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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...

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...

As many recent pharmaceutical product quality problems have shown, current Good Manufacturing Practices (GMPs) as defined by regulatory guidelines and current best practices may not be “good enough” in the 21st Century. 1, 2, 3  Although, much of the...

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 –...

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...

In recent years, continuous manufacturing (CM) has gained a considerable amount of attention in the pharmaceutical industry. Although relatively new to pharma, it is widely applied in other industries where automated production techniques drive faster...

On 30-31 March 2019, the 2019 ISPE Europe Annual Conference held its third Young Professional Hackathon title “Young Professional Gathering”. More than 30 ISPE Young Professionals (YPs) came from all over Europe to participate in this two-day event that...

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...

Janette Buechler Sales & Marketing Communications Manager Pharmatech Associates What brought you to ISPE, and what are the various volunteer roles you have...

Tremendous advances in aseptic processing technology have been made and many operations have been modernized, said Richard Friedman, Deputy Director, Science and Regulatory Policy, Office of Manufacturing Quality, FDA/Center for Drug Evaluation and...

Frances M. Zipp President & CEO Lachman Consultant Services, Inc Chair of the Nominations Committee and the ISPE Board of Directors Vice Chair In 2013, I...

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...

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...

In too many cases, the Spare Parts Storeroom has become the unavoidable appendage to the functioning of the Maintenance and Facilities Departments. The importance and support it should receive constantly fail to reach acceptable levels. In many other...

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...

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,...

The 2019 ISPE Europe Annual Conference kicked off with the Executive Forum on Monday, 1 April 2019. Check out the slideshow of highlights from day one below.

ISPE is excited to announce a complimentary webinar series, featuring leading subject matter experts covering critical topics in pharmaceutical manufacturing. Thought leaders will share their insights during a 45-minute presentation and then you’ll have...