Unit III - Method Validation
(March 16 - April 5, 2026)

For each unit, you will need to do the following:

  1. Review Unit Activity Sheet

  2. View Presentations and Videos

  3. Complete Readings

  4. Complete Discussions on Google Groups

  5. Complete and E-mail homework (s)to outreach@otsc.tamu.edu.  Put Homework # _ in subject line.

Learning Objectives
Learn both the terminology and procedures for calculating performance indicators in laboratory method validation to assess fitness for purpose with an emphasis on instrumental methods; Understand the purpose of analytical procedure validation in a quality control laboratory with an emphasis on rapid methods

Unit III Activity Sheet
(Links to all presentations, readings, and activities for Unit III)

Assignments

  1. Google Groups Graded Discussion # 4: Due by Midnight on Monday, March 23, 2026(5 pts)
    Method validation is an essential component of the measures that a laboratory should implement to allow it to produce reliable analytical data. All methods selected for use in a laboratory needs to be validated prior to use. Explain the criteria that should be used to select methods in a laboratory. List the steps involved in validating a method including any statistical analysis that should be conducted. Use assigned readings as appropriate.
    Submit in course Google Group under Graded Discussion #4 Thread;
    Access google group @Laboratory Quality Systems – Spring 2026 - Google Groups
    E-mail: lqs_2026_spring@lists.tamu.edu

  2. Google GroupsGraded Discussion # 5 –Due by Midnight on Monday, April 6, 2026(5 pts)
    Reference Materials play a very important rule in method validation.  However, in some cases, reference materials are not readily available. In this case, how would you validate a method without a reference material?
    Submit in course Google Group under Graded Discussion #5 Thread;
    Access google group @Laboratory Quality Systems – Spring 2026 - Google Groups
    E-mail: lqs_2026_spring@lists.tamu.edu


  3. Homework # 5 (Calculations for Validation) – Due by Midnight on Monday, March 30, 2026(20 pts)
    E-mail homework to outreach@otsc.tamu.edu.  Put Homework# 5 in subject line.|
    1.     Data for Homework # 5