Good Clinical, Laboratory and Manufacturing Practices

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