Data Integrity: The Roadmap to Compliance
MWA is offering a new, comprehensive training program on Data Integrity, available for onsite presentation at your company. Data integrity is critical for ensuring safety, efficacy, and quality of drugs and the quality of data produced during clinical trials and as part of the Application Integrity Process (AIP).
This interactive workshop, which can be customized to meet your needs and schedule, will include the following topics:
- Key Terms and Concepts
- Regulatory Requirements and Considerations
- Training and Self Audits
- The Roadmap to Compliance: Management Governance, Culture, Risk Assessments, Data Governance, Technology and Validation, Procedures and Processes, FDA Warning Letters, ALCOA+