Skip to main content

Validation of Analytical Procedures - Made Easy

Upcoming Virtual Courses

Overview

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 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. 

Objectives

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?

Instruction is targeted to industry and FDA 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.

Virtual Training Information

Our virtual training environment allows you to have direct interaction with your instructors and your fellow attendees. AAMI uses Zoom for virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.
For virtual training courses, we request that you register at least one week in advance of the course start date to allow sufficient time for shipping of training materials and devices (Please allow two weeks for non-U.S. addresses). If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course but you will have access to digital versions of the materials. If you have any questions, please email education@aami.org.