PDA Letter Article

Amgen Team Brings Expertise to Taiwan Chapter

by Yi-Yin Lu, Secretary General of PDA Taiwan Chapter


The importance of quality culture has been increasingly recognized across the industry as it has a strong influence on product quality. In fact, regulators have been paying more attention to it recently due to an uptick in data integrity issues observed within the industry. In addition to quality culture, knowledge management is crucial. ICH Q10: Pharmaceutical Quality System identifies knowledge management as one of the enablers to implementing an effective pharmaceutical quality system.

(l-r) Ivy Chen; Jung-Jung Hsia; Chi-Wen Hsieh; Mark DiMartino; Dan Weese; Cylia Chen-Ooi; Brian McBreen; John Lin