Introduction to Method Validation (EMU 400W)

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.

This virtual instructor-led course will be conducted online. On the right side of the page you will see the dates and times available for this course, each with an individual registration link. Learners will attend using a virtual learning program called Adobe Connect, and will participate in live discussion and activities. A webcam and microphone are required. Details about how to log into Adobe Connect will be provided after your registration is complete.

Prerequisites

Participants should be proficient in spreadsheet use and understand the requirements for method validation and verification of ISO/IEC 17025:2017.

Target Attendees

Target learners include Laboratory Managers, Engineers, Scientists, or Technicians.

Learning Outcomes

After successful completion of the course, participants will be able to:

1. Discuss the history of method calidation from USP, FDA, and GxP perspectives;
2. Describe the concepts and differences between quality control and quality assurance;
3. Define terms such as accuracy, precision, specificity, ruggedness, detection limits, etc.
4. Given data, determine repeatability, reproducibility, and ruggedness;
5. From memory, outline the required contents for documenting and validating a method; and
6. Using a validation template, choose a method type and perform a mock validation

LEUs Awarded

0.7 LEUs Awarded

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