{"product_id":"change-control-for-fda-regulated-david-n-muchemu-9781434314680","title":"Change Control for FDA Regulated Industries: A Risk Assesment Approach","description":"This book accomplishes the following: .It addresses requirements for Pharmaceutical, Medical Device, Biologics, and Tissue banking change control .Defines the different phases of the change control life cycle .Establishes the relationship between risk management, cost of doing business and change control .Defines regulatory requirements for change control, including requirements for (510k) submission .Provides tools for risk assesment, and cost\/benefit analysis .Helps the reader design a Change control system that meets and exceeds cGMP requir\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e David N. Muchemu\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 1434314685\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9781434314680\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e Authorhouse\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 10\/13\/2007\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 148\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Hardcover\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 0.83lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 9.00h x 6.00w x 0.50d","brand":"David N. Muchemu","offers":[{"title":"Hardcover","offer_id":43934946984191,"sku":"9781434314680","price":35.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/products\/img_eaee8974-de3a-4611-8e4b-6a1d83b48d79.jpg?v=1681416968","url":"https:\/\/www.whiterainbookhouse.com\/products\/change-control-for-fda-regulated-david-n-muchemu-9781434314680","provider":"WR Book House","version":"1.0","type":"link"}