Partner, pathfinder, and facilitator for all your document development needs
Planning and Writing High-Quality Investigation Reports for Regulatory Compliance
Learn How to Write Effective and Accurate Reports that Comply with FDA Regulations
This one-day workshop for development and manufacturing specialists clarifies the scope of relevant FDA guidance for failure investigations and teaches essential skills necessary to ensure compliant, high-quality documentation. Participants will improve their documentation skills through writing exercises and analysis of sample reports. After this workshop, participants will be able to:
· Structure an effective and traceable summary report
· Recognize elements of good technical writing
· Improve the capture and documentation of facts and root causes
· Document the investigation process in the most accurate manner
· Ensure corrective action is appropriately described
The customized curriculum uses documents drawn from your organization and real-life case studies. The curriculum devotes 40% of time to lecture, 20% to discussion, and 40% to individual and group exercises.
For additional details about this workshop, including the workshop outline, please download an information sheet.