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Qualification and Management of Contract Manufacturing Organizations (CMOs)

  November 14, 2019  
CfPA-The Center for Professional Advancement, Amsterdam, The Netherlands
9-10 March 2020

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 CMO’s, Contract Development & Manufacturing Organizations  (CDMO’s), and Contract Research Organizations (CRO’s) 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 Description
Every pharmaceutical company hopes to obtain their 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 intensive 2-day accredited 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, 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 Director of Supply Chain and Facilities for Zosano Pharma/ZP Group LLC in Fremont CA. He has over 25 years of experience in the Pharmaceutical, Device, Biologics and Biotech industries in many aspects of operations including manufacturing, purchasing, materials management, strategic alliance management, implementation of advanced project management and MRP/ERP systems and senior operations management. He has held senior management positions with Genitope Corp., Alpha Therapeutics, 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. from The Ohio State University and MBA and MSBA degrees from Indiana University.
Deadline for Abstracts: N/A
Registration: Please click here for registration information.
E-mail: Jmorbit@cfpa.com
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