DRUG REGULATORY AFFAIRS &...
Rs.191.25
The book Drug Regulatory Affairs and Validation guides analysts, laboratory managers, quality assurance managers, and validation professionals through the validation and qualification process in analytical laboratories. The validation and qualification procedures help to ensure compliance and quality, but with minimal extra cost and administrative complexity. The recommendations are complementary rather than contradictory to any regulations, standards, or official guidelines. They are based mainly on common sense and can be used in cases where information from official guidelines and standards is insufficient for day to day work
Description
- This book addresses international and national regulations and quality standards.
- Its concept, examples, operation procedures and templates are based on my more than twenty years of multinational experience and incorporate all aspects of validation in use at the top companies in these fields.
- Input has been taken from personal discussions with managers, chemists at laboratories, corporate quality assurance managers, quality control managers, and vendors of equipment and chemicals.
- This book will learn how to speed up their validation and qualification processes, to avoiding troublesome costly, reworking, and gaining confidence for audits and inspections.
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ISBN: NA YEAR: 2009 EDITION: 2016 BINDING: PAPERBACK PUBLISHER: VPD AUTHOR: KAUSHAL K.CHANDRUL
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