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Opis

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.

Szczegóły książki

Kategoria Książki po angielsku Technology, engineering, agriculture Industrial chemistry & manufacturing technologies Industrial chemistry

• Pełny tytuł: History of a cGMP Medical Event Investigation
• Autor: Mark A Brown
• Język: Angielski
• Oprawa: Miękka
• Liczba stron: 252
• EAN: 9781118396612
• ISBN: 1118396618
• ID: 01250373
• Wydawca: John Wiley & Sons Inc
• Waga: 328 g
• Wymiary: 235 × 156 × 17 mm
• Data wydania: 30. November 2012

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