This webinar on Good Documentation Practices will review the FDA requirements for documenting data in preclinical and clinical studies and manufacturing activities.
Why Should You Attend:
The FDA continues to cite documentation errors and omissions as one of its main findings during investigations. These errors take either of two forms:- Continual and repeated 'small' documentation errors.
- Critical documentation errors that affect the integrity of the study or batch records.
- This presentation will review the requirements for documenting data in preclinical and clinical studies and manufacturing activities. It additionally covers the principle of data chain-of-custody. The presentation also covers traceability of samples, specimens, retains, discards, and archived materials.
Areas Covered in the Seminar:
- The documentation practices that enhance study integrity, repeatability.
- How to prevent 483 items related to data documentation.
- The main documentation errors seen and cited by the FDA.
- Why GLP serves as a good foundation for clinical studies, GMP, and even research.
- Tips for documentation in lab notebooks.
- Tips for documentation in synthesis research and feasibility studies not regulated by GLP.
- A test for confirming documentation is complete and accurate.
- A brief historical review of poor documentatiuon in the past before the advent of GMP and GLP.
Who Will Benefit:
This webinar is for the data-collecting and report-writing participants in all regulated companies:- Study directors
- Management at sponsor companies
- Principal investigators
- Laboratory staff and analysts
- Contract laboratories
Course Provider
Anne E Maczulak,
