Duration 3 Days

Course Outlines:

1. Principles Good Laboratory Practice:
   • Study Director and Principal Investigator.
   • Test Facility and Test Site.
   • The Study.
   • Short-Term Studies.
   • Initiation, Starting and Completion Dates.
   • Study Plan, Amendments and Deviations.
   • Raw Data.
   • The Phases of a Study.
   • The Master Schedule.
   • Test and Reference Item.
   • Additional Definitions.

2. Responsibilities in Good Laboratory Practice:
   • Study Director and Principal Investigator.
   • Study Personnel.
   • The Sponsor.

3. The Quality Assurance Programme:
   • General Considerations.
   • Quality Assurance Inspections.
   • Quality Assurance Inspection Reports.
   • Audits of Raw Data and of Final Reports.
   • The Quality Assurance Statement.

4. Facilities:
   • General Requirements.
   • Test System Facilities.
   • Facilities for Handling Test and Reference Items.
   • Archive Facilities.

5. Apparatus, Materials and Reagents:

6. Computerized Systems:
   • Basic Considerations.
   • Data considerations.
   • Prospective Validation.
   • Retrospective Evaluation.
   • Maintenance and Change Control.
   • Levels of Complexity.

7. Test Systems:
   • Physical/Chemical Test Systems.
   • Biological Test Systems.

8. Test and Reference Items:
   • Handling and Documentation.
   • Expiry Dates.
   • Sample Retention.

9. Standard Operating Procedures:
   • The Format.
   • Issue, Approval and Distribution.
   • On-line SOPs.
   • The Content.
   • Where are SOPs required?

10. Study Performance and Reporting:
    • The Study Plan.
    • Study Conduct.
    • The Final Report.
    • Re-opening and Amending a Study.
    • Discontinued Studies.

11. ISO 17025 Introduction to Accreditation

12. Typical Case Studies