NEW – Method Validation (EMU 400)
Participants will learn the history of method validation, understand conceptual differences to topics such as quality control/quality assurance, and method validation/method verification. In-depth discussion about the elements of how to appropriately validate an analytical method with respect to method type will provide participants with template for method validation process and report.
1. (EMU 200) Intermediate Statistics
2. (EMU 201 or EMU 202) Applied Measurement Uncertainty
3. (EMU 250) Implementation of QA/QC Program and Risk Management Strategies Using Control Charts [Suggested]
4. Proficiency in Microsoft Excel spreadsheet use
The participant will need to bring a laptop computer with Microsoft Excel or similar spreadsheet installed.
After successful completion of the course, participants will be able to:
1. Discuss the history of method validation 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 and detection limits, etc.
4. Given data, determine repeatability, reproducibility and ruggedness
5. Identify and describe the different Method Validations by type
6. From memory, outline the required contents for documenting and validating a method
7. Using a validation template, choose a method type and perform a mock validation
0.8 CEUs Awarded*
*American Association for Laboratory Accreditation (A2LA) is accredited by the International Association for Continuing Education and Training (IACET) and is authorized to issue the IACET CEU.
October 4, 2018
5202 Presidents Ct.
Frederick, MD 21703
8:00 AM – 4:30 PM
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