living up to a higher standard of compliance. Additionally, the guidance gives contractors a better understanding of what they really need out of their end of a quality agreement, thus helping them to better position themselves as a viable partner. Finally, this gives both parties a roadmap to potential inspection/audit points to be aware of.
Don’t wait until an FDA inspection to learn there are deficiencies with your approach to drafting and implementing Quality Agreements!
This course will provide an overview and discussion of significant portions of the guidance, where you will learn:
- Scope & applicability of the guidance: Defining the who and what of contract manufacturing
- What a quality agreement is – and is not
- Significant areas of focus for contract manufacturing arrangements
- FDA’s perspective on roles and responsibilities – including the first enforcement action highlighting this guidance and other examples
- Action plan: A guide for assessing your current quality agreements