
Accelerating AI Trust in Pharma: A Design Qualification Blueprint for AI in GMP Environments Webinar
Demonstrating Fitness for Use and Regulatory Compliance for Validated Processes Utilizing a DQ Approach to AI
June 24, 2025 | 12:00-1:00PM EST
The promise of Artificial Intelligence in biotechnology and pharmaceuticals is immense, from accelerating drug discovery to optimizing clinical trials and enhancing manufacturing. Realizing this potential within highly regulated environments demands more than just innovative algorithms; it requires a robust design qualification framework in support of process validation.
Join us for this essential webinar with Jason Dow—a recognized expert on critical topics such as Computer Software Assurance, Data Integrity, and qualification/validation strategies for next-generation technologies such as AI—where we will delve into a practical design qualification (DQ) approach to demonstrating your AI models utilized in validated processes are designed effectively and meet the stringent requirements of regulatory agencies.
In this 1-hour webinar, you will learn:
The critical role Design Qualification (DQ) plays in establishing confidence and trustworthiness in AI models.
How DQ of AI models fits within the larger umbrella of process validation.
Practical steps you can take to document the critical elements of your AI model designs to support DQ.
Techniques to accelerate adoption of AI models within validated processes; leverage DQ and SDLC effort to confidently deploy AI innovation.
Common challenges and pitfalls for regulated use of AI and how to navigate them.
Who should attend?
This session is tailored for IT professionals, Quality Assurance specialists, and data scientists navigating the complexities of AI adoption in GMP regulated spaces.
Meet the Speakers
Jason Dow
Jason Dow is the Owner and Principal Consultant of JP Dow Consulting, bringing 20+ years of experience in the pharmaceutical and biotech industries. With a deep expertise in IT Compliance, Computer Systems Validation, and Data Governance and Integrity, he has a proven track record of driving successful, large-scale initiatives that enhance organizational compliance and operational efficiency. Jason’s leadership is defined by his innovative approach to solving complex data integrity challenges. He has successfully launched and scaled data governance programs, defined and executed comprehensive remediation plans in response to regulatory findings, and spearheaded investigations into data integrity failures, focusing on root cause analysis and corrective actions.
Bill McGuckin
Bill has a proven track record of transforming teams and aligning top talent with organizational missions. He has spent much of his career building highly effective teams and mentoring future leaders. Prior to co-founding The Oxenham Group, Bill held leadership roles at top companies in the areas of Technology, Engineering, Compliance and Life Sciences.