Validation of Analytical Procedures - Made Easy
Errors in measurement can significantly add to safety risks and
business costs. With that in mind, this workshop helps participants
understand how to organize, conduct, evaluate AND improve their
measurement systems and procedures. There will be a particular focus on
evaluations made by laboratories and diagnostic medical devices.
Examples of industry best practices are provided.
approach provides the fundamentals of measurement system analysis. Goals
specific to analytical procedures are defined. Statistical and
graphical tools are presented to help evaluate and improve the
procedures. The content is based on the requirements and guidance of
the: FDA’s Quality System Regulation (21CFR820); FDA’s Current Good
Manufacturing Practices for Finished Pharmaceuticals (21CFR 211); ICH’s
Guideline on Validation of Analytical Procedures (Q2(R1)); and
ISO/AIAG’s Standard on Measurement System Analysis (MSA-4).
There are no prerequisites for this webinar. Given the presenter’s “keep-it-simple” approach to the material, no background in statistics is needed. Applications of popular statistical software programs are demonstrated. This is a natural follow-on webinar to the Test Method Validation (TMV) webinars offered previously. While knowledge of variable TMV would be helpful, it is not a prerequisite for this webinar.
Upon completion of the webinar, participants will understand how to:
- Organize validations of their test methods and analytical procedures
- Conduct these validations and collect data using appropriate methods
- Apply statistical tools and methods to analyze the results of their validations using metrics and graphical tools
- Apply metrics and graphical tools to improve their analytical procedures
Who Should Attend?
Virtual Training Information
Peter Knepell, PhD
President, Peak Quality Services
Certified Quality Engineer (CQE)
Certified Software Quality Engineer (CSQE)
AAMI faculty for: Process Validation, Statistical Tools & Methods, and Design of Experiments.