Description
In this course, you will learn about Good Documentation Practices, including the ALCOA-C principles, notes to file, and other general documentation procedures. Good Documentation Practices are necessary to ensure product quality and product safety.
This course includes the following resources:
1. ALCOA-C Exercises Workbook
2. Why Good Documentation Practices Handout
3. Six Key Elements of Quality Data Handout
4. Investigator Warning Letter
5. Sponsor Warning Letter
6. NTF Warning Letter
This course can be used alone or as part of the full curriculum.
