Qualification and Management of CMOs (Contract Manufacturing Organizations)

Duration: 12 Hours
Course Instructor

Frank Carroll

$ 2330
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

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Every pharmaceutical company hopes to obtain its desired expectations when it comes to important relationships with their outsourcing partners. This intensive course examines the root causes of critical issues that can arise within these relationships, which are much broader and deeper than the technical capability to perform a process.

This course examines the strategic and tactical outsourcing processes of selecting, monitoring, and managing an outsourced operation. It includes a review of domestic and international regulatory requirements and operational aspects including the role of the quality system. An in-depth discussion of risk-based supplier and material qualification processes, supplier selection, supplier monitoring, contracts/agreements, and auditing will be presented.

In addition, we will cover how best practices in project management can transform an outsourcing schedule into a true project plan. 

The live course includes hands-on workshops in which mini teams analyze case studies and present their findings.

Upon completion of this course, you will be able to:

  • Implement effective methods to evaluate potential CMO’s and other critical suppliers
  • Compare and contrast the multitude of regulatory requirements in outsourcing pharmaceutical operations
  • Organize and implement an effective supplier/CMO qualification program based on risk management principles
  • Implement project management “Best Practices” in outsourcing
  • Recognize, determine the root cause, and improve common contractor/client relationship conflicts
  • Apply Risk Management techniques to identify, prioritize, avoid and mitigate contractor risks
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This course has been designed for those who need to select, implement, improve, and/or manage Contract Manufacturing Organizations in the pharmaceutical industry as well as the biological, device, diagnostics and cosmetics industries. It will be of particular interest to individuals in:

  • Corporate & Operations Management of “Virtual” Organizations
  • Manufacturing
  • Supply Chain Management /Project Management
  • Packaging
  • Process Development
  • Engineering
  • Regulatory Affairs
  • QA/QC
  •  Managers of CMOs, Contract Development & Manufacturing Organizations (CDMOs), and Contract Research Organizations (CROs) including Managers of combination products

Individuals within R&D who outsource any of their functions and face many of the same challenges with Contractors would additionally benefit from this course.

Course Instructor


Frank Carroll

Director, Supply Chain and Facilities, Zosano Pharma/ZP Group LLC

Frank Carroll’s Courses


Team Training

When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.

Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.

In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.

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