Good clinical, laboratory and manufacturing practices techniques for the QA professional /: techniques for the QA professional. (©2007)

• Record Type: Book
• Further Information: Note: Edited by P.A. Carson, N. Dent.
• Other Names: Carson, P. A (Phillip A.), 1944-; Dent, N. J (Nigel J.)
• Contents: Chapter 1: Introduction to Part 1 -- GCP-- Chapter 2: The Protocol, Case Report Form & Initial Documentation -- Quality Assurance Involvement & Common Problems-- Chapter 3: Standard Operating Procedures in the GCP Environment-- Chapter 4: Preparing for Regulatory Inspections of Company Pharmacovigilance Systems & Practices in the European Union & United States-- Chapter 5: Investigator, Sponsor & Contract Research Organisation Audits-- Chapter 6: Data Audits-- Chapter 7: Research Ethics Committees-- Chapter 8: GCP/GMP Interface, Investigational Product Accountability-- Chapter 9: Monitoring & Quality Control-- Chapter 10: Phase I Healthy Volunteer Studies-- Chapter 11: Clinical Laboratories-- Chapter 12: Introduction to Part 2 -- Good Laboratory Practice-- Chapter 13: Quality Assurance in GLP-- Chapter 14: The Master Schedule Index-- Chapter 15: Study Plans & Their Audits-- Chapter 16: SOPs for GLP Work-- Chapter 17: Inspections -- Procedural, Process & Facility-- Chapter 18: Report and Data Audits-- Chapter 19: Quality Assurance & Contract Research Organisations-- Chapter 20: Quality Assurance & Pharmacology-- Chapter 21: Application of GLP in Analytical Chemistry-- Chapter 22: GLP in Drug Metabolism & Pharmacokinetics-- Chapter 23: Issues of Quality in Pathology-- Chapter 24: GLP in Eco-toxicology and Field Studies-- Chapter 25: Animal Health-- Chapter 26: Introduction to Part 3 -- Good Manufacturing Practice-- Chapter 27: Standard Operating Procedures (Specific to GMP)-- Chapter 28: Release of Bulk & Filled Finished Product-- Chapter 29: Good Manufacturing Practice for Investigational Medicinal Products-- Chapter 30: Chemical Analysis-- Chapter 31: GMP for Sterile Products-- Chapter 32: Statistics for QA Auditors of GLP and GCP Studies-- Chapter 33: The Use of Statistics in Research Quality Assurance-- Chapter 34: Supplier Auditing (GMP)-- Chapter 35: Centralised Supplier Audits (GLP)-- Chapter 36: Document Control from Concept to Archiving-- Chapter 37: Computing & GXP's-- Chapter 38: QA Developing A Regulatory Compliance Training Strategy-- Chapter 39: Training & Staff Records for GXP-- Chapter 40: Integrating Quality Systems (GCP, GLP, GMP, ISO 9000, 14001, 18001 & 17025.
• Publisher Details: Cambridge : RSC
• Publication Date: 2007
• Copyright Date: 2007
• Extent: 1 online resource (xxxiv, 622 pages), illustrations
• Subjects: 506.85; SCIENCE / Research & Methodology; Laboratories -- Quality control; Quality assurance; SCIENCE -- General; Laboratories -- Quality control; Quality assurance; SCIENCE / Chemistry / Industrial & Technical; Scientific standards; Industrial applications of scientific research & technological innovation; Ebook; Electronic books
• Languages: English
• ISBNs: 9781847557728; 1847557724
• Related ISBNs: 9780854048342; 0854048340
• Notes: Note: Includes bibliographical references and index.; Note: Print version record.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.