PDA Week 2026

The PDA Industry and Honor Awards shine a spotlight on members and companies whose leadership, innovation, and volunteer contributions have made a lasting impact on both the industry and the Association.

Established in 1958, these prestigious awards represent one of PDA’s most enduring traditions, one that feels especially meaningful as PDA celebrates 80 years in the United States and 20 years since expanding into Europe, marking our strong and growing global presence!

Each year, we honor extraordinary individuals and teams whose work strengthens our global community and moves the field forward. This annual celebration, hosted at PDA Week, sets the tone for an immersive week filled with cutting-edge education, visionary plenaries, hands-on training, workshops, exhibitions, and countless opportunities to make meaningful connections. It’s a night of recognition, inspiration, and community you won’t want to miss!

Innovation in aseptic processing is accelerating, fueled by advanced technologies, automation, and shifting patient needs. However, regulatory uncertainty and a culture of risk aversion continue to challenge progress. This roundtable will explore how the industry can balance the drive for innovation with the need for compliance and control.

Bringing together stakeholders from the industry (e.g., health authorities, pharmaceutical manufacturers, and OEMs), the session will foster a collaborative dialogue on evolving regulatory frameworks, overcoming internal resistance to change, and cultivating a mindset that embraces calculated risk and continuous improvement. Through case studies and expert insights, participants will identify actionable strategies—from agile development models to proactive regulatory engagement—that enable innovation without compromising product safety.

Attendees will leave with a clearer understanding of how to navigate regulatory and organizational hurdles, and with practical approaches to unlock the full potential of aseptic innovation. This discussion is highly relevant to industry leaders seeking to shape a future where innovation and assurance work hand in hand to drive meaningful progress.

The biomanufacturing industry is asking: How do we integrate Gen AI without sacrificing human expertise? Join us for an interactive discussion on the Human-AI Training Parallelization system, a novel approach developed to empower people and processes in Life Sciences. We’ll start with an overview of where our industry is with AI use, and how AI Implementation is going, and its biggest opportunity: People.

Then we’ll explore two methods: Human-AI Training Parallelization: Learning (HATPL), which uses Digitally Interactive SOPs (DISOPs) to create competency-focused training and robust assessments, and Project-Based Human-AI Training Parallelization (PBHATP), which integrates AI Assistant development to capture tribal knowledge and boost project efficiency.

Bring your device! We'll dedicate a portion of the session to using Gen AI tools to simulate the method’s utility, fostering peer-to-peer problem-solving on key issues like knowledge transfer and continuous improvement. Let’s discuss the future of AI implementation in your organization and how to make it a people-centric process.

Key Discussion Points

• Workforce Pulse: Current challenges in biomanufacturing training and knowledge retention
• Live Demo: Interactive use of a Gen AI tools to mirror our approach
• Strategy Exchange: Best practices for integrating AI to enhance, not replace, human expertise

AI, digitalization, new modalities, and other advances in manufacturing technologies are all speeding towards us at a breakneck pace transforming the way we have made medicines in the past and challenging the traditional approaches to quality systems. A prepared and enabled Quality workforce is key to achieving a proactive, responsive and sustainable quality system able to provide the guard rails for change implementation without compromising innovation; and to ensure patient safety while not creating a bottleneck.

This roundtable will explore through scenario discussion and shared learning what approaches are working in Quality organizations today that can spark innovation in your own teams.

Discussion topics may include:

• Embracing health authority transparency
• Quality system integration
• Improving signal detection
• Enhanced change assessment
• Upskilling workforce capabilities
• Streamlined decision making
• Predictive modeling

Don't miss this opportunity to future proof your teams.

Ready to elevate your communication and networking skills? This interactive session is designed for students, early career professionals (ECPs), and anyone looking to approach professional conversations with more clarity and confidence. Guided by industry experts, you’ll explore practical strategies to strengthen your communication style and build connections that last beyond PDA Week. You’ll leave ready to approach networking not as a challenge, but as an opportunity to grow, learn, and meet people who can help shape your career.

Generative AI technologies—such as Large Language Models (LLMs) and Large Reasoning Models (LRMs)—are quickly making their way into pharmaceutical quality and regulatory operations. Their successful adoption requires shared literacy, clear expectations, and strong compliance foundations.

This mini-workshop will establish a common vocabulary for AI so QA, regulatory, IT, and leadership teams can communicate effectively. It will then explore the evolving regulatory landscape, including expectations from FDA, EMA, MHRA, and the EU Commission, with discussion of validation, audit readiness, traceability, human-in-the-loop oversight, and context-of-use classification.

Participants will examine key architecture considerations—such as model design, memory behavior, inference endpoints, and prompt controls—and how these choices directly influence compliance and operational performance. The session will also outline practical deployment strategies, from piloting and scaling to measuring ROI while maintaining GxP requirements.

This mini-workshop will equip attendees with the clarity, tools, and real-world insights needed to confidently evaluate and implement generative AI within regulated pharmaceutical environments.

Join PDA for a fast-paced, high-energy networking session! This dynamic event features a series of quick, 4-minute conversations designed to help you rapidly expand your network, spark fresh connections, and meet peers across the industry.

Bring your elevator pitch, business cards, LinkedIn QR codes, and magnetizing energy! Everyone is welcome.

PDA is excited to offer its first-ever guided Solution Partner Tours, designed to help attendees efficiently explore the equipment, technologies, and services most relevant to their work. Led by subject matter experts, these small-group tours will spotlight key exhibitors on the show floor, making it easier to discover the right partners, solutions, and innovations to support your projects, teams, and organizational goals.

This mini-workshop will offer a practical, integrated roadmap for developing safe, effective, and reliable drug–device combination products. Participants will explore core development challenges, essential design principles, and the role of systems engineering in managing lifecycle complexity.

Building on this foundation, the session will introduce a structured approach to modeling safety and effectiveness, highlight key safety engineering tools, and outline assurance milestones that help teams anticipate risks, strengthen controls, and meet regulatory expectations.

Real-world case studies will demonstrate these concepts in action—from leveraging existing platforms to designing interoperable systems and evaluating disruptive, next-generation technologies.

Kick off PDA Week 2026 in true Colorado style at Monday’s Welcome Reception! Throw on your preferred plaid and step into a mountain-inspired evening filled with glowing lanterns, campfire vibes, and that crisp alpine air the Rocky Mountains do best. Dig into hearty chili, cornbread, and gooey s’mores as evergreens and starry skies set the scene.

Toast to 80 years of PDA in the U.S. and 20 years since our expansion into Europe with local craft beer and whiskey while live music keeps the mood lively. It’s the perfect chance to settle in, mingle, and start the week wrapped in comfort and camaraderie, all fueled by flannel-fest fun!

This short introductory course covers the current requirements of Environmental Monitoring, reviewing the current requirements for total monitoring, it reviews the steps involved in a risk assessment to determine the location and frequency of sampling, including a hands on session in how to perform a risk assessment. How to design a system that meets the requirements of the Risk Assessment including instrumentation types required for the automated monitoring of total particle, microbial and rapid microbial technology integration, and closing with a review of appropriate Alert and Action levels and limits, and finally – what data needs to be reported, and how.

Attendees will leave with a thorough understanding of the steps between needing an EM system, and how to implement and use a system.

This mini-workshop will guide participants in developing practical data governance (DG) programs that deliver quality data aligned with business and compliance needs. The workshop will introduce core DG principles and show how they are emerging in regulatory frameworks such as the draft EU GMP Chapter 4 and ICH E6 (R3). Participants will explore how DG connects quality risk management, knowledge management, and data management, linking data integrity (ALCOA) and data quality to applied quality intelligence for sustainable compliance and stronger decision-making. Through interactive group work and role-play scenarios, attendees will design and test DG strategy elements using real-world use cases.

Unwind after a busy day at PDA Week with a slow, calming evening yoga session designed to help you reset and relax. This gentle class blends a slow-flow sequence, long holds, and restorative postures—perfect for settling both mind and body before turning in for the night. All levels are welcome, and no prior yoga experience is needed. Wear comfortable clothing you can move in, just show up and enjoy; mats will be provided, and post-session tea will be available. Join us for a peaceful evening reset.

Join us for a lively evening of friendly competition, great food, and plenty of fun at the PDA Battle of the Bags Cornhole Tournament! Player tickets give you full access to the action—step onto the court, compete in quick-paced matches, and enjoy a friendly, high-energy atmosphere. Players will be paired into teams onsite, no partner or prior experience needed. With multiple courts running at once and an easy-to-follow format, the tournament moves fast and keeps the excitement high. Come play, eat, and connect in a relaxed, spirited setting. Player spots are limited, secure your place early!

Want in on the fun without joining the tournament? Grab a Spectator Ticket and enjoy the full social experience at the PDA Battle of the Bags Cornhole Tournament! Settle into the cheering section, enjoy dinner, and watch as teams face off in quick, high-energy matchups for trophies and bragging rights. It’s the perfect way to relax, socialize, and take in the excitement of the tournament – no gameplay required. Come cheer, eat, and connect in a laid-back, high-spirit atmosphere!

This mini-training course is designed to equip personnel with the knowledge and practical skills required to maintain contamination control in pharmaceutical cleanrooms. It will cover the principles of Good Manufacturing Practice (GMP), proper gowning techniques, and cleanroom behavior essential for ensuring product integrity and patient safety. Attendees will get to apply knowledge with a hands-on experience with gowning supplies.

This essentials workshop is based on PDA Technical Report No. 22: Process Simulations for Aseptically Filled Products, as well as relevant topics from PDA Points to Consider for Aseptic Processing: Part 2, and the EMA draft Annex 1 revision. It will address various elements required in the design and execution of aseptic process simulations to include personnel qualification, media selection and preparation, filling considerations, interventions, duration, and number of units filled, pre and post incubation inspections, incubation conditions, acceptance criteria and investigations and corrective actions. The use of risk-based decision making will be considered.

A comprehensive contamination control strategy (CCS) transcends a mere compliance document. A CCS embodies a suite of contamination control principals integral to a company’s all-encompassing approach to managing, mitigating, and assessing contamination risks. The efficacy of each CCS component is closely tied to the collective performance, with the overall success of the CCS hinging on the cooperation of its parts to minimize contamination threats in each process. A well-implemented CCS serves as a conduit for knowledge sharing and continuous improvement.

This essentials workshop will dive into the practical application of CCS development, moving beyond theory to develop the essential skills for creating a comprehensive CCS. These strategies encompass every facet of production, from facility layout and utilities to environmental management, validation, monitoring, quality systems, personnel, and operational processes.

Participants will receive a complimentary copy of the PDA Technical Report No. 90: Contamination Control Strategy Development in Pharmaceutical Manufacturing (TR 90), a valuable resource for essentials workshop preparation. This interactive essentials workshop is your gateway to understanding CCS and its implementation in your manufacturing settings — a hands-on guide to formulating and executing an effective CCS.