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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

 

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upon full completion.

Date & Time:

Instructor Profile:

Thursday, May 24, 2012

10:00 AM PDT | 01:00 PM EDT

Duration: 75 Minutes

Instructor: Dr. Ludwig Huber

Location: Online

Price : $245.00

Dr. Ludwig Huber Chief Advisor - Global FDA compliance, Agilent Technologies

(for one participant)

Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of Labcompliance, the global on-line resource for validation and compliance issues for laboratories. He is the author of the books "Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare. ...more

Overview: 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. This webinar will provide a good understanding on how to effectively prepare, conducts and document method validation experiments for FDA and ISO 17025 compliance.

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Your Necessity is our Priority l l l

SOP: Validation of Analytical Methods Checklist: Validation of Analytical Methods 65-page Primer: Validation of Analytical Methods

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

Click here to register for this webinar Who Will Benefit: l l l l l l l l

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

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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 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe

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

Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requ...

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