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Preparing for and Surviving an FDA Inspection - Webinar By GlobalCompliancePanel

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Preparing for and Surviving an FDA Inspection - Webinar By GlobalCompliancePanel Powered By Docstoc
					                                                                                                                                            



            Date : Thursday, December 09, 2010

            Time : 10:00 AM PST | 01:00 PM EST
                                                        Live Webinar
        Duration : 60 Minutes                           Preparing for and Surviving an FDA
                                                        Inspection
           Price : $245.00


                                                                    
         Why you should attend:
                                                                                             Register Now                               
             l Recognize the purpose of the inspection
             l Learn how to properly communicate with the inspector                  Instructor Profile:
             l Anticipate what information the investigator can and
                                                                                              Kerry Paul Potter
               will request                                                                   President, Summit
             l Know how to keep the inspection from being an                                  Consulting, Inc.
               "emotional" event.                                                    Kerry gained his pharmaceutical
             l Know what is expected of you and your company                         manufacturing experience during his
             l Learn what not to say or do during an inspection.                     28-year career with Merck. His career
             l Recognize your audit responsibilities and vulnerabilities             spanned the areas of Quality
             l Identify the internal support system of a successful                  Operations, Audits & Inspections,
               inspection                                                            Laboratory, Human Resources, and
             l Realize what steps you/your company should take to                    Learning & Development. More
               prepare for a successful inspection                                   specifically, his responsibilities
                                                                                                                                    
                                                                                     included quality management of
         Areas Covered in the Session:                                               laboratory assessment, site GMP
                                                                                     lead auditor, FDA QSIT/Quality
             l   Expectations of an audit                                            Management System manager, 5S
             l   Why the FDA conducts inspections                                    coordinator, GMP trainer (annual,
             l   Pre-planning and preparation activities                             ongoing, new hire), OSHA
             l   What to do when the investigator arrives                            regulations and Process Safety
             l   What documents to have ready and on hand                            Management training, as well as
             l   Assignments and responsibilities for the inspection                 internal and external public relations.
             l   A review of Inspection Do's and Don'ts                              ...more
             l   The Opening and Close-out Sessions
             l   Actions to take after the inspection is over
                                                                                                                                 
                                                                                     Suggest a Topic       More Webinars

         Click here to register for this webinar                                        Your Necessity is our Priority

         Who Will Benefit:                                                                                                      
           l     Site Quality Operations Managers
           l     Quality Assurance personnel
           l     Plant Managers
           l     Manufacturing Superintendents and Managers
           l     Individuals whose job knowledge and/or expertise may
                 be required during an audit (Subject Matter Experts)

         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. GlobalCompliancePanel portal ensures a secure & cost effective online
         environment and also support your E-learning and development on/through our website. Keep track of all webinars
         arranged for your industry through notifications & event calendars being mailed to your inbox.
         GlobalCompliancePanel opens new doors of learning opportunities for professionals.


         GlobalCompliancePanel
         www.globalcompliancepanel.com
         1000 N West Street Suite,
         1200 Wilmington DE 19801

         Phone: 800-447-9407 or
         Fax your PO to: 302-288-6884


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DOCUMENT INFO
Description: Why you should attend: * Recognize the purpose of the inspection * Learn how to properly communicate with the inspector * Anticipate what information the investigator can and will request * Know how to keep the inspection from being an "emotional" event. * Know what is expected of you and your company * Learn what not to say or do during an inspection. * Recognize your audit responsibilities and vulnerabilities * Identify the internal support system of a successful inspection * Realize what steps you/your company should take to prepare for a successful inspection Areas Covered in the Session: * Expectations of an audit * Why the FDA conducts inspections * Pre-planning and preparation activities * What to do when the investigator arrives * What documents to have ready and on hand * Assignments and responsibilities for the inspection * A review of Inspection Do's and Don'ts * The Opening and Close-out Sessions * Actions to take after the inspection is over Click here to register for this webinar Who Will Benefit: * Site Quality Operations Managers * Quality Assurance personnel * Plant Managers * Manufacturing Superintendents and Managers * Individuals whose job knowledge and/or expertise may be required during an audit (Subject Matter Experts)