Good Laboratory Practices (GLP) Training
Proper understanding of and compliance with GLPs is essential to provide credible preclinical data to regulatory authorities. 21 CFR Part 58 refers to a quality system of management controls for analytical and bioanalytical laboratories or animal testing facilities.
This course can be customized to meet your company’s specific needs. We can create customized program content for new employees, experienced personnel who need refresher training, or specialized groups such as monitors, regulatory staff, QA, etc.
You can select from our listed topics or we can incorporate other relevant topics that you request.
Examples of 483s, Warning Letters or other official action will be included, as appropriate.
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Suggested GLP Topics
- GLPs: a brief overview
- Why do we need GLPs?
- The differences between GLP and GMP
- GLPs for nonclinical laboratory studies
- Facility disqualification
- Documentation:
- Good documentation practices
- SOPs: authoring, approving, revising and training
- Change Control
- Responsibilities of Management, Study Director and QA
- Facility Requirements
- Equipment Requirements
- Equipment qualification and calibration
- Preventive maintenance for equipment and facilities
- Analytical method “validation”
- IACUC and Animal Care
- Test and Control Articles
- Test article preparation
- Avoiding mix-ups and contamination
- Protocol and Study implementation
- Auditing for compliance and effects of GLP non-compliance
- Qualifying GLP contractors
- Establishing effective CAPA programs to resolve audit observations at contractors
- Reports, Records, Archiving
- Frequent GLP Inspectional Findings