Validation and Metrology

This module will provide the student with knowledge of validation and an introduction to metrology as applied in industry. The student will understand the difference between validation and calibration and the importance of each in an industry setting.

1. Interpret the various regulations, guidelines and standards for Validation and Calibration and understand their importance within GMP (Good Manufacturing Practice).

2. Examine the major steps involved in Validation of manufacturing operations, including processes, equipment and automated / computerized systems.

3. Explain the science behind Metrology and the importance of measurement traceability and Calibration within a Quality System.

4. Describe the role of Computerised Systems and smart instruments, the data they create in the laboratory and how Computerised System Validation (CSV) is carried out

5. Evaluate laboratory data use, storage and failure handling practices to ensure data integrity in laboratory Computerised Systems and instruments.

6. Develop an outline approach to an analytical method validation with reference to the ICH Q2 guidance.