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

Training Options

  •   Duration: 75 Minutes  
  • Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
    Price: $295.00
  • Refund Policy

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.

Reference material for easy implementation:
  • SOP: Validation of Analytical Methods
  • Checklist: Validation of Analytical Methods
  • 65-page Primer: Validation of Analytical Methods
Areas Covered in the Session:
  • 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
Who Will Benefit:
  • 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
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.


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