Medical Device Process Validation
Meet FDA requirements by learning the principles of process validation for medical devices. Implementing principles and practices that are consistent with current FDA guidelines and requirements does not have to be an overwhelming task.
Our “to the point” training takes the mystery out of FDA requirements and provides you with common sense, cost effective approaches for your process validation efforts.
Our approach, highlighted in our text “Straight Talk on Process Validation” was authored by a cross-section of leading experts in the field. The book offers an easy to follow, step-by-step approach to medical device process validation.
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Why Launsby Consulting?
We have consulted with and trained numerous organizations in the principle and application of PV tools and techniques since the late 1990's. Working with a team of industry experiments we authored the text "Straight Talk on Process Validation" in 2012. The first text in the field to tie statistical tools and design of experiments to the fundamental phases of medical device process validation (IQ, OQ, PQ, PPQ). Our training session are lively, entertaining, and practically oriented.
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Prerequisites:
A basic familiarity with FDA guiding documents on Process Validation and Design Control
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Length of session:
2 day session
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What you will learn:
The purpose of a Master Validation Plan
The regulatory requirements for IQ, OQ, PQ
How to execute each phase to comply with the regulatory requirements
The minimum and mandatory content for test protocols and test reports
The required number of OQ runs
The required number of PQ runs
The number of samples needed to measure/test/inspect for OQ and PQ
What is needed to maintain the validated state
Understanding of risk-based process validation
The expectations for TMV (Test Method Validation)
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In house or remote-in-person online training.
Contact us today for more information.