Articles

Pharmaceutical Engineering is introducing a new part of the Pharmaceutical Engineering Online site: Online Exclusives. This content will be published only to the ISPE web site—it will not be published in print. Read on for FAQs about this new feature,...

Featured in this edition of iSpeak Reading Roundup, are the top blog posts from February 2020. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last...

As we continue to monitor the COVID-19 pandemic, our thoughts are with our Members and those impacted. We recognize that the ever-changing impact of this novel virus is disruptive to so many aspects of our personal and professional lives. We are not...

One predominant and common element within our pharmaceutical industry, is our devotions to patients. Within supply chain there is always a focus on ensuring the right product is delivered to the right place at the right time in order to ensure patient...

ISPE places the health and safety of its members, staff, and the broader ISPE global community as its top priority. As the COVID-19 outbreak continues, the ISPE Drug Shortages Initiatives Team encourages everyone to follow the available safety and health...

ISPE 2020 Aseptic Conference - Day 1 The 2020 ISPE Aseptic Conference kicked off on schedule Monday 2 March with a full complement of programs, speakers, and more than 200 attendees, despite the spread of COVID-19 around the world. It was business as...

The biopharma industry is changing at a fast speed in response to the real pressures that it currently faces for producing an increasing number of complex therapeutic molecules, faster, with consistent high quality, and cost-effective manufacturing...

The pharmaceutical industry’s work on developing treatments and vaccines for COVID-19 (novel coronavirus) is moving forward, including these recent developments: Gilead’s remdesivir treatment is in clinical trial in China, and the company announced it...

It’s hard to believe, but it was 10 years ago when I gave my first presentation on continuous manufacturing for pharmaceuticals. It was at the ISPE Nordic Conference in Copenhagen in 2010, and I was still at FDA at the time. Looking back, it’s...

Wendy T. Haines, PhD, DABT, CQA Associate Director of Technical and Scientific Services PharmEng Technology I grew up in the 1970s watching my dad, who...

In April 2010, the Eyjafjallajökull volcano in Iceland erupted for six days, wreaking havoc on air travel and supply chain activities across western and northern Europe for a month. Many companies were caught off guard, resulting in industry-wide...

The 2020 ISPE Aseptic Conference starts in one week! Here's all the info you need to make the most of your experience. Conference Essentials Conference AgendaTravel Information Registration and Information Hours Sunday, 1 March | 1300–1700 Monday, 2...

If you work in the parenteral manufacturing space, it’s a foregone conclusion that you can pinpoint the emotion and anxiety that comes from receiving word that the FDA has arrived at your facility for an inspection. If Billy Joel were to pen the lyrics...

The theme of “Proactive Career Design” for the Women in Pharma® (WIP) Breakfast Session at the 2020 ISPE Facilities of the Future conference on 31 January in San Francisco was a fitting one: design and implementation apply equally well to careers as to...

Featured in this edition of iSpeak Reading Roundup, are the top blog posts from January 2020. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last...

“I’ve never received such useful advice about my career before. I came to the event last year but I still learned so many new ideas and tips this year,” says Megha Shah, a Chemical Engineering Student from UMass Amherst. Megha was one of the many...

Deborah A. Geyman Deborah Geyman became interested in pharma while still in high school; today, after working in the industry for three decades, she is...

Biopharmaceutical manufacturing faces many new opportunities as we enter this decade. ISPE is returning to Boston for the 2020 ISPE Biopharmaceutical Manufacturing Conference on 1-3 June 2020, bringing you once again an innovative conference, followed by...

In the previous blog, GAMP® Support for Pragramtic Quality & Risk-Based Approaches, we saw how as part of the Case for Quality program US FDA CDRH (Center for Devices and Radiological Health) are promoting a risk-based, product quality and...

I have been going to the ISPE Aseptic Conference since 2008 and the overwhelming response is that this is the best technical conference that ISPE hosts. The amount of learning, networking, and understanding that you can get at this conference is...

“The grass is not always greener.” Have you ever been told that before? When I went to my long time mentor 13 years ago to let her know that I was resigning from our company those were the words she spoke to me. I took her words to heart, but still felt...