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Qualification and Management of CMO’s

  January 03, 2018  
CfPA-The Center for Professional Advancement, New Brunswick, NJ
April 17-18, 2018

Who Should Attend?
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 Contract Manufacturing Organizations

Course Description
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.
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
   Frank Carroll, Carroll Pharma Consulting, LLC, Pharmaceutical Operations/Supply Chain

Frank Carroll is currently an independent pharmaceutical operations/supply chain consultant and Principal of Carroll Pharma Consulting, LLC. He has over 25 years’ experience in the Pharmaceutical, Device, Biologics, and Biotech industries in many aspects of operations including commercial and clinical product manufacturing and supply chain; purchasing; strategic alliance management; implementation of advanced project management systems; MRP/ERP systems; and senior operations management. He has held senior consulting positions at Pharmatech Associates and senior management positions at Zosano Pharma, Genitope Corp., Alpha Therapeutics, McGhan/Inamed Corp., Collagen Corp., and Bayer AG.

He has earned certifications from APICS (CPIM), ASQ (CQE), and Zenger-Miller as a certified trainer. He has instructed/directed numerous courses for the Center for Professional Advancement, instructed courses for APICS CPIM certification, and was a faculty member at Indiana University at South Bend in Continuing Education programs. He received his B.Sc. degree from The Ohio State University and MBA and MSBA degrees from Indiana University at South Bend.


Deadline for Abstracts: n/a
Registration: Please click here for registration information.
E-mail: jmorbit@cfpa.com
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