Quality by Design for Medical Device Engineers

Free Webinar

This webinar provides an in-depth review of the key statistical techniques that medical device manufacturers must rely on across the three phases of process validation -- Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).

A key section of the FDA’s Quality System Regulations, specifically 21 CFR part 820, states that:

"Where appropriate, each manufacturer shall establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics."

In this webinar, Heath Rushing, Principal Consultant at Adsurgo, provides a detailed examination of the use of statistical methods in ensuring successful compliance with process validation requirements for medical device manufacturers across IQ, OQ and PQ.

Specifically, you will learn:  

  • How to conduct a capability study.
  • How to develop a control chart.
  • How to use design of experiments to determine critical process parameters.
  • How to manage risk with failure modes and effects analysis (FMEA).
  • How to use a Gauge R&R study to ensure that you have an accurate, precise and stable measurement system.
  • How to use a response surface study to determine the functional relationship between inputs and outputs.
  • How quality by design methodology can be used as a framework to ease the pain of process validation.

 

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JMP Capabilities Ideal for Medical Device Engineers

  • Design of Experiments

    Actively manipulate factors according to a pre-specified design to quickly and easily gain useful, new understanding.

  • Statistical Process Control

    Separate common and special causes to assist your process analysis efforts, including problem investigation, out-of-control conditions and ongoing monitoring for stability.

  • Quality by Design (QbD)

    Identify and evaluate all sources of variability with respect to quality parameters of the finished product. 

  • Robust Optimization

    Find the ‘sweet spot’ in the design where performance is minimally sensitive to variation for all critical quality attribute (CQA) goals in your process, following ICH Q11 guidelines.

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