Suchergebnisse

Cover -- Title page -- CIP data -- Table of Contents -- List of Figures and Tables -- Preface -- List of Acronyms -- Chapter 1-Introduction -- Facts About cGMP -- cGMP and the Quality System -- Notes -- Chapter 2-US Current Good Manufcturing Practice -- cGMP and The FDA -- Drugs Regulated by CDER -- Foreign Manufacturers -- Notes -- Chapter 3-International Good Manufacturing Practice -- The EU -- Canada -- Japan -- Brazil -- Australia -- China -- India -- Korea -- South Africa -- Russia -- New Zealand -- Notes -- Chapter 4-Global Good Manufacturing Practice Guides and Harmonization -- The WHO -- International Conference on Harmonization -- Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Co-operation Scheme -- Notes -- Chapter 5-Details Analysis of the Requirements and Guidances -- Part 210-Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs: General -- Part 211-Current Good Manufacturing Practice for Finished Pharmaceuticals -- Notes -- Chapter 6-Missing Subparts -- Corrective and preventive action system -- Management Control -- Process Validations -- Notes -- Chapter 7-What Are Inspectors Looking For? -- Types of Inspections -- Drug Manufacturing Inspections -- Preapproval Inspection -- API Inspections -- Sterile Drug Process Inspection -- Notes -- Chapter 8-Quality at Risk: The Price of Noncompliance -- Field Alerts -- Recall Process for FDA-Regulated Products -- Form 483 -- Regulatory Meetings -- Dear Health Care Provider Letter -- Untitled and Warning Letters -- Criminal Investigations -- Seizure -- Injunctions -- Consent Decrees and Disgorgements -- Debarment and Disqualification List -- Progressive Enforcement -- Notes -- Appendix-At-a-Glance Comparisons -- Bibliography -- Useful Websites -- Index.

The development of knowledge-based systems is usually approached through the combined skills of knowledge engineers (KEs) and subject matter experts (SMEs). One of the most critical steps in this activity aims at transferring knowledge from SMEs to formal, machine-readable representations, which allow systems to reason with such knowledge. However, this is a costly and error prone task. Alleviating the knowledge acquisition bottleneck requires enabling SMEs with the means to produce the desired knowledge representations without the help of KEs. This is especially difficult application domains uncovers that process knowledge is one of the most freqent knowledge types, whose complexity requires specific means to enable SMEs to represent processes in a computational form. Additionally, such complexity and the increasigly large amount of data that process executions generate in knowledge-intensive domains, like Biology or Astronomy, requires analytical means with high abstraction capabilities to support SMEs in the analysis of such processes. This book presents methods and tools that enable SMEs to acquire process knowledge from the domains, formally represent such knowledge, reason about it, and understand process executions by analyzing their provenance. We describe the utilization of Problem Solving Methods as the main knowledge artifacts for process acquisition and analysis in two innovative ways. First, as formalizations of the reasoning strategies needed for processes and, second, as high-level, domain-independent, and reusable abstractions of process knowledge to provide SMEs with interpretati-ons of process executions--P.4 of cover.