Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs): 2-Day In-person Seminar

The globalization of the pharmaceutical supply chain has led increased us of Contract Manufacturing Organizations (CMOs). The use of CMOs provides many benefits; however, it can present unique compliance risks, particularly since the operations are not in your facility and therefore not under your direct control. The compliance risks are highlighted by FDA Warning Letter trends, the majority of which are related to serious compliance and data integrity issues at foreign CMO sites.

If you use CMOs, your company has the ultimate responsibility for product quality, safety, efficacy, and cGMP compliance. Furthermore, FDA has clearly stated that organizations using CMOs will be held accountable for CMO compliance to cGMPs, as well as adherence to regulatory commitments. Therefore, issues identified at your CMO may result in FDA 483s and/or Warning Letters issued to your company. Since FDA is holding firms using CMOs responsible, it is imperative that your organization have a robust CMO management system. At the end of the day, your organization’s ability to provide proper quality oversight of CMOs is the key to assuring product safety and your company’s compliance profile.

Upon completing this course, participants should be able to:

• Understand the CMO business model
• Learn the regulatory requirements for CMO quality oversight
• Learn how to structure your organization for effective CMO oversight

This course is designed for people tasked with oversight of these CMO functions:

• Manufacturing operations
• Quality Control operations
• Quality Assurance operations

The following personnel will benefit from the course:

• Pharmaceutical Development
• Quality Control
• Validation
• Regulatory Affairs
• Quality Assurance

Note:
Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:

http://www.complianceonline.com/pharmaceutical-contract-manufacturing-organizations-cmos-seminar-training-80389SEM-prdsm?channel=sciencedz