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What's
on the Validation Report?
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An Overview of FDA Expectations
Listen in to Roberta as she outlines critical watch points regarding QSR compliance.
The 483 warning process is explained during her rich dialogue.
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IQ OQ PQ Process
This is the heart of the medical device packaging validation process. This regulatory
matrix is clearly explained to provide general guidance.
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The Taguchi Method
Follow along with the provided chart as Roberta explains the valuable statistical
tool known as the Taguchi Method.
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In-house
Validation Support
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Charlie A. Webb, BS, CPP, CMC, our validation team leader
is a graduate from the University of Redlands with a bachelor's degree
in management and is also a Certified Consultant to Management through
the Institute
of Management Consultants, IMC, and is our on-staff CPP, Certified Packaging
Professional. Charlie spent the past 20 years in the medical device manufacturing
industry.
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Outsourced
Validation Support
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Roberta Goode, MSBE, CQE, President of Goode Consulting International,
Inc., specializes in training, validation, and compliance services for
FDA-regulated industries. In addition to a graduate degree in biomedical engineering,
she
has over fifteen years’ experience in research and development, quality
assurance, manufacturing engineering and regulatory affairs.
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