Good Laboratory Practice (GLP) Auditor Course is concerned with the audit organizational process and conditions under which laboratory studies, tests or experiments are planned, performed, monitored, recorded and reported with the intent to promote the quality and validity of test data.
This course offers the ideal training opportunity for moving into the field of GLP auditing
GLP Auditor COURSE CONTENT:
Understanding GLP Principles
Test Facility Organization & Personnel
Quality Assurance Program
Facilities
Apparatus, Material and Reagents
Test Systems
Test Reference Substances
Standard Operating Procedures
Performance of the Study
Reporting of Study Results
Storage & Retention of Records & Materials
Preparation of GLP Implementation Plan
GLP Audit
Key Principles of GLP Auditing
Assurance framework
Types of audit
Internal control
The concept of independence
Conduct of a GLP Audit
GLP Audit strategy and audit plan
Fieldwork
Reviewing and communicating results
GLP Audit Report
GLP Auditing Standards
Auditing the Internal GLP Auditor
Internal and External Assessments
The role of the external GLP auditor
Action Planning
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