Validation of Analytical Methods and Procedures

Dr. Ludwig Huber
Instructor:
Dr. Ludwig Huber
Duration:
60 Minutes
Product Id:
501090
Access:
6 months

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Price Details
$190 Recorded
$390 Corporate Recorded
Price Detail Options
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
  • Requirements of ISO 17025
  • Developing an SOP for method validation
  • Development of a validation plan
  • Defining parameters and acceptance limits
  • Validation of standard and compendial methods
  • When to revalidate after method changes
  • Transferring a method to routine
  • Using software for automated method validation
  • Documentation for the FDA, other agencies and for ISO 17025

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


Speaker Profile
Dr. Ludwig Huber Ph.D., is the director and editor of Labcompliance the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems, Informa Healthcare". He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. For more information, please visit Dr. Huber's website www.ludwig-huber.com


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