{"product_id":"change-control-for-fda-regulated-industries-a-risk-assesment-approach-hardcover","title":"Change Control for FDA Regulated Industries: A Risk Assesment Approach - Hardcover","description":"\u003cdiv\u003e\u003cp style=\"text-align: right;\"\u003e\u003ca href=\"https:\/\/reportcopyrightinfringement.com\/\" target=\"_blank\" rel=\"nofollow\"\u003e\u003cb\u003eReport copyright infringement\u003c\/b\u003e\u003c\/a\u003e\u003c\/p\u003e\u003c\/div\u003e\u003cp\u003eby \u003cb\u003eDavid N. Muchemu\u003c\/b\u003e (Author)\u003c\/p\u003e\u003cp\u003eThis 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 requirements\u003c\/p\u003e\n            \u003cdiv\u003e\n\u003cstrong\u003eNumber of Pages:\u003c\/strong\u003e 148\u003c\/div\u003e\n            \u003cdiv\u003e\n\u003cstrong\u003eDimensions:\u003c\/strong\u003e 0.5 x 9 x 6 IN\u003c\/div\u003e\n            \u003cdiv\u003e\n\u003cstrong\u003ePublication Date:\u003c\/strong\u003e October 13, 2007\u003c\/div\u003e\n            ","brand":"BooksCloud","offers":[{"title":"Default Title","offer_id":52617959833907,"sku":"9781434314680","price":60.55,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0300\/5595\/6612\/files\/oHNywJTjdI9781434314680.webp?v=1761897199","url":"https:\/\/www.vysn.com\/en-ca\/products\/change-control-for-fda-regulated-industries-a-risk-assesment-approach-hardcover","provider":"VYSN","version":"1.0","type":"link"}