Hovione New Jersey welcomed a team of 8 FDA Reviewers for two days training in its facilities. The training was organized under the scope of a training program FDA has in place to provide insight on how does industry apply QbD (Quality by Design), how a facility looks like, which challenges industry faces during development phases up to registration/validation campaigns.
The 8 FDA members are reviewers of drug substance section as part of the applications for DMF, NDA and IND.
TRAINING TOPICS
- Introduction to Hovione and New Jersey site
- Hovione Quality System
- Hovione methodology for QbD and Risk Assessment Strategy
- QbD methodology: A Case Study
- Plant Tour
- Workshop on Risk Assessment