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CfPA-The Center for Professional Advancement, New Brunswick, NJ
October 11-12, 2017
Who Should Attend? This course has been designed for those who need to implement, improve, and/or manage outsourced operations in the pharmaceutical industry as well as the biological, device, diagnostics and cosmetics industries. It will be of particular interest to individuals in:
• Corporate & Plant Management • Purchasing: Materials Management/Project Management • Manufacturing • Packaging • Engineering • Process Development • Regulatory Affairs • QA/QC • Management of Contract Manufacturing Organizations
RAPS - Regulatory Affairs Professional Society This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's recertification of their Regulatory Affairs Certification (RAC) upon full completion. Course Description
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Organized by:
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CfPA-The Center for Professional Advancement |
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Invited Speakers:
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Course Director | | Frank Carroll; Director, Supply Chain and Facilities, Zosano Pharma/ZP Group LLC |
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.
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Deadline for Abstracts:
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N/A
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Registration:
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Please click here for registration information.
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E-mail:
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Jmorbit@cfpa.com
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This practical course outlines both 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.