The International Society for Pharmaceutical Engineering - ISPE

09/11/2026

The new ISPE Guide: Oligonucleotide and Peptide Manufacturing Facilities is now available.

Get the Guide: https://hubs.la/Q04xclx00

The pharmaceutical industry has long faced the challenge of balancing speed to market, cost, and regulatory compliance, a balance that becomes even more difficult for new modalities where facility templates have yet to be developed.

Written by a global team of subject matter experts with decades of experience in oligonucleotide and peptide manufacturing, this Guide delivers the industry's first comprehensive facility-focused resource dedicated to these rapidly evolving therapeutic modalities. It establishes a practical baseline for the planning, design, construction, commissioning, qualification, and operation of GMP manufacturing facilities that protect the process, product, and ultimately the patient, while keeping operations cost-effective and sustainable throughout the facility lifecycle.

09/11/2026

Are you ready to share innovative strategies, breakthrough concepts, or proven best practices with your industry peers? The 2027 FDA ISPE Compounding Quality Center of Excellence Conference is your platform to showcase expertise and drive the compounding community forward. Join us in Washington, D.C., USA, from 11–12 March to present your work and connect with peers.

Submit your proposal today: https://hubs.la/Q04xb84Y0

This is your opportunity to lead the conversation in one of these key content areas:
• Regulatory Landscape
• Customer Partnerships
• Current Good Manufacturing Practice (CGMP)
• Quality Culture
• Supply Chain and Manufacturing
• Facilities and Technology
• Inspections and Auditing

09/10/2026

ISPE Academy’s Quality Essentials certificate program provides a comprehensive foundation in the core principles, processes, and expectations that underpin a robust pharmaceutical quality system.

Designed for professionals working in or entering GMP-regulated environments, this multi-course program builds a deep understanding of quality events, controlled documentation, and the supporting quality elements essential for sustaining compliance, data integrity, and operational excellence throughout the product lifecycle.

After passing the final cumulative knowledge assessment with a score of 80% or higher, you'll earn a certificate of completion and CEUs to showcase your achievement and commitment to continued growth.

Learn more and enroll today: https://hubs.la/Q04x7DBC0

09/10/2026

AstraZeneca’s Commercial Cell Therapy Facility in Rockville, Maryland, is setting a new benchmark for how pharmaceutical manufacturers can deliver lifesaving therapies while simultaneously advancing sustainability and operational excellence.

Recognized as the 2026 ISPE Facility of the Year Awards (FOYA) Social Impact – Unmet Medical Needs Category Winner, the facility demonstrates how innovative engineering, risk-based design, and patient-centered thinking can transform commercial cell therapy manufacturing.

Congratulations to AstraZeneca on this well-deserved recognition. Read the full story on iSpeak: https://hubs.la/Q04wMCRF0

Be there when the spotlight shines. Get your ticket to the 2026 ISPE FOYA Banquet and Awards Celebration and find out who the overall winner will be: https://hubs.la/Q04wMCBz0

09/09/2026

ISPE membership connects you with professionals across the life sciences industry who can offer new perspectives, share practical experience, and help you stay connected to what is happening across the field.

The relationships you build today can become valuable sources of insight, support, collaboration, and opportunity throughout your professional journey.

Join ISPE and start building connections that can grow with your career. For a limited time, customize your experience with one complimentary learning pathway. Select the focus area most relevant to your goals:
• Artificial Intelligence (AI), Including AI in GxP Environments — use code: ISPE26AI
• Pharma 4.0™ Digitization Journey — use code: ISPE26PHARMA
• Sustainability — use code: ISPE26SUSTAIN

Access more than 15 expert-led technical sessions from recent ISPE conferences now: https://hubs.ly/Q04wMyl10

09/08/2026

Join us at the 2026 ISPE Annual Meeting & Expo, 18-21 October, in Washington, D.C., USA, where pharmaceutical and biopharmaceutical professionals come together to explore the latest innovations, industry trends, and manufacturing solutions.

Thank you to our media partners, including Bioprocess Online, Pharmaceutical Online, Cell & Gene, and others, for helping us spread the word about this exciting event opportunity with the industry.

Register now: https://hubs.la/Q04wMwlr0

09/08/2026

CAPEX projects are crucial to expanding business and defending against an increasingly competitive landscape, but 95% fail to meet initial cost and time projections. Leading consultants such as McKinsey recommend embedding CQV directly into master schedules to protect projections.

Learn how to keep your CAPEX projects stay on budget, on time, and compliant in this sponsored content from Kneat: https://hubs.la/Q04wM7KJ0

09/05/2026

ISPE GAMP® Good Practice Guides provide practical, risk-based guidance to help you manage GxP computerized systems, support patient safety, product quality, and data integrity, and meet current regulatory expectations.

Explore featured ISPE GAMP® Good Practice Guides: https://hubs.la/Q04wMsf50

• ISPE GAMP® Good Practice Guide: Testing GxP Systems (Third Edition)
• ISPE GAMP® Good Practice Guide: GxP Process Control Systems (Third Edition)
• ISPE GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data – Good eClinical Practice (Second Edition)
• ISPE GAMP® Good Practice Guide: Enabling Innovation – Critical Thinking, Agile, IT Service Management
• ISPE GAMP® Records and Data Integrity Good Practice Guide: Data Integrity by Design

09/04/2026

Drug shortages have risen markedly over the past 20 years, reaching unprecedented levels. Large-scale disruptive events, such as natural disasters, cyberattacks, the COVID-19 pandemic, and geopolitical constraints, have further exposed vulnerabilities in global supply chains.

While these acute events can trigger significant shortages, more persistent challenges to supply continuity remain, including quality and manufacturing issues as well as non-compliance with Good Manufacturing Practices (GMP). The recognition of these growing and systemic challenges has led to the 2023 update of ICH Q9, reinforcing the role of quality risk management (QRM) in supporting supply continuity and ensuring product availability for patients.

The revision provides greater clarity on formality, subjectivity, product availability, and risk-based decision-making, while also reinforcing the critical role of knowledge management and senior leadership engagement.

ISPE released a new Guide on moving beyond a tool centric or compliance driven view of QRM toward a mature, value driven approach that is embedded within the pharmaceutical quality system.

Read more in this article:

Drug shortages have risen markedly over the past 20 years, reaching unprecedented levels.

09/04/2026

Looking to master the regulatory requirements for computerized systems?

Updated to include key takeaways from the ISPE GAMP® 5 Guide (Second Edition), this fundamental course introduces you to tried-and-tested and internationally recognized compliance methods.

Discover how to apply a pragmatic and effective framework to help your systems remain:
• Compliant with current regulations
• Fit for their intended use
• Aligned efficiently with existing industry good practices

Learn more and register for this 2026 Annual Meeting & Expo post conference training: https://hubs.la/Q04mFWpC0