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 Chair of the Nominations Committee and the ISPE Board of Directors Vice Chair In 2013, I made the...

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. Previous Slide◀︎Next Slide▶︎ ...

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...

We are in a period of unprecedented change – some would even say disruption in the types of medicines and technologies adopted. This comes in an environment with ever increasing demands to...

Andria Thomas, AA Student Solano Community College Andria Thomas is an ISPE Student Member who established and presides over the Solano Community College...

As 2019 is well underway there are great opportunities ahead for the pharmaceutical industry as the FDA continues its long-anticipated efforts at streamlining cumbersome application processes which will enable manufacturers to move forward with an eye...

Conference Essentials Conference Agenda Travel Tips Registration and Information Hours Sunday, 17 March | 1300–1800 Monday, 18 March | 0730–1830 Tuesday, 19 March | 0700–1700 Exhibit Hall Hours Monday, 18 March | 1015–1815 Tuesday, 19 March |...

North Bethesda, Maryland is a popular travel spot for the ample shopping destinations, fine dining options, rich history, and proximity to our nation’s capital, Washington, D.C. The state of Maryland itself holds many hidden gems for outdoor activities,...

Two of the contributors for the ISPE Baseline Guide: Sterile Product Manufacturing Facilities, discuss the modern technologies and break down of regulatory guidelines that will greatly assist pharmaceutical professionals and their facility...

While there has been much discussion around the regulatory issues of Continuous Processes (CP), the most significant challenges are associated with managing the product development activities of building Continuous Manufacturing (CM) processes in the...

The impact on current mutual commerce and regulatory recognition between the UK and other EU countries was and is still unclear. Pharma cannot afford to wait and see what the impact is on the release and distribution of Clinical Trial Material from the...

It's been clear for several years that the FDA, as well as the Federal Trade Commission (FTC), are turning up the heat on homeopathic drug products. It culminated in December 2017 when the FDA published a draft guidance document for both FDA staff and...

Continued Process Verification (CPV), the 3rd Stage of the FDA process validation guidelines, represents the Ship of Theseus in bioprocessing: The bioprocess is validated and on the market, but it inevitably is subject to changes in supplies, raw...

We provide a complete toolkit for you to easily host a successful event The Women in Pharma® toolkit is ready to help you host an event for your ISPE affiliate or chapter. Incredible events with thought-provoking topics have already been hosted across...