This GLP (Good Laboratory Practices) webinar reviews the process of closing a study by preparing a final report and managing all records and specimens in a proper manner. The GLP final study report represents the last chance for a study team to present their results in a clear and compelling manner. The report may also be a place where difficulties can be explained so that the study provides meaningful and trustworthy information. This webinar reviews the process of closing a study by preparing a final report and managing all records and specimens in a proper manner. It provides two areas of concentration: (1) the best practices in final report writing and (2) the step-by-step process of closing studies.
Areas Covered in the seminar:
- A description of a GLP final study report.
- Reporting requirements.
- Problems the FDA always sees.
- The QC process.
- Closing a study, step-by-step.
- Study amendments.
- Proper chain of custody and archiving.
Who Will Benefit:
This webinar provides final report writing background to people new to FDA requirements in GLP studies or as a refresher for personnel that have experience in GLP. It describes key points in report writing that often go overlooked. It also describes the closeout process in terms of QA, study director, principal investigator, management, and sponsor responsibilities.- Test facility managementt
- Study directors
- Principal investigators
- Contract laboratories
- QA representatives
- Sponsor companies
Course Provider
Anne E Maczulak,
