Validation of Analytical Methods for FDA Compliance: Step-by-Step - Webinar By GlobalCompliancePanel 2012

  • 24 May 2012
  • Webinar

Description

Validation of Analytical Methods for FDA Compliance: Step-by-Step is a webinar that covers topics such as:

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

Validation of Analytical Methods for FDA Compliance: Step-by-Step brings together GLP/GCP/GMP auditors, Laboratory managers and supervisors, QA/QC managers and personnel, ISO 17025 auditors, Regulatory affairs, Analysts and other laboratory staff, Consultants and Training departments.

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Important

Please, check "Validation of Analytical Methods for FDA Compliance: Step-by-Step - Webinar By GlobalCompliancePanel" official website for possible changes, before making any traveling arrangements

Event Categories

Health & Medicine: Healthcare, Hospitals & Clinics, Medical device, Medical laboratories, Pharma

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