iSpeak Blog
A deeper understanding of HVAC and environmental control is essential to ensure the quality and purity of a product. HVAC systems are crucial to pharmaceutical manufacturing because they control the manufacturing environment, which can impact the...
iSpeak Blog
Technology is not new. Biotechnology is not new; it’s new-ish. Yet when the two come together to look at how they can transform medicine, its creation, delivery, and access, well, that is new and can be extraordinary. Extraordinary enough that the FDA...
iSpeak Blog
It’s time for another edition of Reading Roundup featuring the top blog posts of July 2017. Start off your week by catching up on what the pharmaceutical industry was reading in July. Standardized Extractables Testing Protocol for Single-Use Systems...
iSpeak Blog
Rosario B. Barangan, RPh, MS Vice President E.L. Laboratories, Inc. What attracted you to pharmaceutical engineering? My family has been in the...
iSpeak Blog
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, welcomed...
iSpeak Blog
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 22...
iSpeak Blog
  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...
iSpeak Blog
    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...