Suppose you have a complex piece of laboratory equipment or you are manufacturing a diagnostic medical device. A critical question is: “How do you know that you can trust measurements from those instruments?” This webinar will provide a working knowledge of Validation of Analytical Procedures. This very valuable statistical methodology is essential for laboratories and certain diagnostic medical devices.
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.
The 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 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. 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:
Instruction is targeted to professionals concerned with: research and development, new product development, process development, manufacturing engineering, quality engineering, quality assurance, quality control, line operations, measurement lab operations, and regulatory compliance. There are no prerequisites.
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