- Implementation of Good Laboratory Practice (GLP)
- Good Laboratory Practice training
- Gap analysis & Implementation plan
- Standard Operating Procedures (SOPs)
- Work Instructions (WI)
- Facility, process & study inspections
- Preparation of Audit agenda, checklist, report
- Visit on site, Interviews, Document review, Closing meeting
- Corrective Action / Preventive Action (CAPA)
- Quality Assurance (QA)
- QA inspection of study plan, study phases & report
- QA audits of external sites, vendor evaluation
- QA support in validation …
- Test facility/ Site
- Quality program
- Study preparation
- Study plan
- Verify study plan, amendments
- Study results
- Study report
