{"product_id":"9781032926735","title":"Writing and Managing SOPs for GCP","description":"\u003ch1\u003eWriting and Managing SOPs for GCP\u003c\/h1\u003e\u003ch3\u003eSusanne Prokscha\u003c\/h3\u003e\u003cdiv\u003e\u003cb\u003eBusiness \u0026amp; Economics \/ Quality Control\u003c\/b\u003e\u003c\/div\u003e\u003cbr\u003e\u003cdiv\u003e\n\u003cp\u003e\u003cstrong\u003eWriting and Managing SOPs for GCP\u003c\/strong\u003e is\u003cb\u003e \u003c\/b\u003ethe first book to discuss managing Standard Operating Procedures (SOPs) for Good Clinical Practice (GCP) from conception to retirement. It recommends approaches that have a direct impact on improving SOP and regulatory compliance. Throughout the text, the book provides a user’s point of view to keep topics focused on the practical aspects of SOPs and SOP management.\u003c\/p\u003e\n\u003cp\u003eThe idea of specifically calling out approaches to SOP creation and maintenance in an effort to make it easier for users to stay in compliance is a theme found throughout all book chapters. Examples in each chapter provide accurate reflections of real-world experiences to illustrate the discussion. The book also includes an example \"SOP of SOPs\" along with an associated SOP template.\u003c\/p\u003e\n\u003c\/div\u003e\u003cdiv\u003e\u003cp\u003e\u003cstrong\u003eSusanne Prokscha\u003c\/strong\u003e is a director in clinical data management for process and training at Onyx Pharmaceuticals in San Francisco, California. She\u003cb\u003e \u003c\/b\u003ehas been involved in clinical data management (CDM) processes and technologies since the mid-1980s. Ms. Prokscha has worked both as a consultant and directly for large and small companies, gaining experience with a wide range of studies and a variety of clinical data management systems. Her interest in advancing the field of CDM and helping emerging CDM groups led her to write \u003ci\u003ePractical Guide to Clinical\u003c\/i\u003e \u003ci\u003eData Management\u003c\/i\u003e.\u003cb\u003e \u003c\/b\u003eShe currently focuses on process development, SOP writing, document management, and training for CDM and Biometrics groups. \u003c\/p\u003e\u003c\/div\u003e\u003cbr\u003e\u003ctable\u003e\n\u003ctr\u003e\n\u003ctd\u003ePublication Date: \u003c\/td\u003e\n\u003ctd\u003e14 October 2024\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003ePublisher: \u003c\/td\u003e\n\u003ctd\u003eCRC Press\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eImprint: \u003c\/td\u003e\n\u003ctd\u003eCRC Press\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eISBN-13: \u003c\/td\u003e\n\u003ctd\u003e9781032926735\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eFormat: \u003c\/td\u003e\n\u003ctd\u003ePaperback softback\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003ePage Count: \u003c\/td\u003e\n\u003ctd\u003e224\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eWeight (oz): \u003c\/td\u003e\n\u003ctd\u003e16.0\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/table\u003e","brand":"CRC Press","offers":[{"title":"Default Title","offer_id":63536292724876,"sku":"9781032926735","price":61.19,"currency_code":"USD","in_stock":true}],"url":"https:\/\/lateknightbooks.com\/products\/9781032926735","provider":"Late Knight Books and Services, LLC","version":"1.0","type":"link"}