Download PDF Straight Talk on Process Validation, by Jayme Lahey, Robert Launsby, Suhas Kulkarni, Thomas Oesterle
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Straight Talk on Process Validation, by Jayme Lahey, Robert Launsby, Suhas Kulkarni, Thomas Oesterle
Download PDF Straight Talk on Process Validation, by Jayme Lahey, Robert Launsby, Suhas Kulkarni, Thomas Oesterle
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"Straight Talk on Process Validation" clears up the confusion concerning process validation by providing a simple step-by-step approach for an organization to follow to ensure an effective implementation of process validation. This book includes several examples, written at various levels, which delineate the details of process validation of actual processes.
- Sales Rank: #459229 in eBooks
- Published on: 2012-11-07
- Released on: 2012-11-07
- Format: Kindle eBook
Most helpful customer reviews
2 of 2 people found the following review helpful.
Must have book if you are involved in IQ, OQ, PQ !!
By Jaime Alvarez
Having been involved in validations & Quality Technology Systems like FMEA and SPC, for the past few years and having worked in the injection molding industry I wanted to thoroughly understand the validation process for the medical industry. I found Bob's book on this topic to be exactly what I was looking for. He has brought out the essence of validation clearly with his lucidly written text. We have been offering our FMEA software predominantly to the automotive industry. The detailed treatment given to FMEA in this book has highlighted the needs of the medical industry very clearly. It identifies well with what we have been offering the industry. The book also helped me understand what the FDA requirements are. These are usually not clearly understood by non-US companies. I highly recommend this book to those who would want to understand this subject.
0 of 0 people found the following review helpful.
Straight Talk on Process Validation
By Brent Borgerson
The authors present process validation (PV) in an easy to understand format. Since PV is, or should be a result of a cross-functional team effort, the book can be understood by people who are not statisticians.
An excellent training resource.
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