Presented by Elzabé Truter
PURPOSE / OBJECTIVES
Method validation is the process that provides evidence that a given analytical method, when correctly applied, produces results that are fit for purpose. No matter how well a method performs elsewhere, analysts / technicians need to confirm that the method is valid when applied in their laboratory.
This course will give detailed information and hands-on experience of practical issues of quality control and the requirements for accreditation. The course presenter will share experiences and provide practical examples on how to establish quality assurance / control procedures and how to validate methods in preparation for accreditation or maintenance of accreditation to the ISO/IEC 17025:2017 standard. Most importantly, this course will equip delegates with the knowledge and skills to draw up method validation documents suitable for ISO/IEC 17025:2017 accreditation. It will also provide laboratories with the opportunity to determine whether their work is performed correctly and according to appropriate standards and to understand the critical areas of method validation and how to apply uncertainty of measurement in microbiology.
The course will run over a period of three (3) days.
After the training course, participants should be able to:
1. Understand the approach of method validation and uncertainty of measurement in Microbiological methods.
2. Select test methods and develop method validation protocols and experimental design.
3. Set performance criteria for different parameters based on test methods (qualitative and quantitative).
4. Use of Proficiency Testing data in method validation.
5. Statistically evaluate data.
6. Document validation results and generate validation reports.
7. Perform on-going verification of test methods to ensure / demonstrate fitness for purpose.
8. Understand the requirements for method validation and uncertainty of measurement by accreditation bodies.