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Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition

This Second Edition is an essential guide to preparing for FDA pre-approval inspections—taking into account current trends in FDA expectations and inspection activities, such as the GMPs of the 21st Century, quality systems-based approach to inspections, risk-based inspections, quality by design, process analytical technology, design space, etc. The goal of this book is to help organizations gain rapid regulatory approval.

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Posted in books by kdsaggi on Aug. 16, 2008 // 06:38 | Comments (0)
SAP R/3 for Everyone : Step-by-Step Instructions, Practical Advice, and Other Tips and Tricks for Working with SAP

SAP R/3 for Everyone is the nontechnical user’s guide to working with SAP R/3, the leading business enterprise software product in the world. Written and road-tested by experienced SAP R/3 users and trainers, this book saves typical SAP R/3 users time and trouble by providing them with the universal skills needed to work with any module of this complex software.

 

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Posted in books by kdsaggi on Aug. 16, 2008 // 09:19 | Comments (0)
SAP NetWeaver For Dummies

Imagine that it’s the 1950s, and you are in charge of developing the U. S. interstate system. There are countless roads already in use. The system can go in numerous different directions. Where do you begin?

 

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Posted in books by kdsaggi on Aug. 16, 2008 // 09:20 | Comments (0)
SAP Query Reporting

SAP Query Reporting is everything an SAP user needs to know to create your own reports in SAP using Query tools, no programming required! Designed as a hands-on learning aid, you will be able to follow along and perform each new skill learned on your own SAP system. The book’s tutorial style, step-by-step instruction will teach you everything you need to know to use the SAP Query tools, including its configuration, advanced usage, and integration to Microsoft. Additionally the book gives best business practice recommendations for the technology and internal business use of the tools. Learn to:

  • Understand query security, table reads, and table joins
  • Perform basic and advanced calculations
  • Incorporate pictures and graphics into reports
  • Configure shortcuts and tran codes, schedule jobs and email PDFs
  • Utilize SAP Reporting with Microsoft Office applications

 

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Posted in books by kdsaggi on Aug. 16, 2008 // 09:22 | Comments (0)
SAP(R) BW: A Step-by-Step Guide

This book is a how-to guide. It uses step-by-step procedures with captured screen shots to illustrate SAP BW’s functionalities. Although the book focuses on the core SAP BW technology, it also discusses other SAP technologies, such as Basis, ABAP (Advanced Business Application Programming), and ALE (Application Link Enabling) when necessary. It does not, however, discuss third-party reporting tools and BAPI (Business Application Programming Interface). Intended Audience This book is written for BW implementation teams and other individuals who need a product to understand the data warehousing concept. Prerequisites BW is built on the Basis 3-tier architecture and coded in the ABAP language. ALE and BAPI are used to link BW with SAP systems (R/3 or BW) and non-SAP systems. This book, however, does not require readers have knowledge in these areas. Instead, BW has made the development of a data warehouse so easy that people with minimal experience in database design and computer programming can use it. Book Structure This book is organized into two parts: Part I contains guided tours. We start from a simplified business scenario, then illustrate how to create an InfoCube, load data into the InfoCube, check the accuracy of the loaded data, create queries to generate reports, and manage user authorization. Part II focuses on advanced topics, such as InfoCube design techniques, aggregates, multi-cubes, operational data store (ODS), Business Content, generic R/3 data extraction, data maintenance, performance tuning, and object transport. The appendices introduce ASAP (Accelerated SAP) for BW, one of the derivatives of the ASAP implementation methodology developed by SAP, and give an overview of the Basis 3-tier architecture.

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Posted in books by kdsaggi on Aug. 16, 2008 // 12:57 | Comments (0)