Gaining the experience to achieve data compliance can be a long and expensive process. However, a faster and quicker option is to learn from others’ mistakes. For a regulated good manufacturing practice (GMP) laboratory, a great way to achieve this is to use US Food and Drug Administration (FDA) warning letters. In this guide, we will use warning letters to highlight non-compliances and discuss various solutions to these problems.
Download this guide to learn how to avoid remediations for citations such as:
- Loss of electronic records
- Uncontrolled and unvalidated spreadsheets
Conflict of interest