Abstract
PDA has identified eleven current questions related to data management and control that have been frequently cited in FDA Inspections or have led to FDA regulatory actions. The purpose of this document is to help to clarify some of these issues for industry and to help facilitate better compliance by sharing PDA members' expertise in and understanding of current best practices.
- Received January 15, 2018.
- Accepted January 21, 2018.
- Copyright © 2018, Parenteral Drug Association