iSpeak

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...

Aseptic filling of parenterals is one the most challenging tasks within pharmaceutical manufacturing. There is a wide range of topics that fall under this umbrella, from more engineer-driven topics like filling accuracy and machine performance to key...

The 2020 ISPE Facilities of the Future Conference Thursday! Here's all the info you need to make the most of your experience. Conference Essentials Conference AgendaTravel Information Registration and Information Hours Thursday, 30 January 2020 |...

One of the most popular travel destinations for famous movie sites and excellent culinary options, San Francisco will host the 2020 ISPE Facilities of the Future conference. During your free time at this year’s conference, explore creative pieces of...

Each year many people start off with how they are going to be better than the year before and write down unrealistic goals about their professional and personal time next the 365 days. Our team at Women in Pharma® has sat down and put together a...

Featured in this edition of iSpeak Reading Roundup, are the top blog posts from December 2019. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last...

Since April 2017, the European Pharmacopeia allows to produce Water for Injection (WFI) using other methods than distillation. Meanwhile, the additional water quality "Highly Purified Water" (HPW) could be found in the Ph. Eur. but will be removed in...

Featured in this edition of iSpeak Reading Roundup are the top 10 blog posts from iSpeak in 2019. Gain key insights on FDA process validation guidelines, Pharma 4.0 developments, and more on what the pharmaceutical industry has explored and accomplished...

2019 was a very busy year for ISPE Communities of Practice (CoP). Our biggest project was the launch of ISPE’s new community platform – Community Connection. This new online platform provides members with a more robust and user-friendly experience,...

The pharmaceutical industry has made 2019 a remarkable year for innovation in science, technology, and most importantly, patient health. This year the industry has overcome challenges in sterile manufacturing, complex technologies, and the increasing...

On Wednesday, 4 December 2019, ISPE held its first-ever Executive Forum focused on Workforce of the Future issues impacting the pharmaceutical industry.  The Forum was an important milestone in the broader Workforce of the Future initiative being led by...

Featured in this edition of iSpeak Reading Roundup are the top 10 articles from the 2019 issues of Pharmaceutical Engineering® magazine. Discover key insights for data integrity, manufacturing excellence, innovative validation practices, and more for...

Featured in this edition of iSpeak Reading Roundup, are the top blog posts from November 2019. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last...

The formal announcement and certification of the ISPE Mexico Affiliate took place at the recent 2019 ISPE Annual Meeting & Expo in Las Vegas, Nevada on Tuesday, October 29. The creation of the ISPE Mexico Affiliate was promoted by a group of enthusiastic...

Recap of the Opening Plenary Session of the 2019 ISPE Global Pharmaceutical Regulatory Summit Industry and regulators came together on 5-6 December for the 2019 ISPE Global Pharmaceutical Regulatory Summit in North Bethesda, Md. Regulators were both...

The inaugural Global ISPE Student & Young Professionals’ Hackathon at 2019 ISPE Annual Meeting & Expo brought together 36 students and Young Professionals from around the world to compete in a team-oriented, highly educational workshop. The Hackathon...