ISPE’s official blog, iSpeak accepts contributions from our Members and professionals in the pharma industry.
FDA’s efforts to continue streamlining approval pathways for medical devices was expanded when, on September 20, 2019, the Agency issued new Final Guidance as a means to help manufacturers understand how the Agency will determine substantial equivalence for considerations of the review of...
Zen-Zen Yen is a highly active Young Professional in the ISPE D/A/CH Affiliate who also is engaged in the Affiliate’s Women in Pharma® initiatives and...
Pfizer Inc. is the 2019 ISPE Facility of the Year Category Winner for Project Execution for their Pfizer Global Technology Center in Hangzhou, China.
Eli Lilly and Company is the 2019 ISPE Facility of the Year Category Winner for Process Innovation for their IE2 Small Volume Continuous Facility located in Kinsale, County Cork, Ireland.
Edwin Harmon, Vice President of Engineering, Facilities, and Validation with LSNE and active member of the ISPE Boston Area Chapter (Board Member), is reaching his 30th anniversary as an ISPE Member. We talked with Edwin to find out about some of his experiences and discover what he has learned over three decades with the Society.
