ISPE DVC Multi-session AI in Pharma and Biotech Program: A Comprehensive Learning Experience
Join us for an immersive educational event that explores the transformative impact of artificial intelligence on pharmaceutical and biotechnology manufacturing. This multi-session program combines expert panel insights with deep dive breakout sessions, providing both strategic perspectives and practical implementation guidance for AI in GxP-regulated environments.
Who Should Attend
This comprehensive program is designed for life sciences professionals across all functions:
- Quality Professionals seeking AI validation and compliance strategies
- Manufacturing Leaders exploring AI implementation in production
- IT and Digital Leaders planning AI technology roadmaps
- Regulatory Affairs professionals navigating AI guidance
- Marketing and Business Teams looking for practical AI applications
- Engineers and Technical Staff interested in hands-on AI tools
- Executives developing AI strategy and governance frameworks
Why This Event Matters
Get authoritative guidance from practitioners who are writing the industry standards, see live demonstrations of cutting-edge applications, and network with peers facing similar AI implementation challenges. This event combines strategic insights with practical tools you can apply immediately in your organization.
Leave with: Clear understanding of AI fundamentals, practical implementation strategies, regulatory compliance approaches, and a network of peers navigating similar challenges.
Schedule of Events:
3:30 PM: Check-in and Networking
4:00–4:45 PM:
Panel discussion (Impact of AI in the Pharma/Biotech Space) Sandra Bones (Moderator)
Ryan Ciarcia (Panelist)
Steve Ferrell (Panelist)
David Lerner (Panelist)
Eric Staib (Panelist)
4:45–5:00 PM: Networking Break
5:00–5:45 PM:
First Round of Breakouts
Session A: Sandra Francesca Bones, CPSM
Demystifying AI: Fundamentals, Prompting, and Marketing Use Cases
Session B: Eric Staib and Steve Ferrell
AI Guidelines and Implementation Strategies
5:45–6:00 PM: Networking Break
6:00–6:45 PM: Second Round of Breakouts
Session A: Ryan Ciarcia
AI-Driven Quality Management Workflows
Session B: David Lerner, UST and Kuruvilla 'Mat' Mathew
Vision AI as a Cleanroom Companion: Lessons from a Live RABS Pilot
6:45–7:30 PM: Networking, Food, and Beer & Wine
Panelists/Presenters:
Sandra Francesca Bones, CPSM
Marketing and AI Consultant, Good Bones Marketing, LLC; President, ISPE-DVC
Sandra Francesca Bones, CPSM, is a B2B Marketing and AI Consultant and fractional leader for the Life Sciences Industry and owner of Good Bones Marketing, LLC. With two decades of experience, Sandra partners with businesses to develop and implement high-impact marketing and AI strategies, driving growth and efficiency.
As a Certified Professional Services Marketer (CPSM) with a certificate in Digital Marketing Strategies - Data, Automation, AI & Analytics, Sandra leverages deep industry insights and expertise in strategic marketing, branding, and integrated campaigns. She collaborates with marketing teams or external agencies, providing strategic vision and mentorship to utilize AI-enhanced content creation, prompt engineering, and automation for enhanced marketing strategies and productivity.
Ryan Ciarcia
General Manager, PSC Software
Ryan Ciarcia is the General Manager of PSC Software, a global software organization, where he leads strategy and innovation with a focus on securely integrating AI into the company's enterprise Quality Management System, ACE. His career spans software, IT, sales, and leadership in highly regulated environments. He is nearing completion of his Doctorate in Technology at Purdue University, where his research examines the role of AI in leadership and decision-making.
Stephen Ferrell
Chief Product Officer, Valkit.ai
Stephen Ferrell is Chief Product Officer at Valkit.ai, where he leads AI-augmented compliance solutions for life sciences and healthcare organizations. With over 20 years in IT governance, software assurance, and cybersecurity, he specializes in regulatory frameworks and product leadership.
Steve co-chairs GAMP Americas and serves on the ISPE GAMP Global Steering Committee. He led development of ISPE's GAMP IT Infrastructure Control and Compliance Guide (2nd edition) and contributed to GAMP 5, 2nd Edition and the new ISPE AI GAMP Guide. His work helps organizations manage regulatory compliance and operational efficiency in highly regulated industries.
David Lerner, UST
Quality and Compliance Practice Lead, Life Sciences
David specializes in transforming business operations within quality, R&D, regulatory and manufacturing operations in the pharmaceutical and medical device industry. David has provided guidance across regulatory, quality and clinical functions. David is also a GCP and GMP quality expert, providing advice to on their Quality Management Systems, and preparing and responding to regulatory authority inspections. David was a co-author of the GAMP MES guide. Recently, David has been working on implementation of AI used cases within Life Science, including UST’s Sentry AI solutions. David graduated with a BS in Mechanical Engineering from Lehigh University and a MBA from University of Texas at Austin.
Kuruvilla 'Mat' Mathew
Chief Innovation Architect & General Manager - Modernization
As the Chief Innovation Architect, Mat leads Digital Innovation initiatives for organizations that are looking towards applying innovation to transform their business with new disruptive ideas. He has the overall responsibility to develop and manage the innovation portfolio of innovation-led services. Mat helps UST’s customers migrate legacy and dated traditional services by developing next-generation digital solutions using AI. Being the Chief Innovation Architect, he serves as the lead change agent for digital process innovation by developing leading edge functionality and AI technologies. He has responsibilities on Innovation Services, Vision AI, Immersive Experience at UST, helping UST customers through Problem to production in 12 weeks. Mat holds multiple utility patents in IoT where they were applied to different industries. Mat graduated with a Bachelors in Engineering in Computer Engineering from the University of Pune.
Eric Staib
Vice President, Syneos Health
Eric Staib is the Vice President of Corporate Quality at Syneos Health. He has more than 25 years of pharmaceutical industry experience in various GXP areas, including direct experience and leadership for quality systems development/management, software quality engineering, information technology, and computer systems validation/assurance (CSV/CSA). He holds a BS in biology from James Madison University, an MS in quality assurance and regulatory affairs from Temple University, a graduate certificate in project management from Lehigh University, and an MBA in pharmaceutical management from Drexel University. Eric was a previous Chair of the GAMP Americas Steering Committee for ISPE, chairs a Software Automation and Artificial Intelligence Special Interest Group (SIG) and currently serves as Secretary of the AI CoP. He has presented at numerous industry conferences in addition to having published and contributed to several concept papers, magazine and journal articles, and good practice guides; including the 2nd edition of GAMP5 and the new GAMP AI Guide. Eric has been an ISPE member since 2001 and is a recognized GAMP instructor.
Opening Panel: Impact of AI in the Pharma/Biotech Space
Join us for a panel discussion exploring the transformative role of artificial intelligence in pharmaceutical and biotechnology manufacturing. This session will bring together industry experts across regulation, technology, manufacturing, and quality to examine how AI is reshaping GxP-regulated environments.
What You'll Learn:
This fast-paced discussion addresses the essential questions every pharmaceutical professional needs answered about AI implementation, including real-world use cases that have progressed beyond pilot programs, validation strategies for "black box" AI systems, risk assessment approaches for AI bias and drift, and the critical barriers to integrating AI into GMP production environments.
The panel addresses data quality challenges, workforce skill requirements, and emerging regulatory guidance, while providing rapid-fire insights on the most overhyped and underrated AI opportunities in the pharmaceutical industry.
Why Attend:
Get concentrated insights from practitioners who are literally writing the industry guidance on AI implementation, including key contributors to the new ISPE GAMP AI Guide. This session provides a solid foundation for the in-depth technical breakout sessions that follow, where you'll see live demonstrations, detailed implementation strategies, and real-world case studies.
Perfect for ISPE members seeking authoritative guidance on responsibly integrating AI into pharmaceutical operations while maintaining the highest standards of quality and compliance.
Session Descriptions
Session 1-A: Sandra Francesca Bones, CPSM; Demystifying AI: Fundamentals, Prompting, and Marketing Use Cases
Have you heard about AI but still don’t know the fundamentals or know how to get started? This session is for you. Artificial intelligence is reshaping how life sciences organizations work, but for many professionals, the fundamentals still feel confusing or out of reach.
In the first half of this session, Sandra Bones, CPSM, a consultant who helps life sciences marketing teams integrate AI into their workflows, will explain the fundamentals of AI in plain language so you will become comfortable with the terminology and have the knowledge needed to start using it.
In the second half, you’ll see practical tools, live demos, and real-world marketing use cases that you can apply to your team or your personal life immediately.
What You’ll Learn
- Accessible introduction to how AI actually works
- How to write clear, effective prompts to get high-quality outputs
- Overview of tools on the market
- Industry-specific use cases
- Responsible use of AI
- How to get started with implementing AI in your organization
Format
- Visual slides for clarity and engagement
- Live demo using real prompts and real tools
- Q&A to address attendee-specific challenges
Who Should Attend
This session is designed for life sciences professionals of all backgrounds including marketers, quality professionals, engineers, and IT leaders who want to understand AI without the hype and start using it with confidence.
Session 1-B: Eric Staib and Steve Ferrell; AI Guidelines and Implementation Strategies
Dive deep into regulatory frameworks and practical implementation approaches with two of the industry's leading AI guidance experts. Learn from contributors to the new ISPE GAMP AI Guide about navigating compliance requirements and building robust AI governance structures.
Key Topics:
- Current and emerging regulatory guidance for AI
- GAMP framework evolution for AI applications
- Risk-based validation approaches
- Implementation roadmaps and best practices
- Compliance strategies for AI in GxP environments
Session 2-A: Ryan Ciarcia; AI-Driven Quality Management Workflows
In this session, Ryan Ciarcia will demonstrate how artificial intelligence is transforming electronic Quality Management Systems (eQMS) by combining generative AI, machine learning–driven analytics, and natural language reporting into real-world workflows. The presentation will showcase how these capabilities can be applied to mass balance tracking, enabling organizations to streamline data capture, uncover deeper process insights, and generate intuitive reports that enhance decision-making. Attendees will learn how AI automates compliance-driven tasks while enhancing the strategic value of quality systems in highly regulated environments..
Session 2-B: David Lerner and Kuruvilla 'Mat' Mathew; Vision AI as a Cleanroom Companion: Lessons from a Live RABS Pilot
The evolution of Vision AI has moved past vision inspection to a tool which operators use to assure proper execution of their procedures.
In aseptic pharmaceutical manufacturing, deviation, like first-air disruption or visual glove inspection or adherence to hand sanitization protocols, can cascade into major compliance risks and costly batch losses. What if these anomalies could be detected and alerted before they escalate?
We will show video of a digital twin of a RABS to demonstrate the use cases that has used in an actual manufacturing environment. The solution provides real time alerts to operators and supervisors on anomalies in the production line, before they impact quality and productivity.
This presentation will offer valuable insights into:
- Technology background with the differentiation between visual inspection and Vision AI
- Share video demonstrations of aseptic technique compliance use cases
- Human-machine collaboration in cleanrooms: how operators are responding to AI-generated alerts
- Early wins and lessons from integrating Sentry Vision AI within a RABS aseptic fill-finish environment
- Path to identify and decide on most appropriate use cases
- Approach to create and deploy Vision AI models
- Additional use cases for Vision AI (aseptic and non-aseptic environments)
- Discuss expected benefits and challenges
- Q & A
This session is ideal for pharma professionals exploring how to safely and strategically pilot AI led initiatives. Attendees will leave with a clearer view of how Vision AI can become an ally in their digital quality transformation journey.
Registration will open at 3:30 pm; the panel discussion will begin at 4:00 pm and breakout sessions will begin at 5:00 pm.
Cancellation Policy: Full refund or credit voucher for a future program will be given up until 7-days before program; After October 14th, no refunds or credit vouchers will be provided. Registration website will close at 5:00 pm on Monday, September 15th.