AAMI Presents: Understanding Valid Statistical Techniques for Process Validation (Virtual)

October 20 - October 22, 2021
1:00-3:00 PM

To Register: Valid Statistical Techniques for Process Validation | AAMIOverview (force.com)

Registration  Fees: 

$499 (non-member) / $449 (member)

About the Series

When preparing a new medical device for market, the manufacturing process and product quality must be verified. A big challenge for process validation is to establish objective evidence that a process is capable of consistently delivering a quality product. This 2-part webinar series will demonstrate how valid statistical techniques can overcome this challenge – and better yet, save time and resources without complex statistics. 

While most webinars cover the “What and Why” for a subject, these webinars will also give ideas on the “How To” for valid statistical techniques. This “How To” will cover actual examples of application and discuss methods for writing protocols and reports. The discussion of documentation is especially important for FDA-regulated companies. You will hear directly from an industry expert on this important topic and you can ask questions and get answers. The presenter has over 25 years of experience helping a broad variety of firms apply statistical tools and techniques.

The application of valid statistical techniques is encouraged by the FDA’s Quality System Regulation, the FDA’s cGMP for Finished Pharmaceuticals, and ISO Standard 13485 for Medical Devices. The content reinforces the topics covered in the Process Validation Guidance document endorsed by the Global Harmonization Task Force (GHTF). Emphasis will be placed on best practices for quality systems in industry.




Meet the Faculty

Stephen Grimes

Pete Knepell


Program Objectives

FDA and AAMI faculty work together to help the learner to:

  • Explore valid statistical techniques for Process Validation
  • Provide a mapping of tools and techniques to IQ, OQ and PQ activities
  • Provide examples of industry best practices in each area
  • Discuss options for documentation
  • Demonstrate how these tools support regulatory compliance, especially if mandatory or voluntary action is required


Day 1: October 20, 2021 | 1:00-3:00PM ET

  • Setting the Stage for FDA-requirements and expectations
  • Test Method Validation for IQ
  • Exploring Historical Data for OQ & PQ
  • Process Capability Measures for OQ & PQ
  • Question and Answer Period

Day 2: October 22, 2021 | 1:00-3:00PM ET

  • Applying Design of Experiments for OQ
  • Sampling Plans for PQ
  • Process Control Charts for PQ and Process Monitoring
  • Question and Answer Period

Who Should Attend?

This material will appeal to quality professionals and managers in industry and regulatory agencies. Instruction is targeted to: quality engineers, process & manufacturing engineers, regulatory compliance professionals, and members of the leadership team.

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