iSpeak Blog
The future landscape of biomanufacturing is changing at the most rapid pace in decades, so the biopharmaceutical professional of today must be prepared for what's new on the horizon in facilities and equipment, production, and process technology in order...
iSpeak Blog
In this evolving world of bioproducts and novel manufacturing approaches, consideration for the upcoming challenges in process validation requires innovation and collaboration among our collective industry leaders and our regulatory agencies. The...
iSpeak Blog
In today's pharmaceutical industry, process validation relies on information and knowledge from product development activities to ensure patient requirements are translated into product attributes. A key to success is establishing a comprehensive...
iSpeak Blog
Featured in this edition of iSpeak Reading Roundup are the top blog posts from April 2019. See key industry topics, membership experiences, and more for what the pharmaceutical industry was reading last month. 2019 Pharma Best Practices –...
iSpeak Blog
A derivative of a trendy if not overused moniker, used by many other industries to convey a new start, a new future, and substantial change from the past. Is biopharma manufacturing really at such a juncture? The committee members organizing ISPE’s 4th...
iSpeak Blog
In pharma, as with the rest of the industries, the 4.0 concepts are not precisely new, yet the new scenario opens a brand-new perspective: everybody is involved, with new technologies, and new, pervasive information. This means increasing patient demand...
iSpeak Blog
Janette Buechler Sales & Marketing Communications Manager Pharmatech Associates What brought you to ISPE, and what are the various volunteer roles you have...
iSpeak Blog
Lessons Over Coffee Mentorship is a key component in career growth that can be found in unexpected ways. Cultivating a range of mentors who offer unique lessons learned and insightful advice that can differentiate your career perspective. A year ago, I...
iSpeak Blog
At the Women in Pharma® breakfast panel discussion on Powerful Leadership held at the ISPE Facility of the Future Conference, 7 - 8 February in San Francisco, California, five speakers offered perspectives on leadership and team building. The information...
iSpeak Blog
ICH Q12 is another quasi-management-based regulatory guideline.1 In a nutshell, the industry should expect additional confusion and more work from a vaguely defined, potentially duplicative system that will likely further inhibit the industry from...
iSpeak Blog
Global Day of the Engineer, taking place 3 April 2019, is a day to celebrate engineers and all they do to advance the pharmaceutical industry, while also engaging students to inspire the next generation of engineers to help them learn about the impact,...