Pharmaceutical Contract Manufacturing Organizations (CMOs) have become increasingly prevalent due to the globalization of the pharmaceutical supply chain. While utilizing CMOs offers numerous advantages, it also introduces distinct compliance risks, especially given that operations are not directly controlled. Notably, FDA Warning Letter trends highlight compliance and data integrity issues at foreign CMO sites, emphasizing the significance of these risks.
When engaging CMOs, your company bears full responsibility for product quality, safety, efficacy, and cGMP compliance. The FDA has clearly stated that firms utilizing CMOs are accountable for ensuring their compliance with cGMPs and regulatory commitments. Any issues identified at the CMO can lead to FDA 483s and Warning Letters directed at your firm. Thus, establishing a robust CMO management system becomes imperative to ensure proper quality oversight, uphold product safety, and maintain compliance.
Why You Should Attend:
This seminar focuses on equipping personnel responsible for CMO oversight with the necessary knowledge to effectively ensure quality oversight throughout the entire CMO engagement process. It covers essential aspects such as Selection and Qualification, CMO Audits, Quality Agreements, Oversight of CMO Operations, and Review of Key CMO Records. The seminar also addresses considerations for different manufacturing types and offers techniques for managing challenging CMO situations. Additionally, it explores strategies for maintaining robust CMO Oversight programs amidst COVID-19 restrictions.
Delivered in a practical how-to format, this course empowers participants with actionable skills applicable to CMO oversight in their respective organizations. Engaging case studies provide opportunities to practice these skill sets under the guidance of the instructor.
|DAY 1 (10.30 AM to 3 PM)||DAY 2 (10.30 AM to 3 PM)|
|The CMO Business Model|
What is CMO Oversight?
CMO Oversight and COVID-19 Restrictions
Regulatory Requirements for CMO Oversight
FDA Expectations and Warning Letters
Structuring Your Organization for CMO Oversight
CMO Selection and Qualification
CMO Audits (Remote Auditing Perspective)
The Quality Agreement
Getting to Know Your CMO
Review of Key CMO Records
Hot Topic - Data Integrity Latest Updates
Ongoing CMO Oversight
Who Should Attend: