Following FDA Guidance: Continuous Improvement in an Outsourced Environment

Many organizations face growing needs to outsource operations to contract manufacturing organizations (CMOs). Meanwhile, the FDA continues to enact new guidelines and regulations impacting contract manufacturing agreements. Although the new guidelines are intended to stimulate increased collaboration between sponsors and CMOs, the problem is that organizations don’t feel like they have clear direction as to how they need to update their operations.

Co-authored by Shire and BIOVIA, this art ...

Last Published: September 2, 2014 by Julie

Category: Life Sciences