The International Society for Pharmaceutical Engineering - ISPE

The International Society for Pharmaceutical Engineering - ISPE ISPE is the global industry leader in connecting pharmaceutical knowledge.

Students and recent graduates: Registration is now open for the 2025 ISPE International Emerging Leader Hackathon, takin...
09/09/2025

Students and recent graduates: Registration is now open for the 2025 ISPE International Emerging Leader Hackathon, taking place 25–26 October in Charlotte, North Carolina, in conjunction with the 2025 ISPE Annual Meeting & Expo.

Sponsored by Genentech, the 2025 ISPE International Emerging Leader Hackathon is themed "Beyond the Vial: Define the future of pharmaceutical manufacturing to enable and supply patient-centric drug delivery solutions." Participants will work collaboratively in teams to address this real-world problem, acting as a consulting group, and pitching their proposed solutions to a panel of industry experts.

Don’t miss this opportunity to learn, connect, and expand your network.

Secure your free spot today: https://hubs.la/Q03HG3tZ0...

Want to enjoy the full benefits of attending the 2025 ISPE Annual Meeting & Expo? Students and recent graduates receive special pricing. Check the associated tabs here: https://hubs.la/Q03HG7R10...

We’re proud to celebrate CSL Behring as the 2025 ISPE Facility of the Year Awards (FOYA) Category Winner for Pharma 4.0™...
09/09/2025

We’re proud to celebrate CSL Behring as the 2025 ISPE Facility of the Year Awards (FOYA) Category Winner for Pharma 4.0™. Located in Broadmeadows, Victoria, Australia, CSL Behring’s Project Aurora Plasma Base Fractionation Facility is the largest of its kind in the CSL network and globally. This state-of-the-art facility has transformed CSL’s operations by aligning all Broadmeadows-manufactured products with the global platform and increasing capacity nine-fold to process over ten million liters of plasma annually. The facility plays a vital role in producing therapies for immunodeficiencies, neurological conditions, and other critical health needs around the world.

Project Aurora stands out for its advanced integration of robotics, automation, and digital technologies. From automated guided vehicles and robotic cleaning systems to a fully automated powder handling process and a sophisticated MES, every element has been designed to enhance efficiency, safety, and data accuracy. The implementation of a digital twin and real-time analytics has further strengthened operations, enabling scenario-based simulations and continuous improvement. CSL Behring’s holistic application of Pharma 4.0™ principles exemplifies the future of pharmaceutical manufacturing and has earned them this well-deserved recognition.

Read the full blog to learn more about CSL's innovations: https://hubs.la/Q03G63C30

Be there when the spotlight shines! Get your ticket to the 2025 ISPE FOYA Banquet and Awards Celebration and find out who the overall winner will be: https://hubs.la/Q03G658g0

Pharmaceutical Engineering® is proud to announce that “FDA’s 2011 Process Validation Guidance: 10 Years On” (September/O...
09/08/2025

Pharmaceutical Engineering® is proud to announce that “FDA’s 2011 Process Validation Guidance: 10 Years On” (September/October 2024) by the ISPE Process Validation Team has been named a finalist for the 2024 Roger F. Sherwood Article of the Year Award.

This article is a collection of individual and collective responses from team members who are practitioners and industry participants in this field, representing a cross-section of pharmaceutical organizations, locations, and roles from all parts of the world.

Read the full article here: https://hubs.la/Q03HnFHf0

Find out who will receive the 2024 award during the 2025 ISPE Annual Meeting & Expo, 26–29 October, in Charlotte, North Carolina: https://hubs.la/Q03HnxP30...

Act now, this offer won’t last! For a limited time, use code 25AM250 to get $250 off your in-person registration for the...
09/08/2025

Act now, this offer won’t last! For a limited time, use code 25AM250 to get $250 off your in-person registration for the 2025 ISPE Annual Meeting & Expo, happening October 26–29 in Charlotte, North Carolina, USA. Don’t miss your chance to save on the industry’s must-attend event!

Whether you attend in person or virtually, the ISPE Annual Meeting & Expo delivers exceptional value through cutting-edge technical content, powerful networking opportunities, and access to the innovations shaping the future of pharmaceutical science and manufacturing.

Save and register now: https://hubs.la/Q03HgY_Y0...

In case you missed it, ISPE has announced new certificate programs from ISPE Academy: Biopharmaceutical Essentials and G...
09/07/2025

In case you missed it, ISPE has announced new certificate programs from ISPE Academy: Biopharmaceutical Essentials and Good Engineering Practices. The news was covered by Powder & Bulk Solids, where they emphasize ISPE Academy’s role in advancing industry expertise, stating, "ISPE Academy helps pharmaceutical professionals develop and strengthen their knowledge and expertise."

Whether you're just starting out or looking to deepen your understanding of biopharmaceuticals and engineering best practices, ISPE Academy offers flexible, high-quality education to support your professional growth.

Learn more about ISPE Academy: https://bit.ly/3JHIErp...

Read the full article: https://bit.ly/3K5LFBI

ISPE Academy’s Good Engineering Practices certificate program is built for professionals in the pharmaceutical industry ...
09/06/2025

ISPE Academy’s Good Engineering Practices certificate program is built for professionals in the pharmaceutical industry who want to strengthen their engineering project management skills and deliver complex engineering projects that are both efficient and compliant.

This program is a great fit for:
- Engineers moving into leadership roles
- Project managers working with complex systems
- Professionals aiming to align their work with global best practices

If you're ready to take the lead and manage projects with confidence, check out the program at ISPE Academy: https://bit.ly/41DEsyS...

Did you know joining ISPE means gaining more than just access to resources?When you become a member, you join a global c...
09/05/2025

Did you know joining ISPE means gaining more than just access to resources?

When you become a member, you join a global community that’s actively shaping the future of pharmaceutical engineering and manufacturing.

ISPE members grow and connect through:
– The ISPE Volunteer Program
– Mentor ISPE
– Communities of Practice
– Local Chapter involvement
– Industry-focused task teams and committees

Your membership is more than a resource—it’s a pathway to impact.

Join or renew today and help shape the future of pharma: https://hubs.ly/Q03H9-FZ0

09/04/2025

The 2025 ISPE Annual Meeting & Expo is just around the corner, so don't miss out on joining us in Charlotte, North Carolina, USA on 26-29 October for our largest conference of the year!

This event is one you don't want to miss, but don't just take our word for it, hear from Vivian Santillan! Register now: https://bit.ly/47L08x5...

Looking to build or enhance your organization’s Quality Management System (QMS)? ISPE’s SOP Templates are designed to su...
09/03/2025

Looking to build or enhance your organization’s Quality Management System (QMS)? ISPE’s SOP Templates are designed to support the development, implementation, and maintenance of clear, consistent, and compliant quality processes.

Whether you're establishing a new QMS from the ground up or improving existing procedures, these templates provide a structured, audit-ready framework that aligns with global regulatory expectations, including those from the US Food and Drug Administration, European Medicines Agency, International Council for Harmonisation, and World Health Organization.

Get the templates now: https://bit.ly/45MgqEj

We’re proud to recognize United Therapeutics as a 2025 ISPE Facility of the Year Awards (FOYA) Honorable Mention for its...
09/02/2025

We’re proud to recognize United Therapeutics as a 2025 ISPE Facility of the Year Awards (FOYA) Honorable Mention for its Clinical Xenotransplantation Designated Pathogen-Free (DPF) Facility in Christiansburg, Virginia. In a rare exception from traditional FOYA categories, the judging committee honored this facility for its groundbreaking focus on unmet medical needs and its potential for significant social impact. As the first clinical-scale DPF operation submitted to FOYA, the 62,000-square-foot facility addresses a critical gap in healthcare, particularly for patients with end-stage renal disease.

This is the first of its kind facility, scaling up from a research and development operation to a state of-the-art clinical trial-ready, and sets the stage for a new era in medical treatments, creating a pipeline for groundbreaking therapies that could change the landscape of organ transplantation worldwide. With its forward-thinking design and transformative mission, United Therapeutics is paving the way for a new era.

Read the full blog to learn more about United Therapeutics' innovations:https://hubs.la/Q03G61P90

Be there when the spotlight shines! Get your ticket to the 2025 ISPE FOYA Banquet and Awards Celebration and find out who the overall winner will be: https://hubs.la/Q03G62rW0

The newly updated "ISPE GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data – Good...
08/30/2025

The newly updated "ISPE GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data – Good eClinical Practice (Second Edition)" offers expanded insights to meet the evolving demands of today’s clinical trial landscape. With the rise of digital health technologies, artificial intelligence, decentralized trial models, and heightened regulatory scrutiny, this edition reflects the increased complexity in ensuring compliance and data integrity.

The Guide delivers actionable strategies for validating computerized systems used in hybrid and decentralized trials. It covers critical areas such as managing third-party vendors, integrating participant-owned devices, deploying AI-driven tools, and handling open-source software. Additional focus is placed on real-world data use and strengthened approaches to data privacy and protection.

Explore the Guide: https://hubs.la/Q03G5p_F0

Staying current in today’s rapidly evolving life sciences industry requires ongoing professional development. As an ISPE...
08/29/2025

Staying current in today’s rapidly evolving life sciences industry requires ongoing professional development. As an ISPE member, you gain access to exclusive discounts on premier industry events and conferences both in-person and virtual. These savings make it easier to stay informed, connect with global experts, and gain insights into the latest technologies, regulatory trends, and best practices shaping pharmaceutical manufacturing.

Plus, when you join or renew your membership using code ISPEFUTURE25, you’ll also gift a free student membership to an aspiring professional at no extra cost. It’s a powerful way to invest in your own career growth while supporting the next generation of pharmaceutical leaders.

Join or renew now: https://hubs.la/Q03FWzBz0

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