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A Comparison of ICH Q-10 Quality System and the FDA's Quality Systems Approach (QSA) to the Pharmaceutical GMPs - Webinar By GlobalCompliancePanel

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A Comparison of ICH Q-10 Quality System and the FDA's Quality Systems Approach (QSA) to the Pharmaceutical GMPs - Webinar By GlobalCompliancePanel Powered By Docstoc
					                                                                                                                                  


    Live Webinar           on

        A Comparison of ICH Q-10 Quality System and the FDA's Quality
        Systems Approach (QSA) to the Pharmaceutical GMPs

    Date & Time:                                                                                                                   

        Tuesday, January 11, 2011        10:00 AM PST | 01:00 PM EST
                                                                                              Register Now                            
        Duration: 90 Minutes             Instructor: Howard Cooper

        Location: Online                 Price : $245.00   (for one participant)

                                                                                        Instructor Profile:

        Overview:
                                                                                                     Howard Cooper
    In September of 2006, the FDA published the Quality System                                    President, EQACT, Inc.
    Approach to Pharmaceutical Good Manufacturing Practices which
    provided a quality orientation to the GMP's.
                                                                                        Howard enjoys sharing his 30 years
                                                                                        plus experience in starting up,
    Then in June of 2008, The International Conference on
                                                                                        developing, implementing,
    Harmonization (ICH) published ICH-Q10, Pharmaceutical Quality                       managing, and remediating
    System. These guidance documents have provoked thought and                          pharmaceutical and medical device
    raised questions about existing pharmaceutical.                                     quality systems. He has a BS in
                                                                                        Biology/Chemistry and Political
                                                                                        Science as well as work toward an
        Areas Covered in the Session:                                                   MBA. His ability to quickly learn the
                                                                                        technology is demonstrated by his
    l    What are the objectives of ICH-Q10 and the FDA's Quality
                                                                                        success in applying quality
         Systems Approach to Pharmaceutical Good Manufacturing
                                                                                        assurance principles to a wide range
         Practices?                                                                     of pharmaceuticals and medical
    l    What are the similarities and differences between these guidance               devices. He is a Certified Biomedical
         documents?                                                                     Auditor (CBA), Certified Quality
    l    What are some Pro and Cons of the product lifecycle for                        Manager (CQM), and Quality Auditor
         pharmaceuticals                                                                (CQA). His technical education is
    l    Is the Quality Systems Approach really "Compliance in Sheep's                  further complemented by his Political
                                                                                        Science degree helping him
         Clothing?
                                                                                        understand the regulatory process;
    l    Who will win the GMP battle-Quality or Compliance
                                                                                        his work toward an MBA provides
                                                                                        business insight. He is a member of
    Click here to register for this webinar                                             ASQ, PDA, AAMI, RAPS, and SQA.
                                                                                        He strongly believes that Quality is
                                                                                        very influential in shaping successful
        Who Will Benefit:
                                                                                        operations. ...more
    l    Quality Unit Supervisors/Managers/Directors
    l    Manufacturing Supervisors/Managers/Directors
    l    Support Functions to Quality or Manufacturing                                 Suggest a Topic       More Webinars
    l    Regulatory Affairs personnel responsible for GMP Compliance and
         filings                                                                         Your Necessity is our Priority
    l    Support personnel responsible for GMP Related activities such as
         Calibration and Testing Functions
    l    Validation personnel
    l    R&D Professional, Supervision and Management
                                                                                                          
     

It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely
benefit from this program.

For more information, please contact the event coordinator. We look forward to seeing you at the webinar.

Best regards,
Event-coordinator
GlobalCompliancePanel



About GlobalCompliancePanel
GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online
compliance training by creating a single window of learning opportunities for compliance professionals & providing a
forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our
commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training
sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions,
giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs.
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and development on/through our website. Keep track of all webinars arranged for your industry through notifications &
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DOCUMENT INFO
Description: Overview: In September of 2006, the FDA published the Quality System Approach to Pharmaceutical Good Manufacturing Practices which provided a quality orientation to the GMP's. Then in June of 2008, The International Conference on Harmonization (ICH) published ICH-Q10, Pharmaceutical Quality System. These guidance documents have provoked thought and raised questions about existing pharmaceutical. Areas Covered in the Session: * What are the objectives of ICH-Q10 and the FDA's Quality Systems Approach to Pharmaceutical Good Manufacturing Practices? * What are the similarities and differences between these guidance documents? * What are some Pro and Cons of the product lifecycle for pharmaceuticals * Is the Quality Systems Approach really "Compliance in Sheep's Clothing? * Who will win the GMP battle-Quality or Compliance Click here to register for this webinar Who Will Benefit: * Quality Unit Supervisors/Managers/Directors * Manufacturing Supervisors/Managers/Directors * Support Functions to Quality or Manufacturing * Regulatory Affairs personnel responsible for GMP Compliance and filings * Support personnel responsible for GMP Related activities such as Calibration and Testing Functions * Validation personnel * R&D Professional, Supervision and Management