Press Release / Nov 22, 2021
Hovione announces New Pharma Campus expansion in New Jersey
This expansion in New Jersey will create up to 100 jobs over the next few years is part of a global expansion strategy
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