About the course:
Good Laboratory Practice (GLP) course addresses good laboratory practice in the wide sense covering all the practices that ensure that laboratory testing is planned, performed, monitored, recorded and reported in an organized and controlled manner.
The course provides training in the principles of good laboratory practice for personnel of laboratories who wish to produce test results that are fit for the purpose and which would stand up to the scrutiny of, for example, Good Laboratory Practice Compliance Inspectors / FDA or IMB Inspectors.
The course addresses the requirements of EN ISO / IEC 17025: 2005 General Requirements for the Competence of Testing and Calibration Laboratories as well as the common requirements of GLP Compliance (OECD & FDA) as applicable to QC/QA/Production Control Laboratories.
Who should attend:
The course is designed to pharmaceutical and other production’s quality control and assurance personnel, for R&D laboratories, universities.
Certificates of completion are given to course participants upon successful graduation.
Course program:
The course covers following topics:
- Drug Design,
- Introduction and Fundamentals of GLP,
- All You (Never) Wanted to Know About GLP and GMP,
- “International” GLP of the OECD,
- Management, Personnel, Buildings & Equipment,
- Characterization (Part 1 – Test item),
- Characterization (Part 2 – Test systems),
- Management – Roles & Responsibilities,
- Study Director – Role & Responsibilities,
- RULES (Protocol or Study Plan; Standart Operating Proceducers (SOP)),
- RESULTS,
- Method Validation (Analytical method validation; Bio-analytical method validation),
- QUALITY ASSURANCE.
Course Manual:
The course comes with a comprehensive manual, which proves to be an excellent handout and source of reference after the course.