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Deviation System Requirements in the Life Science Industry

  February 11, 2015  
CfPA-The Center for Professional Advancement, 90 Minute Accredited Online Training
March 19, 2015 at 1:30 p.m.–3:00 p.m. (ET)

Who Should Attend?
This course will be beneficial to those who need to know how to design, organize, and implement the Deviation 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, biopharmaceutical, and medical device industries.

Course Description
This course will be available On Demand: March 20, 2015

FDA, EMA, and other international regulatory agencies require that there be an adequate Deviation and associated CAPA system as a subsystem of a company’s overall quality system.

This 90-minute accredited training course will explain the regulatory basis for a deviation system, the steps in designing a deviation system, and related topics such as planned and unplanned deviations, discrepancies, investigations, root cause analysis, and CAPA. During the course we will walk through the steps in executing a deviation report form by using a case study.

To maximize your learning experience, our course director recommends 
that participants attend this training’s companion course:

Change Control Essentials
Course ID #2658
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
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.
Deadline for Abstracts: n/a
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
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