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A complete compendium to the Food and Drug Administration's (FDA) Quality System Regulation (QSR) with relative references to FDA's Quality System Inspection Technique (QSIT). This book takes into account the latest up-to-date trends in Agency views.

Soft Cover: Sorry Currently Out of Stock:  $247.00

• Developing policies and procedures
• Preparing for FDA audits
• Responding to 483 Observations and Warning Letters
  Conducting Internal Audits or determining Gap Analysis

Each chapter restates the requirement, then leads into an interpretation/discussion of the important sections. Relevant portions also include:

• Industry Practices
• Definition Checks
• Cautionary remarks
• QSIT Reference (understanding exactly what the FDA will concentrate on during audits - and the sorts of questions they will ask)
• Available for immediate download (electronic PDF version)!