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Qualification and Management of CMO’s

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Overview / Abstract:

Outsourcing operations to CMO’s has become a critical segment of nearly every pharmaceutical company’s operational strategy, yet few clients or contractors achieve the envisioned expectations of these important relationships. The course examines the root causes of these issues which are much broader and deeper than technical capabilities.

This practical course outlines both the strategic and tactical risk-based approaches for selecting, qualifying, monitoring, and managing CMO’s and other critical suppliers. It includes a review of domestic and international regulatory requirements and operational aspects including the role of the Quality Management System. An in-depth discussion of Master Service Agreements, Quality Agreements, CMO risk assessment/mitigation, and current outsourcing issues will be presented.

In addition, the course examines how best practices of project management can transform an outsourcing schedule into a true project plan.

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


Apr 19, 2018


Education (Higher Ed)


Live / Seminar, Seminar



Credits / Hours

1.2 CEUs



Presenters / Authors / Faculty

Frank Carroll, Carroll Pharma Consulting, LLC, Pharmaceutical Operations/Supply Chain

Keywords / Search Terms

CfPA Outsourcing, Contract Manufacturing Organizations, CMO, Quality Management System, Regulatory, pharmaceutical industry, biological, device, diagnostics, cosmetics Seminar CE CME

LIVE Activity Location Details

04-17-2018 - 04-18-2018

New Brunswick
United States of America

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