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Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance
0Original price was: ₹3,995.00.₹3,196.00Current price is: ₹3,196.00.Ensure FDA, GMP, and GLP compliance with the Pharmaceutical Master Validation Plan. This essential guide from The Bookish Owl is your roadmap to successfully starting up new facilities or validating existing ones, significantly reducing the risk of FDA application rejection. Discover proven strategies to achieve U.S. market authorization, pass inspections, and minimize costly non-conformance and recalls. Essential for pharmaceutical, medical device, and biotech companies worldwide, this book, paired with its customizable CD template, equips you with everything needed to develop and execute a robust validation plan, leading to smoother approvals and higher product quality.
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QUALITY OPERATIONS PROCEDURES FOR PHARMACEUTICAL APL AND BIOTECHNOLOGY (HB 2012)
0₹10,920.00Ensure regulatory compliance with “Quality Operations Procedures for Pharmaceutical API and Biotechnology” available at The Bookish Owl. This essential guide, authored by Syed Imtiaz Haider (ISBN: 9781439886908), provides crucial insights into creating quality SOPs for pharmaceutical, medical, and biotech companies. Covering FDA, EU GMP, and ISO 9000 standards, this book offers practical templates (CD-ROM included!) to tailor SOPs and streamline quality control & assurance. Minimize audit risks, enhance productivity, and navigate global regulatory landscapes effortlessly. Perfect for pharmaceutical professionals seeking to optimize operations and maintain impeccable documentation. Get your copy at The Bookish Owl today and simplify your compliance journey.
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Validation Standard Operating Procedures 2Ed (Hb 2009): A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, And Biotech Industries
0Original price was: ₹3,995.00.₹3,196.00Current price is: ₹3,196.00.Discover comprehensive validation guidance with ‘Validation Standard Operating Procedures 2Ed (Hb 2009)’ from The Bookish Owl. This essential step-by-step guide ensures compliance for pharmaceutical, medical device, and biotech industries. Covering critical validation elements for non-aseptic and aseptic production, it features 14 environmental performance evaluations and 64 new protocols. Explore topics like sterility assurance, media fill guidelines, and environmental control. Perfect for professionals seeking to achieve regulatory adherence and streamline validation processes. Enhance your understanding and implement best practices with this indispensable resource for the life sciences sector. Buy your copy today for expert insights into validation excellence.
