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Understanding and Preparing for FDA's New Part 11 Inspection Program - Webinar By GlobalCompliancePanel

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Understanding and Preparing for FDA's New Part 11 Inspection Program - Webinar By GlobalCompliancePanel Powered By Docstoc
					                                                                                                                                   


    Live Webinar           on

        Understanding and Preparing for FDA's New Part 11 Inspection
        Program

    Date & Time:                                                                                                                    

        Tuesday, January 25, 2011        10:00 AM PST | 01:00 PM EST
                                                                                                 Register Now                          
        Duration: 75 Minutes             Instructor: Dr. Ludwig Huber

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

                                                                                            Instructor Profile:

        Overview:
                                                                                                       Dr. Ludwig Huber
    Within the next few weeks and months the FDA will conduct a series                              Chief Advisor - Global FDA
    of Part 11 related inspections.                                                                    compliance, Agilent
                                                                                                           Technologies
    Planned routine inspections will be extended to evaluate the
    companies' practices to ensure accuracy, integrity, authenticity and                    Ludwig Huber, Ph.D., is Director of
    availability of electronic records, and the FDA plans additional 'for                   Labcompliance and Chief Advisor for
    cause inspections'. Inspections are planned for US but also in foreign                  global FDA compliance at Agilent
                                                                                            Technologies. He is the editor of
    countries. The program is the long awaited next step for Part 11 and
                                                                                            Labcompliance, the global on-line
    nevertheless it came as a surprise to the industry.
                                                                                            resource for validation and
                                                                                            compliance issues for laboratories.
        Reference material for easy implementation:                                         He is the author of the books
                                                                                            "Validation and Qualification in
    l    25 recent FDA Warning Letters with part 11 violations.                             Analytical Laboratories, and
    l    15 Case Studies: Implementing Part 11                                              "Validation of Computerized
    l    Validation templates and examples                                                  Analytical and Networked Systems",
                                                                                            Informa Healthcare. ...more

        Areas Covered in the Session:
    l    FDA inspections: Preparation, conducts, follow up
                                                                                           Suggest a Topic       More Webinars
    l    Learning from past Part 11 inspections
                                                                                             Your Necessity is our Priority
    l    Scope of the new Part 11 program: time frame, expected outcome
    l    Criteria for selection of target companies
    l    What inspectors are looking for
    l    How to prepare your company for the upcoming inspections
    l    Learning from previous inspections with focus on Part 11 and
         computer validation: most frequently cited deviations                                                
    l    How to fill gaps short term
    l    Developing a program for long term
    l    Creating the right documentation to satisfy the inspectors
    l    Most likely next steps after the inspection program


    Click here to register for this webinar


        Who Will Benefit:

    l    IT managers and system administrators
    l    QA managers and personnel
    l    QC and Lab managers
    l    Validation specialists
    l    Regulatory affairs
    l    Training departments
    l    Documentation department
    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 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.


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www.globalcompliancepanel.com
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1200 Wilmington DE 19801

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


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DOCUMENT INFO
Description: Overview: Within the next few weeks and months the FDA will conduct a series of Part 11 related inspections. Planned routine inspections will be extended to evaluate the companies' practices to ensure accuracy, integrity, authenticity and availability of electronic records, and the FDA plans additional 'for cause inspections'. Inspections are planned for US but also in foreign countries. The program is the long awaited next step for Part 11 and nevertheless it came as a surprise to the industry. Reference material for easy implementation: * 25 recent FDA Warning Letters with part 11 violations. * 15 Case Studies: Implementing Part 11 * Validation templates and examples Areas Covered in the Session: * FDA inspections: Preparation, conducts, follow up * Learning from past Part 11 inspections * Scope of the new Part 11 program: time frame, expected outcome * Criteria for selection of target companies * What inspectors are looking for * How to prepare your company for the upcoming inspections * Learning from previous inspections with focus on Part 11 and computer validation: most frequently cited deviations * How to fill gaps short term * Developing a program for long term * Creating the right documentation to satisfy the inspectors * Most likely next steps after the inspection program Click here to register for this webinar Who Will Benefit: * IT managers and system administrators * QA managers and personnel * QC and Lab managers * Validation specialists * Regulatory affairs * Training departments * Documentation department * Consultants