iSpeak Blog

August 03, 2017
Participants gathered for the Women in Pharma breakfast on day 2 of the 2017 ISPE/FDA/PQRI Quality Manufacturing Conference , held 5 – 7 June 2017. Women in Pharma chair, Fran Zipp, CEO and President, Lachman Consultants and ISPE Board Member, welcom...
August 02, 2017
With the Brexit referendum resulting in the United Kingdom (UK)’s decision to leave the European Union (EU), the European Medicines Agency (EMA), currently located at Canary Wharf in London, will need to find a new home. At an EU Summit in Brussels 2...
July 31, 2017
This article presents a consensus standardized extractables testing protocol for single-use systems in biomanufacturing This article was originally published in the November – December 2014 issue of Pharmaceutical Engineering® magazine . Click here f...
July 27, 2017
The ISPE Process Validation Statistics Conference has become a converging point for statisticians and those skilled in the use of statistics to reflect on past practices, describe current trends, and explore future challenges. The conference serves a...
July 26, 2017
The 2017 ISPE Annual Meeting & Expo kicks off on 29 October thru 1 November 2017, in San Diego, California. This must-attend event features content-rich sessions with industry experts, delivering practical solutions to your daily challenges. If you a...
July 25, 2017
As Chair of the 2017 ISPE Process Validation Conference , I am pleased to invite you to join us in Bethesda, Maryland, 12 – 14 September to expand your knowledge of the lifecycle approach to process validation. In addition to case studies and lessons...
July 24, 2017
This article presents a consensus standardized extractables testing protocol for single-use systems in biomanufacturing This article was originally published in the November – December 2014 issue of Pharmaceutical Engineering® magazine . Click here f...
July 20, 2017
As Co-Chairs of the 2017 ISPE Process Validation Statistics Conference , we are pleased to invite you to join us in Bethesda, Maryland, 13 – 15 September as we explore evolving and state-of-the-art approaches to implementing statistics in process val...
July 18, 2017
This article presents a consensus standardized extractables testing protocol for single-use systems in biomanufacturing This article was originally published in the November – December 2014 issue of Pharmaceutical Engineering® magazine . Click here f...
July 14, 2017
Mihaela Simianu, PhD, Director of Regulatory Compliance, Pharmatech Associates, Inc., led an interactive session on Emerging Therapeutic Entities in Immunotherapy and Gene- and Cell-Based Therapies on 6 June 2017, day 2 of the 2017 ISPE/FDA/PQRI Qual...