{"product_id":"preparing-for-fda-pre-approval-inspections-martin-d-hynes-9780367452711","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\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Martin D. Hynes\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 0367452715\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9780367452711\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e CRC Press\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 12\/02\/2019\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 304\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Paperback\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 0.89lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 9.00h x 6.00w x 0.63d","brand":"Martin D. Hynes","offers":[{"title":"Paperback","offer_id":48443396161791,"sku":"9780367452711","price":87.99,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_9374918a-c278-4d9b-be4f-9b07832a4b67.jpg?v=1777205245","url":"https:\/\/www.whiterainbookhouse.com\/products\/preparing-for-fda-pre-approval-inspections-martin-d-hynes-9780367452711","provider":"WR Book House","version":"1.0","type":"link"}