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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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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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