This program will teach you to set specifications for drug substance and drug product,including use of release test data, long term stability, accelerated stability and special stability studies. The webinar will also cover changing specifications during lifecycle management.
Learn the recommendations of ICH for using testing and stability data to set specifications for drug substances and drug products including use of special stability studies. Learn requirements for changing specifications through the lifestyle of the product.
- Setting initial specifications
- How to use available data and justify specifications
- ICH specific recommendations will be discussed
- Information required to br submitted during the lifecycle
- Updating the specifications during developing and commercial phases
- Manufacturing Departments
- Supply Chain Departments
- Technical Operations Departments
- Quality Control Departments
- Quality Assurance Departments
- Regulatory Affairs Departments