{"product_id":"laboratory-control-system-operations-in-a-gmp-environment-isbn-9781119529231","title":"Laboratory Control System Operations in a GMP Environment","description":"\u003cp\u003e\u003cb\u003eDevelop an understanding of FDA and global regulatory agency requirements for Laboratory Control System (LCS) operations\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eIn \u003ci\u003eLaboratory Control System Operations in a GMP Environment\u003c\/i\u003e, readers are given the guidance they need to implement a CGMP compliant Laboratory Control System (LCS) that fits within Global Regulatory guidelines. Using the Quality Systems Approach, regulatory agencies like the FDA and the European Medicine Agency have developed a scheme of systems for auditing pharmaceutical manufacturing facilities which includes evaluating the LCS. In this guide, readers learn the fundamental rules for operating a CGMP compliant Laboratory Control System.\u003c\/p\u003e \u003cp\u003eDesigned to help leaders meet regulatory standards and operate more efficiently, the text includes chapters that cover Laboratory Equipment Qualification and Calibration, Laboratory Facilities, Method Validation and Method Transfer, Laboratory Computer Systems, Laboratory Investigations as well as Data Governance and Data Integrity. The text also includes chapters related to Laboratory Managerial and Administrative Systems, Laboratory Documentation Practices and Standard Operating Procedures and General Laboratory Compliance Practices.  Additionally, a chapter outlining Stability Program operations is included in the text.\u003c\/p\u003e \u003cp\u003eIn addition to these topics, it includes LCS information and tools such as:\u003c\/p\u003e \u003cp\u003e●      End of chapter templates, checklists, and LCS guidance to help you follow the required standards\u003c\/p\u003e \u003cp\u003e●      Electronic versions of each tool so users can use them outside of the text\u003c\/p\u003e \u003cp\u003e●      An In-depth understanding of what is required by the FDA and other globally significant regulatory authorities for GMP compliant systems\u003c\/p\u003e \u003cp\u003eFor quality assurance professionals working within the pharmaceutical or biopharma industries, this text provides the insight and tools necessary to implement government-defined regulations.\u003c\/p\u003e \u003cp\u003ePreface xi\u003c\/p\u003e \u003cp\u003eAbout the Companion Website xvii\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Introduction to the Quality Systems Based Approach to CGMP Compliance \u003c\/b\u003e\u003cb\u003e1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eOverview of Quality Systems and the Laboratory Control System 1\u003c\/p\u003e \u003cp\u003eRegulations and Regulatory Bodies 4\u003c\/p\u003e \u003cp\u003eRegulatory Guidance 4\u003c\/p\u003e \u003cp\u003eApplication of This Text 5\u003c\/p\u003e \u003cp\u003eOverlap and Redundancy 6\u003c\/p\u003e \u003cp\u003eTools and Templates 6\u003c\/p\u003e \u003cp\u003eReferences 7\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 Components of the Laboratory Managerial and Administrative Systems Sub Element (MS) \u003c\/b\u003e\u003cb\u003e9\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eDescription of the Laboratory Managerial and Administrative Systems Sub Element 9\u003c\/p\u003e \u003cp\u003eContents of the Sub Element 10\u003c\/p\u003e \u003cp\u003eTools and Templates 23\u003c\/p\u003e \u003cp\u003eReference 23\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Components of the Laboratory Documentation Practices and Standard Operating Procedures Sub Element (OP) \u003c\/b\u003e\u003cb\u003e25\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eDescription of the Laboratory Documentation Practices and Standard Operating Procedures Sub Element 25\u003c\/p\u003e \u003cp\u003eContents of the Sub Element 26\u003c\/p\u003e \u003cp\u003eTools and Templates 44\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Components of the Laboratory Equipment Sub Element (LE) \u003c\/b\u003e\u003cb\u003e45\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eDescription of the Laboratory Equipment Sub Element 45\u003c\/p\u003e \u003cp\u003eContents of the Sub Element 46\u003c\/p\u003e \u003cp\u003eTools and Templates 68\u003c\/p\u003e \u003cp\u003eReferences 68\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Components of the Laboratory Facilities Sub Element (LF) \u003c\/b\u003e\u003cb\u003e71\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eDescription of the Laboratory Facilities Sub Element 71\u003c\/p\u003e \u003cp\u003eContents of the Sub Element 71\u003c\/p\u003e \u003cp\u003eTools and Templates 81\u003c\/p\u003e \u003cp\u003eReferences 81\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Components of the Method Validation and Method Transfer Sub Element (MV) \u003c\/b\u003e\u003cb\u003e83\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eDescription of the Method Validation and Method Transfer Sub Element 83\u003c\/p\u003e \u003cp\u003eContents of the Sub Element 84\u003c\/p\u003e \u003cp\u003eTools and Templates 93\u003c\/p\u003e \u003cp\u003eGlossary 93\u003c\/p\u003e \u003cp\u003eReferences 113\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Components of the Laboratory Computer Systems Sub Element (LC) \u003c\/b\u003e\u003cb\u003e115\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eDescription of the Laboratory Computer Systems Sub Element 115\u003c\/p\u003e \u003cp\u003eContents of the Sub Element 116\u003c\/p\u003e \u003cp\u003eTools and Templates 129\u003c\/p\u003e \u003cp\u003eGlossary 130\u003c\/p\u003e \u003cp\u003eReferences 133\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Components of the Laboratory Investigations Sub Element (LI) \u003c\/b\u003e\u003cb\u003e135\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eBackground and Regulatory History of Out-of-Specification Investigations 135\u003c\/p\u003e \u003cp\u003eDescription of the Laboratory Investigations Sub Element 135\u003c\/p\u003e \u003cp\u003eContents of the Sub Element 139\u003c\/p\u003e \u003cp\u003eCommon Problems Related to Laboratory OOS Investigations 148\u003c\/p\u003e \u003cp\u003eTools and Templates 149\u003c\/p\u003e \u003cp\u003eGlossary 150\u003c\/p\u003e \u003cp\u003eReferences 155\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 Components of the Laboratory Data Governance and Data Integrity Sub Element (DI) \u003c\/b\u003e\u003cb\u003e157\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eBackground 157\u003c\/p\u003e \u003cp\u003ePrecepts Regarding Data Governance and Data Integrity 159\u003c\/p\u003e \u003cp\u003eDescription of the Laboratory Data Governance and Data Integrity Sub Element 162\u003c\/p\u003e \u003cp\u003eContents of the Sub Element 164\u003c\/p\u003e \u003cp\u003ePolicy for Data Governance 164\u003c\/p\u003e \u003cp\u003eProcedural Controls 165\u003c\/p\u003e \u003cp\u003eTechnical Controls 166\u003c\/p\u003e \u003cp\u003eData Maps and Data Walks 166\u003c\/p\u003e \u003cp\u003eRisk Identification, Ranking, and Filtering 171\u003c\/p\u003e \u003cp\u003eData Reviews 196\u003c\/p\u003e \u003cp\u003eData and Operational Audits 196\u003c\/p\u003e \u003cp\u003eEmployee Awareness and Training 208\u003c\/p\u003e \u003cp\u003eManagement Oversight 210\u003c\/p\u003e \u003cp\u003eTools and Templates 212\u003c\/p\u003e \u003cp\u003eGlossary 212\u003c\/p\u003e \u003cp\u003eReferences 214\u003c\/p\u003e \u003cp\u003eFurther Reading 215\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 Components of the Stability Program Sub Element (SB) \u003c\/b\u003e\u003cb\u003e217\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eDescription of the Stability Program Sub Element 217\u003c\/p\u003e \u003cp\u003eContents of the Sub Element 218\u003c\/p\u003e \u003cp\u003eModel Standard Operating Procedures for Establishing and Maintaining a Stability Program 218\u003c\/p\u003e \u003cp\u003eStability Chambers 246\u003c\/p\u003e \u003cp\u003eTools and Templates 261\u003c\/p\u003e \u003cp\u003eGlossary 262\u003c\/p\u003e \u003cp\u003eReferences 268\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11 Components of the General Laboratory Compliance Practices Sub Element (CP) \u003c\/b\u003e\u003cb\u003e269\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eDescription of the General Laboratory Compliance Practices Sub Element 269\u003c\/p\u003e \u003cp\u003eContents of the Sub Element 270\u003c\/p\u003e \u003cp\u003eTools and Templates 284\u003c\/p\u003e \u003cp\u003e\u003cb\u003e12 Summary for Establishing and Maintaining a Laboratory Control System \u003c\/b\u003e\u003cb\u003e285\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eA Brief Review of the Laboratory Control System and Its Sub Elements 285\u003c\/p\u003e \u003cp\u003eHow Things Can Go Wrong: Examples of Some Regulatory Citations Organized by Sub Element 285\u003c\/p\u003e \u003cp\u003eSome Final Thoughts on Establishing and Maintaining a Compliance Laboratory Control System 296\u003c\/p\u003e \u003cp\u003eIndex 297\u003c\/p\u003e  \u003cp\u003e\u003cb\u003eDAVID M. BLIESNER, Ph.D.,\u003c\/b\u003e is Founder and President of Delphi Analytical Services, Inc. He provides CGMP consulting and training services to the pharmaceutical, biopharmaceutical, contract analytical laboratory, and allied industries. He possesses a unique combination of science and business skills and experience. These skills and experiences range from analytical R\u0026amp;D in the pharmaceutical industry to business plan preparation and market analysis in the chromatography supplies and contract analytical and instrument services businesses. Dr. Bliesner' s expertise includes quality assurance auditing of GMP laboratories, developing and implementing corrective action plans for analytical laboratories with compliance challenges, high performance liquid chromatography, experimental protocol design and project management. He has been part of the \"Expert Consultant\" contingent for five companies operating under consent decree with the FDA where he has helped with the establishment of GMP compliant laboratory control systems.   \u003c\/p\u003e\u003cp\u003e\u003cb\u003eDevelop an understanding of FDA and global regulatory agency requirements for Laboratory Control System (LCS) operations\u003c\/b\u003e \u003c\/p\u003e\u003cp\u003eIn \u003ci\u003eLaboratory Control System Operations in a GMP Environment\u003c\/i\u003e, readers are given the guidance they need to implement a CGMP compliant Laboratory Control System (LCS) that fits within Global Regulatory guidelines. Using the Quality Systems Approach, regulatory agencies like the FDA and the European Medicine Agency have developed a scheme of systems for auditing pharmaceutical manufacturing facilities which includes evaluating the LCS. In this guide, readers learn the fundamental rules for operating a CGMP compliant Laboratory Control System. \u003c\/p\u003e\u003cp\u003eDesigned to help leaders meet regulatory standards and operate more efficiently, the text includes chapters that cover Laboratory Equipment, Laboratory Facilities, Method Validation and Method Transfer, Laboratory Computer Systems, Laboratory Investigations as well as Data Governance and Data Integrity. The text also includes chapters related to Laboratory Managerial and Administrative Systems, Laboratory Documentation Practices and Standard Operating Procedures and General Laboratory Compliance Practices. Additionally, a chapter outlining Stability Program operations is included in the text. \u003c\/p\u003e\u003cp\u003eIn addition to these topics, it includes LCS information and tools such as: \u003c\/p\u003e\u003cul\u003e \u003cli\u003eEnd of chapter templates, checklists, and LCS guidance to help you follow the required standards\u003c\/li\u003e \u003cli\u003eElectronic versions of each tool so users can use them outside of the text\u003c\/li\u003e \u003cli\u003eAn In-depth understanding of what is required by the FDA and other globally significant regulatory authorities for GMP compliant systems\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eFor quality assurance professionals working within the pharmaceutical or biopharma industries, this text provides the insight and tools necessary to implement government-defined regulations.\u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47989504573669,"sku":"NP9781119529231","price":161.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9781119529231.jpg?v=1761784370","url":"https:\/\/k12savings.com\/es\/products\/laboratory-control-system-operations-in-a-gmp-environment-isbn-9781119529231","provider":"K12savings","version":"1.0","type":"link"}