Introduction to Method Validation
Participants will learn the history of method validation, understand conceptual differences in topics such as quality conceptual differences in topics such as quality control/quality assurance, and method validation/method verification. In-depth discussions will focus on the elements that appropriately validate an analytical method with respect to method type and provide participants with a template for the method validation process.
Participants should be proficient in spreadsheet use and understand the requirements for method validation and verification of ISO/IEC 17025:2017.
The participant will need to bring a laptop computer (PC or MAC) with Microsoft Excel or similar spreadsheet installed. Please note that the tablet and smart phone versions of Excel and other spreadsheets do not have the full functionality of the PC versions and the participant may not be able to utilize all the power of the spreadsheet covered during the training.
Target learners include Laboratory Managers, Engineers, Scientists, or Technicians.
After successful completion of the course, participants will be able to:
- Discuss the history of method calidation from USP, FDA, and GxP perspectives;
- Describe the concepts and differences between quality control and quality assurance;
- Define terms such as accuracy, precision, specificity, ruggedness, detection limits, etc.
- Given data, determine repeatability, reproducibility, and ruggedness;
- From memory, outline the required contents for documenting and validating a method; and
- Using a validation template, choose a method type and perform a mock validation
0.7 LEUs Awarded*