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.
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 a written documentation of this control. Proof of this control can be presented to FDA / EU inspectors in the form of a Quality Agreement which is specific to a particular CMO.
This webinar will provide a thorough understanding of the content that is expected in 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. 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 The latest status of the FDA draft guidance will be discussed and a review of comments from industry is included.
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
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
