Are you responsible for preserving documents or for ensuring that your company’s data is complete and correct?

Stay on top of your field by learning the regulatory requirements and best practices for pharmaceutical documents, documentation, and record keeping.

In this course, we review the differences between documents and records, and we talk about the typical ISO 9001 document hierarchy. We also explain each document level. Participants study record keeping requirements, including the electronic signature and and other regulations in 21 CFR Part 11. Plus, we answer questions about the appropriateness and qualification of Excel spreadsheets for record keeping.

Finally, we review general good documentation practices incorporating the requirements in FDA’s Guidance to Industry “Data Integrity and Compliance with CGMP.”