Tagged: FDA

LIVE FROM PDA/FDA: Compliance to Quality: Part 1

This article does not discuss cold chain specifically, however the discussion about the Center for Drug Evaluation and Research (CDER), the Office of Pharmaceutical Quality (OPQ), and...

Ensuring Supply Chain Safety

This article discusses security and data integrity in the Supply Chain, with a focus on suppliers (domestic and foreign).  The article does not center around...

Applying GDP to Biologics

Mary Foster, Pharm.D, USP Chair – PSD Expert Committee 2015-2020, presented a workshop on the applications of Good Distribution Practices to biologic shipping at the...