iSpeak Blog

Over the past decade, companies worldwide have faced increased scrutiny from consumers, investors, and regulators over how they treat the environment. They are questioned about where and how they source raw materials, the packaging they use, power consumption levels, and waste generated. Many companies understand these concerns and have taken active steps to be sustainable. Building industry...

This instructor led course is an advanced level course on Chemistry, Manufacturing and Controls (CMC) aspects of biopharmaceutical development. The purpose of this course is to provide an advanced understanding of the CMC considerations of biopharmaceuticals from development to commercialization. An....
This instructor led course introduces participants to the process of developing biopharmaceuticals starting with the gene of interest and ending with a commercial product. The course will cover process development, formulation, cell banking, manufacturing of drug substance, drug product and....
Media & Press Releases
21 January 2022
ISPE announced the release of the ISPE Good Practice Guide: Controlled Temperature Chambers – Commissioning and Qualification, Mapping and Monitoring (Second Edition) . This Guide was written to meet changing industry practices, as global...
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Historically, industrial manufacturing has advanced from mechanization to mass production and then to automation/computerization. The next phase of manufacturing (referred to as Industry 4.0) involves the integration of...
iSpeak Blog

Featured in this edition of iSpeak Reading Roundup, are the top blog posts from December 2021. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.

20 January 2022 - 20 January 2022
Join us for a fantastic Women in Pharma event! RMISPE Women in Pharma Virtual Panel, "Advocating for Yourself"! Speakers: Julianne Fantich, Controls Engineer, Wunderlich-Malec Kristen Pyle, Vice President, Cumming Management Group Sally Rush...
iSpeak Blog

I’m from the past, but to some degree, we all are.

A number of years ago, I received my Bachelor’s degree in mechanical engineering and a desire to make the world a better place. I joined the pharmaceutical industry with that goal in mind. 30 years later, I have that same desire, but the industry looks significantly different.

25 January 2022 - 25 January 2022
Project Debrief: Integrated C&Q Applied On a Turn-Key Project Format: GoToWebinar Instructions to join will be emailed one day prior Moderator: Justin Cantor, Chief Strategy Officer, PSC Biotech Speakers: James Golden PE, Project Design Lead (Process...
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