VALIDATE 2023: 9 Key Takeaways in an Era of Digitization & Change

By Art Gehring, VP Marketing, Kneat

As a new member of the Kneat team, I had the opportunity to attend my first VALIDATE conference last month in vibrant and very windy Miami (gusts up to 20mph). VALIDATE 2023 was held on October 4-5 at the Miami Marriott Biscayne Bay. While the wind and sun were strong, the real energy was among the knowledge exchange, presentations, and discussions.

The theme of this year’s event showcased cutting-edge insights on digitization and organizational change and validation best practice, while fostering invaluable connections. Attendees left inspired and well-equipped for the future of validation and the era of digitization and change. For those of you who could not make the event and even for those who could, here are some of the highlights and key takeaways from VALIDATE 2023.

Audience members posed questions and stimulated discussion throughout VALIDATE 2023.

1. Sharing Expertise

Eddie Ryan, Kneat CEO and co-founder, launched VALIDATE 2023 by sharing expertise on why digitizing validation is crucial for the life sciences industry. He outlined how knowledge sharing:

• Accelerates innovation and competitiveness by enabling organizations to adopt best practices and cutting-edge technologies—This results in quicker product development, reduced time-to-patient, and increased cost efficiency.

• Enhances regulatory compliance—By collectively understanding how to adopt new technologies to ensure quality and safety standards are met consistently.

• Acts as a catalyst for progress—enabling the life sciences industry to deliver safer and more effective products to patients faster.

Keynote by April Callis-Birchmeier, Springboard Consulting

2. Embracing Change

VALIDATE 2023 focused on digitization and change starting with the opening keynote Embracing Change: Unlocking Success in the Digital Age, with April Callis-Birchmeier, an internationally known Change Management Expert at Springboard Consulting, who has implemented change for government, health care, higher education, and corporate clients.

In today’s fast-paced digital age, organizations are constantly bombarded with new technologies, operational challenges, and ever-evolving expectations. The life sciences industry, more than ever, needs strategies for not only adopting but sustaining digital projects. This keynote explored strategies and techniques to ensure organizations recognize realize the change that unlocks success in the digital era.

April outlined five steps to successful change for validation professionals:

1. Relevant and relatable messaging of the change

2. Engaging leaders as sponsors to actively promote the change

3. Advance communication to ensure messaging is received, and advocating for stakeholders

4. Develop support for training on process and technology

5. Reinforce why and reduce resistance to adoption

“If I could only attend one event a year this would be the one.”

Carolina Costa, Senior Specialist Multi Site Validation, GSK

Mock Audit, with Audrey O’Reilly, Merck, Patrick Mullin, Sanofi, and Sarah Grogan, Kneat

3. Audit Readiness

VALIDATE 2023 explored how modern technologies are reshaping inspection preparedness in highly regulated industries in three sessions spread over the conference.

Experts also demonstrated how digital tools and data management solutions are revolutionizing compliance and audit readiness. Kneat would like to thank all our speakers, including:

• Kathianne Ross, Manager of IT Compliance at Fujirebio Diagnostics

• Aubrey Hogan, Service Line Leader – Regulatory, Compliance, and Product Lifecycle Management at Verista

• Audrey O’Reilly, Director Global Quality and Compliance at Merck

• Patrick Mullin, Commissioning and Qualification Lead at Sanofi

Attendees learned about proactive measures and strategies needed to navigate regulatory inspections with confidence, showcasing the importance of staying ahead in the digital age.

All three sessions underlined the significance of integrating digital technologies to ensure not just compliance, but also efficiency and effectiveness in the face of inspections, marking a significant shift towards a more technologically advanced and prepared future.

Panel Discussion with Katie Brattlie and Tamara Redondo, National Resilience Inc., and Amy Kuntzman, CAI

4. Harnessing Kneat Implementation as a Change Agent for Harmonization

This panel discussion with Kate Brattlie, Senior Manager of Computer System Validation and Assurance,Tamara Redondo, Senior Manager, Digital Quality Systems at National Resilience, and Amy Kuntzman at CAI, unveiled the transformative potential of Kneat in driving harmonization within organizations. They illuminated how adopting Kneat Gx can catalyze alignment, standardization, and efficiency across diverse facets of an organization and various operations.

Attendees saw how documents, drawings, and data can be tools to enhance product quality and accelerate production, encourage collaboration, and ultimately lead to streamlined processes.

Case Study Presentation by Ryan Dunn, Merck and Dave O’Connor, No deviation

5. Digital Validation: Going Beyond Implementation With Merck

Day Two of VALIDATE 2023 opened with a case study presentation on digital validation roll out and beyond at Merck by Ryan Dunn, Global C&Q Lead, Global Engineering Solutions at Merck and Dave O’Connor, C&Q Digital Transformation Manager, at No deviation.

Post deployment opportunities highlighted included: further standardization, including of non-direct impact systems; building a global library of URS (vendor standard) for standard OEM equipment (autoclaves, WFI Skid, etc.,); and Kneat Gx’s Section Group Template feature to be used to globally standardize common testing requirements, such as P&ID Walkdown, Interlock, and alarm testing.

To learn more about MSD’s global digital validation rollout and how the company achieved a 50% cycle time reduction in test execution after implementation, read the full case study.

Panel Discussion with Matthew McMenamin, GSK, Nathan Storie, Takeda, and Rob Beane BW Design Group

6. Organization Structure and Change Management

This panel discussion led by Matthew McMenamin, Validation Global Process Owner, Quality at GSK, Nathan Storie, Associate Director, Global Lead Power User, e-Validation at Takeda, and Rob Beane, at Barry-Wehmiller Design Group showed how pharmaceutical giants navigate organizational transitions. This session elucidated the pivotal role of change management in fostering adaptability and innovation within complex corporate structures.

Attendees were privy to strategies that have helped GSK and Takeda optimize their organizational frameworks, foster employee engagement, and streamline operations. The real-world examples and practical advice shared emphasized that a well-planned organizational structure and effective change management are the cornerstones of success in the pharmaceutical industry.

Viraj Karekar, C&Q Manager and Bruce Klopfenstein, Senior CQV PM at MMR Consulting discuss validation and AI

7. The Future of Validation: Digital Validation With AI

This session was a glimpse into the next frontier of validation processes. Experts, Viraj Karekar, C&Q Manager and Bruce Klopfenstein, Senior CQV PM at MMR Consulting, delved into the transformative power of AI in the validation industry, offering a vision of a more efficient, data-driven, and accurate future. Attendees discovered how AI can automate complex validation tasks, reduce human error, and expedite product development.

This session underscored the importance of embracing AI-driven solutions in validation, paving the way for a future where technology not only simplifies compliance but also enhances the quality and safety of products, revolutionizing the validation landscape for years to come.

“Choosing my favorite session from the event is hard to do since they were all so good. But if I had to, the mock audit session and MMR’s discussion of AI were excellent.”

– Jon Edgar, Commissioning and Validation Team Leader, Hallam ICS

Case Study Presentation by Elizabeth Weaver and Thao Phan, Eli Lilly & Co., and Kristan Baker, VEQTOR

8. How Eli Lilly & Co. Digitized Validation

This case study presentation by Elizabeth Weaver, Senior Principal Engineer – Automation CSV and Data Integrity, Thao Phan, Advisor, Engineering Technical Center, at Eli Lilly and Kristan Baker, Director of US Kneat Services, Capital Projects & Digital Transformation at VEQTOR, detailed how Eli Lilly strategically embraced digitization to streamline and enhance its global validation processes.

Drivers for global adoption of Kneat Gx at Eli Lilly included the release of ISPE Baseline Vol. 5 (C&Q) 2nd edition, finalization of a new C&Q program, incoming interest from other sites, pandemic-related challenges, and a new greenfield site (digital plant).

9. Networking and Community Building

VALIDATE 2023 was more than a conference; it was a platform for building a strong, connected global validation community. Numerous networking opportunities, including social events, discussion groups, and interactive sessions encouraged attendees to exchange ideas, best practices, and form lasting connections.

Final Thoughts

VALIDATE 2023 was a clear reminder of the dynamic nature of quality, validation, and compliance. With technology driving change at an unprecedented pace, the need for adaptable solutions and agile processes has never been greater. The event underscored the critical role that flexible digital validation and compliance tools can play in streamlining workflows, reducing errors, ensuring data integrity and driving faster speed to market and significant productivity gains for organizations.

Thank You

Thank you to all our speakers, customers, partners, and attendees for making VALIDATE 2023 an unforgettable experience. Miami may have been the backdrop, but it was the people, the ideas, and the connections that truly made this event exceptional. This was a truly inspiring event that I would highly recommend.

A very special thank you to our sponsors, Cave Solutions, MMR Consulting, No deviation, ZETA, VEQTOR, CAI, Design Group, PharmEng Technology, VERISTA, PCI, and Ellab, for your support.

“I found VALIDATE to be one of the most engaging opportunities I’ve been to in recent months; I loved having an inside peek into what’s new and upcoming in the releases, and also learning from others their best recommendations for smooth implementation. The planning and execution was great. Thanks to the Kneat team in general for their outstanding service and technical expertise.”

– Joanne Meloro, Sr Director – Strategic Initiatives, IPS CQV

Join Us at VALIDATE EU 2024

As we look forward to the next VALIDATE conference in Europe, we can only imagine the incredible strides that will be made in validation and compliance, driven by the innovative spirit and collaborative strength of the validation community today.

See you at VALIDATE EU 2024!

About the Author

Art Gehring – VP Marketing, Kneat

Art joined Kneat in August 2023 and manages the global marketing function. He has over 30 years of experience in B2B software and Internet marketing, including Fortune 500 companies and highly regulated industries. Art has a BA in Economics from Kenyon College and an MBA in Marketing & Entrepreneurship from Babson F.W. Olin Graduate School of Business.