{"product_id":"preparing-for-fda-pre-approval-inspections-a-guide-to-regulatory-success-second-edition-9780367452711","title":"Preparing for FDA Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition","description":"\u003cp\u003e • Author(s): Martin D. Hynes\u003cbr\u003e • Publisher: Taylor \u0026amp; Francis\u003cbr\u003e • Publisher Imprint: CRC Press\u003cbr\u003e • BISAC: Pharmacology\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003eThis \u003cstrong\u003e\u003cem\u003eSecond Edition\u003c\/em\u003e\u003c\/strong\u003e is an essential guide to preparing for FDA pre-approval inspections--taking into account current trends in FDA expectations and inspection activities, such as the GMPs of the 21st Century, quality systems-based approach to inspections, risk-based inspections, quality by design, process analytical technology, design space, etc. The goal of this book is to help organizations gain rapid regulatory approval.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003e\u003cem\u003ePharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition\u003c\/em\u003e\u003c\/strong\u003e: \u003c\/p\u003e\u003cul\u003e \u003cli\u003echronicles the major shifts in inspection activity as evidenced by a systems-based approach to inspections\u003c\/li\u003e \u003cli\u003edemonstrates what each area of pharmaceutical development, from research and development to training, is expected to provide to inspectors\u003c\/li\u003e \u003cli\u003efocuses on traditional development and submission activities, but also discusses cases where the transfer is from a domestic site to an international facility\u003c\/li\u003e \u003c\/ul\u003e","brand":"Taylor \u0026 Francis","offers":[{"title":"Paperback","offer_id":45240018927767,"sku":"9780367452711","price":5478.0,"currency_code":"INR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0666\/3471\/1191\/files\/9780367452711.webp?v=1769224259","url":"https:\/\/atlanticbooks.com\/products\/preparing-for-fda-pre-approval-inspections-a-guide-to-regulatory-success-second-edition-9780367452711","provider":"Atlantic Books","version":"1.0","type":"link"}