Quality by Design and the Life Sciences
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.