GMP Expectations for Products Used in Early Phase IND Studies - Webinar By GlobalCompliancePanel

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GMP Expectations for Products Used in Early Phase IND Studies - Webinar By GlobalCompliancePanel Powered By Docstoc
					                                                                                                                                            




            Date : Tuesday, November 16, 2010

            Time : 10:00 AM PDT | 01:00 PM EDT
                                                        Live Webinar
        Duration : 75 Minutes                           GMP Expectations for Products Used in
                                                        Early Phase IND Studies
           Price : $245.00


                                                                    
         Overview: FDA issued a guidance document covering GMP                                                                          
         requirements for Phase 1 products. These guidelines remove                          Register Now
         some of the problems that are encountered with early phase
         products and are in addition to those that cover the CMC                    Instructor Profile:
         sections for IND submissions at Phase 1. Although the
                                                                                             Steven S Kuwahara
         guidance appears to remove the need to follow GMPs for
                                                                                             Founder & Principal, GXP
         Phase 1 products, the need to follow GMPs is still present in                       Biotechnology, LLC
         the Food, Drug, and Cosmetic Act. Thus the nature and extent
                                                                                     Steven S. Kuwahara, Ph.D. is the
         of GMP-related activities will depend upon the nature of the
                                                                                     founder and Principal of GXP
         investigational drug and the extent of the study that is
                                                                                     BioTechnology LLC, a consulting firm
         planned. This presentation will review the GMP guidance
                                                                                     that works in the areas covered by
         document and discuss how it may be integrated with the
                                                                                     the GLP and GMP of drugs, biologics,
         recommendations of the guidance documents on CMC
                                                                                     and nutraceuticals. Steve has over             
         requirements.
                                                                                     30 years of experience in supervising
                                                                                     quality control laboratories, including
         Areas Covered in the Session:                                               an animal testing facility, and in
                                                                                     performing GLP and GMP audits of
           l    Discussion of the elements found in the guidance                     internal and external testing
                document for Phase 1 material.                                       laboratories . Steve has participated
           l    What to do at really early stages.                                   in the development of drugs and
           l    What about special IND studies?                                      biologicals through all phases of
           l    What about preclinical studies?                                      clinical research and final product
           l    Varying GMP activities that depend upon the nature of                production. ...more
                the IND product.
                                                                                                                                 
           l    What are the requirements for the GMP found in the
                Food, Drug, and Cosmetic Act?
                                                                                     Suggest a Topic       More Webinars

           l    What to do about QC activities such as instrument
                                                                                        Your Necessity is our Priority
                qualification, method validation, and process validation.
                                                                                                                                
         Click here to register for this webinar

         Who Will Benefit:

           l    Regulatory Affairs personnel who coordinate activities
                for the CMC sections of submissions.
           l    QA/QC personnel who need to plan work on early
                stage material
           l    R & D personnel who will contribute data to CMC
                sections.
           l    Project managers for product development studies.
           l    Quality systems auditors
           l    Consultants

         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
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         1200 Wilmington DE 19801

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DOCUMENT INFO
Description: FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1. Although the guidance appears to remove the need to follow GMPs for Phase 1 products, the need to follow GMPs is still present in the Food, Drug, and Cosmetic Act. Thus the nature and extent of GMP-related activities will depend upon the nature of the investigational drug and the extent of the study that is planned. This presentation will review the GMP guidance document and discuss how it may be integrated with the recommendations of the guidance documents on CMC requirements. Areas Covered in the Session: l Discussion of the elements found in the guidance document for Phase 1 material. l What to do at really early stages. l What about special IND studies? l What about preclinical studies? l Varying GMP activities that depend upon the nature of the IND product. l What are the requirements for the GMP found in the Food, Drug, and Cosmetic Act? l What to do about QC activities such as instrument qualification, method validation, and process validation. Click here to register for this webinar Who Will Benefit: l Regulatory Affairs personnel who coordinate activities for the CMC sections of submissions. l QA/QC personnel who need to plan work on early stage material l R & D personnel who will contribute data to CMC sections. l Project managers for product development studies. l Quality systems auditors l Consultants