From Change Request to Change Implementation
During a product’s lifecycle, many changes might occur in the production, labeling (usage) and quality of the drug. For every change the impact on quality, safety and efficacy needs to be evaluated. This requires a change control process. Change control processes are complex and require standards and systems for tracking and tracing changes in development and applied. This presentation is to clarify dependencies and how it can be facilitated by proper functionality of tools.
- Multi-disciplinary activities
- Transparency and conformity
- Process standards and semantics
Speaker: Hans van Bruggen, Senior Regulatory Affairs Scientist - eCTDconsultancy B.V. The Netherlands on behalf of Amplexor Life Sciences