Interpretation of FDA's Quality System Regulations (QSR) With QSIT references
	Copyright 2006,   328 pages ISBN 0-9780704-0-2	To see free excerpts from this book - listed in Google Books  Click Here
		A complete compendium to FDA's Quality System Regulation (QSR) with relative references to FDA's Quality System Inspection Technique (QSIT).  This 2006 version book takes into account the latest up-to-date trends in Agency views. You will want to keep this book in reach when: 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)! Note to cut down on production costs and pass on the savings to our customers, we are only offering PDF versions at this time. List Price: $ 99.00 USD  Who should have this book? Quality Assurance Managers/Specialists Regulatory Affairs Managers/Specialists Production/Process Managers Marketing/Sales staff FDA auditors Management with Executive Responsibility Complaint Handling Personnel CAPA Personnel     Note: you will need a PDF reader.  If you don't have one you can download one for free.