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CfPA-The Center for Professional Advancement, 90 Minute Accredited Online Training
March 19, 2015 at 11:00 a.m.–12:30 p.m. (ET)
Who Should Attend?
This online training course should benefit those who need to know how to design, organize, and implement the change control process as part of an effective quality system. It is suitable for relevant personnel in QA, QC, Regulatory Affairs, Manufacturing, and Corporate Management. It is applicable to professionals who work in the pharmaceutical and biopharmaceutical industries. 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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| Luke T. Foo, Sr. Director of Quality Assurance, Celsion Corporation. |
Luke T. Foo, is currently Sr. Director of Quality Assurance at Celsion Corporation. He has over 20 years of senior management experience in QA/QC, in which he has developed quality systems at various organizations including Pfizer, Watson Labs, and Spectrum Pharmaceuticals. He started his career in Manufacturing, progressed to Product Development, and then transitioned to Quality Assurance/Quality Control. He is a senior member of American Society of Quality (ASQ), Parenteral Drug Association (PDA), and Mid-Atlantic Region Society of Quality Assurance (MARSQA). He recently became ASQ certified as a Certified GMP Professional. He has a B.S. in Pharmacy from the Brooklyn College of Pharmacy and an M.S. in Management Systems Analysis from Kean 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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sberg@cfpa.com
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FDA, EMA, and other international regulatory agencies require that there be an adequate change control system as a subsystem of a company’s overall quality system.
This 90-minute accredited training will explain the regulatory basis for change controls, the steps in designing a change control system, and the types of documents or processes that are subject to change control. During the course we will walk through the steps in executing a change control form by using a case study.