Navitas webinar series on ICH E6 GCP compliance
1st webinar of the series: Impact of ICH E.6 addendum on Quality for Sponsors (or Quality by Design in Clinical development)
Hosted by Navitas Networks this webinar is presented by Andy Lawton, Consultant and Director of Risk Based Approach Ltd and Janet Fernihough, Senior Consultant at Navitas Life Sciences.
The webinar addresses the following:
- What is Quality by Design?
- Regulatory perspective
- Drivers for quality in the pharmaceutical industry
- What can we learn about Quality by design from the manufacturing industry?
- The importance of design, control and improve.
- Application at the project and trial level
- Applying Quality by Design learning in manufacturing to clinical trial management
- Risk assessments
- Quality tolerance limits
- Continuous process improvement