This session will attempt to link regulatory and scientific aspects related to pharmaceutical quality issues occuring in manufacturing. A regulatory update will be provided on recent compliance actions related to product recalls and drug shortages. Industry speakers will follow, discussing how scientific understanding and manufacturing controls can help mitigate risks to product quality in the future.

Learning Objectives:
Discuss emerging issues related to drug product quality
Describe how science and risk based approaches can be used to both resolve known issues and to avoid potential future ones.