{"product_id":"preparing-for-fda-pre-approval-inspections-martin-d-hynes-9780849391842","title":"Preparing for FDA Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition","description":"\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\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Martin D. Hynes\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 0849391849\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9780849391842\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e CRC Press\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 03\/05\/2008\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 304\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Hardcover\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 1.19lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 9.25h x 6.43w x 0.80d","brand":"Martin D. Hynes","offers":[{"title":"Hardcover","offer_id":48112986751231,"sku":"9780849391842","price":255.0,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_7a72e16c-9bd1-4163-bbe1-f0b2f3dddc65.jpg?v=1769612289","url":"https:\/\/www.whiterainbookhouse.com\/products\/preparing-for-fda-pre-approval-inspections-martin-d-hynes-9780849391842","provider":"WR Book House","version":"1.0","type":"link"}