Any company working in a CGMP (Current Good Manufacturing Practices), CGLP (Current Good Laboratory Practices), or CGCP (Current Good Clinical Practices) setting is required to follow CGDP (Current Good Documentation Practices) per 21 CFR Part 211.
FDA audits start with examination of documents and many of the FDA’s observations and citations relate to documentation issues. This package will help your company to ensure that all employees are aware of CGDP and know how to follow them.
This product addresses the following key concepts:
- CGDP Basics and Principles
- Quality Attributes
- Guidelines for Correcting Errors
- Electronic Records
- Responsibility of CGDP
- Training Quiz (.pdf, 2 pages)
- Editable Training Quiz (.docx, 2 pages)
- Training Quiz Answer Key (.pdf, 2 pages)
- Editable Training Quiz Answer Key (.docx, 2 pages)
- Training presentation (.pdf, 41 slides)
- Editable Training Presentation (.pptx, 41 slides)
- Training Attendance Sheet (.pdf, 1 page)
- Editable Training Attendance Sheet (.docx, 1 page)
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