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Validation of Analytical Methods for FDA Compliance: Step-by-Step

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    Live Webinar         on
 
     Validation of Analytical Methods for FDA Compliance: Step-by-Step

                                                                                                                                   
     Course "Validation of Analytical Methods for FDA Compliance:
     Step-by-Step" has been pre-approved by RAPS as eligible for
     up to 1.25 credits towards a participant's RAC recertification
                                                                                                Register Now                       

     upon full completion.


    Date & Time:                                                                           Instructor Profile:

     Thursday, May 24, 2012             10:00 AM PDT | 01:00 PM EDT
                                                                                                      Dr. Ludwig Huber
     Duration: 75 Minutes               Instructor: Dr. Ludwig Huber                               Chief Advisor - Global FDA
                                                                                                      compliance, Agilent
     Location: Online                   Price : $245.00   (for one participant)                           Technologies


                                                                                           Ludwig Huber, Ph.D., is Director of
    Overview:                                                                              Labcompliance and Chief Advisor for
    Analytical methods should be validated to ensure reliability,                          global FDA compliance at Agilent
    consistency and accuracy of analytical data. Method validation has                     Technologies. He is the editor of
    been a requirement of FDA and international regulations and                            Labcompliance, the global on-line
                                                                                           resource for validation and
    accreditation standards such as ISO 17025 since many years. Most
                                                                                           compliance issues for laboratories.
    often the theory is well understood but there are many questions
                                                                                           He is the author of the books
    when validation experiments are designed, conducted, and                               "Validation and Qualification in
    documented.                                                                            Analytical Laboratories, and
                                                                                           "Validation of Computerized
    This webinar will provide a good understanding on how to effectively                   Analytical and Networked Systems",
    prepare, conducts and document method validation experiments for                       Informa Healthcare. ...more
    FDA and ISO 17025 compliance.


    Reference material for easy implementation:                                           Suggest a Topic       More Webinars

                                                                                            Your Necessity is our Priority
       l   SOP: Validation of Analytical Methods
       l   Checklist: Validation of Analytical Methods
       l   65-page Primer: Validation of Analytical Methods

                                                                                   
    Areas Covered in the Session:                                                                            


       l   FDA regulations and guidelines
       l   Examples of warning letters and how to avoid them
       l   USP Chapters and ICH Guides
       l   Developing an SOP for method validation
       l   Development of a validation plan for success
       l   Prerequisites for method validation
       l   Defining the minimum number of validation experiments that
           satisfy ICH, FDA and USP
       l   Defining test conditions and acceptance limits
       l   Verification of compendial methods according to USP <1226>
       l   To revalidate or not after method changes
       l   Transferring a method to routine according to USP <1224>
       l   Seven most common method validation pitfalls and how to
           avoid them
       l   Using software for automated method validation
       l   Documentation for the FDA and for other agencies


    Click here to register for this webinar


    Who Will Benefit:


       l   Laboratory managers and supervisors
       l   GLP/GCP/GMP auditors
       l   ISO 17025 auditors
       l   QA/QC managers and personnel
       l   Analysts and other laboratory staff
       l   Regulatory affairs
       l   Training departments
       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



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DOCUMENT INFO
Description: Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented.