Validation of laboratory methods

Validation of laboratory methods

A woman analyzing a sample in a laboratory

Learn to validate and verify analytical methods in laboratories in line with ISO/IEC 17025:2017, and ensure reliable and usable results.

A woman analyzing a sample in a laboratory

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Validation of laboratory methods

This course will give you an introduction to what validation and verification of analytical methods are, and what is normally required in terms of planning, implementation and documentation for these processes. The course will highlight the important elements of the validation based on ISO/IEC 17025:2017 with practical examples.

Requirements for validation and verification of analytical methods are becoming increasingly important for laboratories, as requirements from customers and authorities are developed and tightened. The laboratory must be able to demonstrate that the chosen methods produce valid and reproducible results, which are applicable to the customer and/or end user. Validation and/or verification will be able to prove that the results are reliable.

What you will learn in the course

  • What is verification and validation? And when to do what?
  • Documentation requirements
  • Verification/validation planning
  • Implementation of verification/validation (content, experimental studies, statistical design)
  • Reporting and conclusion
  • Qualitative vs Quantitative Methods
  • Practical examples

The course is based on lectures with the opportunity for questions and discussions along the way. Minor group work may occur during the day.

 

Program

Registration of participants
Presentation of the speaker and review of the course program
Voting and verification – what is what, and how to choose?
Coffee break
Requirements for validation and verification – planning, implementation and reporting
Lunch
Requirements for validation and verification – continued
Coffee break
Quantitative vs qualitative methods
Reporting requirements
Summary

Practical information

  • The course day lasts from 09:00 to 17:00, with registration of participants from 08:30. The course will be held physically, in central Oslo. The address will be sent out in advance.
  • If you cancel one of our professional courses or conferences after the registration deadline, a fee of 20 percent of the course or conference price will be charged. In case of cancellation later than three working days before the event, or in case of no-show, the full course fee will be invoiced. To cancel a course, send an e-mail to 

Hilde Ulvatne Marthinsen

The course instructor, Hilde Ulvatne Marthinsen, is a bioengineer with a master's degree in medical biochemistry and a doctorate in medical microbiology. Hilde has extensive experience from laboratory work and method development both in medical and in trial laboratories. She has served as a technical and lead assessor for Norwegian Accreditation and Swedac for a number of years, and has extensive experience in interpreting relevant standards in quality assurance.

Do you have any questions?