A History of a Cgmp Medical Event Investigation ePub (Adobe DRM) download by Mark A. Brown

A History of a Cgmp Medical Event Investigation

Wiley
Publication date: November 2012
ISBN: 9781118494882
Digital Book format: ePub (Adobe DRM)

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This book explains the application of the FDA Investigational and New Drug application process, FDA Current Good Manufacturing Practice regulations (cGMP) and Design for Six Sigma (DMADV) in the identification of Customer Requirements, Measurement and Analysis, Design Specifications, and Process Verification and Product Validation. The Six Sigma methodologies are discussed with examples in preparation of a Project Charter with a supplied format; how to manage and document a team meeting; examples of the application of Failure Mode Effect Analysis (FMEA), Quality Functional Deployment (QFD), and the Design Fish-Bone Diagram applied in the design of a coffee cup; an explanation of capability indexes (Cp, Ppk, Cpk) including an example of a Design Of Experiments (DOE) based on improving the capability of a molding operation; and a DMAIC Investigation specific to identifying the cause of failure implicated in the case.
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A History of a Cgmp Medical Event Investigation ePub (Adobe DRM) download by Mark A. Brown
Wiley, November 2012
ISBN: 9781118494882
EAN:  9781118494882
ePub (Adobe DRM)
eBook price: $33.99
A History of a Cgmp Medical Event Investigation PDF (Adobe DRM) download by Mark A. Brown
Wiley, December 2012
ISBN: 9781118494936
EAN:  9781118494936
PDF (Adobe DRM)
eBook price: $33.99