Good Clinical, Laboratory and Manufacturing Practices
Techniques for the Qa Professional
Herausgeber: Carson, Philip; Dent, Nigel
Good Clinical, Laboratory and Manufacturing Practices
Techniques for the Qa Professional
Herausgeber: Carson, Philip; Dent, Nigel
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Written by a team of world experts, the book provides practical and detailed advice for the quality assurance professional responsible for monitoring compliance with legal requirements and accepted standards of pre-clinical safety studies, clinical trials and manufacture of drugs. It provides a framework for integrating these standards with other quality management systems. Detailed examples are provided to illustrate application of the principles. The book is targeted primarily at all those subjected to internal and external inspection and audit for compliance with the requirements of good…mehr
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- Produktdetails
- Verlag: RSC Publishing
- Seitenzahl: 656
- Erscheinungstermin: 1. Juni 2007
- Englisch
- Abmessung: 244mm x 191mm x 41mm
- Gewicht: 1406g
- ISBN-13: 9780854048342
- ISBN-10: 0854048340
- Artikelnr.: 22950748
- Verlag: RSC Publishing
- Seitenzahl: 656
- Erscheinungstermin: 1. Juni 2007
- Englisch
- Abmessung: 244mm x 191mm x 41mm
- Gewicht: 1406g
- ISBN-13: 9780854048342
- ISBN-10: 0854048340
- Artikelnr.: 22950748
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
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