{"product_id":"how-to-develop-and-manage-qualification-protocols-for-fda-compliance-hardback","title":"How to Develop and Manage Qualification Protocols for FDA Compliance - Hardback","description":"\u003cp\u003eAll current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and ISO 9000 standards and regulations require that validation document be established and followed. Yet these regulations do not provide guidelines on how to produce documentation such as qualification protocols.\u003cbr\u003e\u003cbr\u003eHow to Develop and Manage Qualification Protocols for FDA Compliance focuses specifically on the FDA documentation requirements, providing concrete guidance on how to develop and manage qualification protocols and their associated documentation to ensure your company is not at risk.\u003cbr\u003e\u003cbr\u003eKey function areas, such as cleaning, facilities and utilities, equipment, computers and software, and process are discussed in detail. The book contains 35 validation procedures and 30 forms that can be used to establish a validation documentation system and provides protocol templates you can use as your own. Numerous diagrams and graphics are used to illustrate key points.\u003cbr\u003e\u003cbr\u003eMost importantly, this book will provides hands-on, \"been there\" advice on how to:\u003c\/p\u003e\u003cli\u003eWrite protocols and final reports\u003cbr\u003e \u003c\/li\u003e\u003cli\u003eDevelop protocol formats and style guides\u003cbr\u003e \u003c\/li\u003e\u003cli\u003eEstablish a documentation review and approval system\u003cbr\u003e \u003c\/li\u003e\u003cli\u003eImplement document control and forms control programs\u003cbr\u003e \u003c\/li\u003e\u003cli\u003eMigrate your documentation system from paper to electronic format\u003cbr\u003e\u003cbr\u003eIf your responsibilities include writing and managing qualification protocols for drug products and related industries, here's all you need to build a cost-effective, manageable--and compliant--system.\u003c\/li\u003e","brand":"Taylor \u0026 Francis","offers":[{"title":"Default Title","offer_id":45575900496110,"sku":"9781574910988","price":80.8,"currency_code":"AUD","in_stock":true}],"url":"https:\/\/bookland.com.au\/products\/how-to-develop-and-manage-qualification-protocols-for-fda-compliance-hardback","provider":"Book Land AU","version":"1.0","type":"link"}