Good Morning Colleague,
Welcome to Day 3 of the PDA Regulatory Conference 2025!
Yesterday was a great second day for the conference. There was certainly plenty of incredible content and lots of opportunities to connect, discuss and network. A special thanks to the exhibitors for their continued support for the conference and their openness to share ideas, approaches and offer valuable perspectives.
And what could be more enjoyable after a very full day of excellent presentations and Q&A then the opportunity to relax at the Capital Area Whiskey Reception and the Lincoln's Last Night Walking Tour.
On Deck Today
A sneak preview of today’s program includes three plenary sessions and the always popular “Lunch with the Regulators” session. Kick off the day by taking advantage of one of the early morning Breakfast Sessions or IG meetings and during the morning break take the opportunity to learn more about PDA at our “Ask Me About PDA” Poster Session. Please explore all of your options via the agenda in your Mobile App or on the Conference webpage.
Selected Highlights From Yesterday
With so much incredible content we decided to focus the recap on P3: Data Integrity at the Next Level which tackled this critical issue facing the industry as it accelerates its generation, storage, and use of data.
Advancing DI: New Challenges, Practical Solutions
Data Integrity (DI) has evolved from best practice to regulatory expectation driven by global standards such as EU Annex 11, ICH E6(R3), and PIC/S Guidance. Peter E. Baker, MS, President of Live Oak Quality Assurance gave a thought-provoking presentation on the new challenges and practical solutions of DI focusing on data and process governance.
Using the scientific method model, governance can be framed in six stages: theory, hypothesis (planning), experiment, verification, practical challenges (think ROI), and ultimately, the proposed solution. Sounds logical? This systematic approach delivers effective governance that is not just a regulatory necessity but a strategic driver of corporate success. The key is aligning compliance with lean principles—a proven model of efficiency and quality. Success is dependent on the human factor to understand the process, support its value, and execute it.
Building a governance culture requires commitment at all levels, from senior management to middle managers and frontline employees. Data and process governance are no longer optional—they are expected by regulators worldwide. Companies that view governance through the lens of lean efficiency and ROI will gain not only compliance but also operational excellence, employee engagement, and a competitive advantage.
Building Resilient Data Systems: Governance and Good Practice
Dr. Carmelo Rosa, Division Director, Office of Manufacturing and Product Quality, OC, CDER , U.S., FDA, followed up Baker’s presentation with a regulatory perspective from the public sector. Dr. Rosa said that data governance is the foundation of resilient systems. This discipline involves data protection, management, quality, accuracy, usability, availability, integrity, consistency, transparency, and ownership. It is protected by strong policies, processes, and decision-making frameworks rooted in regulatory compliance and trustworthy data.
He stressed that resilient systems rely on strong communication and relationships, learning from past failures, accountability, and a continuous improvement culture. To ensure governance, organizations need a paradigm shift toward resilience.
How to accomplish this? Rebuild training programs and make DI a daily habit, not a yearly event. Strengthen oversight by expanding internal and external audits including DI specialists and implement robust governance by unifying corporate, site, and unit-level understanding of quality expectations. Foster quality culture with direct accountabilities, cross-functional collaboration, and incentives for innovation. Modernize systems by moving away from paper-based processes to reliable, technology-driven systems with secure controls. And finally, empower the QU –by ensuring adequate authority, resources, and independence to oversee operations effectively.
All these actions need to be supported by executive commitment with leadership that demonstrates quality by action, not just words. The result? Shifting from minimum compliance to quality by design, not by accident.
Attendee Survey
While we still have a full day ahead of us, we want to thank you in advance for joining this year’s PDA Regulatory Conference. It meant a lot to us at PDA and sets the stage for what is sure to be remembered as one of our best regulatory conferences. When you have a chance, we would be very grateful if you would take the time to fill out the Attendee Survey. Your feedback is vital to PDA’s continuous improvement journey.
Click on the link to access the survey.
Sincerely,
Janeen Skutnik-Wilkinson and Mary E. Farbman, PhD
PDA Regulatory Conference 2025 Co-Chairs
