AIO Work Team Goal
The AI in Operations Team (AIO) is an organized, cross-industry discussion group of FDA officials and industry professionals working to increase the predictive assurance of product quality across all operations (e.g.., manufacturing, quality, supply chain, etc.) through the power of AI.
AIO Problem Statement
The medical device and pharmaceutical industries are anxious and hesitant to expand their use of artificial intelligence in operations. The saying “I want to be the first to be second” rings true in some cases, while others are forging ahead. The AI in Operations Team is collaboratively working to increase the awareness of how AI is already being used, and exploring additional applications.
AIO Work Team Deliverables
In February of 2022, the efforts of Xavier Health were assumed by the AFDO/RAPS Healthcare Products Collaborative. Because of the important work done before this transition, the Collaborative has chosen to retain documents that have Xavier branding and continue to provide them to the communities through this website. If you have questions, please contact us at info@healthcareproducts.org.
2021
- Whitepaper: Maturity Level Characterization of AI Capabilities for Self-Assessment (Link)
- Whitepaper: AI in Manufacturing Process Improvement (Link)
- AI Checklist Tool (no longer available)
2020
2019
Survey results that measure the current status of how AI is being used in manufacturing
2018
System Map demonstrating interconnectivity and potential causal relationships between GMP systems, non-GMP systems and the complaint system:
Summary of data elements that represent risks and/or potential failure modes for the events captured in the complaint system:
Definitions of AI relevant terms to harmonize understanding:
Team Leaders
George
Brunner
George Brunner serves as Chief Data Scientist at Acumen Analytics, a Philadelphia-based technology solutions provider serving pharmaceutical, biotech, and manufacturing industries since 2004. The award-winning WBE company specializes in advanced analytics and data-driven transformation in life sciences, combining industry expertise with innovative technology solutions.
Lacey
Harbour
Lacey Harbour is a Molecular Biologist turned Regulatory, Quality, and Clinical Strategist, experienced in bringing diverse medical devices to market. She specializes in validating machine learning algorithms in healthcare, focusing on safety and effectiveness. Through AFDO/RAPS involvement, she advocates for state-of-the-art medical care while ensuring patient safety and global accessibility.
Cindy
Ipach
Cynthia Ipach, President and CEO of Compliance Insight, Inc., founded the company in 2000. With over 30 years in pharmaceuticals, medical devices, dietary supplements, and biologics, she has guided hundreds of companies through FDA compliance. Starting in Analytical Research and Development, she moved to Regulatory Affairs and Quality Assurance before serving as Director of Scientific Affairs at Pharmacia. Recently, she co-leads AFDO/RAPS’s AI in Operations Group, developing AI maturity models for healthcare.
Toni
Manzano
Manzano co-founded Aizon, providing AI SaaS platforms for Biotech/Pharma, and co-leads PDA’s CPV and Biomanufacturing groups. He teaches AI, advises Spanish Parliament and UN on AI in biopharma, and holds patents in data processing for regulated environments. A physicist with expertise in information systems and pharmaceutical quality, he contributes to industry publications.
Matthew
Schmucki
Matt serves as Associate Director for data automation and engineering at Vertex Pharmaceuticals, managing manufacturing data analytics across internal and external partnerships. With 15+ years supporting various pharmaceutical products, he brings expertise from startups to major pharma companies. He holds a mechanical engineering degree from University of Cincinnati and Doctorate in Business Intelligence, and guest lectures at Xavier University’s Quality Science programs.
Sundar
Selvatharasu
Sundar Selvatharasu serves as an FDA compliance expert, providing strategic solutions for emerging technologies across biopharma, medical devices, and healthcare industries. He collaborates with regulatory officials globally, leads multinational audits, and regularly speaks on security, data integrity, and quality systems. He contributes to industry publications and training on technology adoption compliance.
Kip
Wolf
Kip Wolf brings 25+ years of management consulting experience, with expertise in quality assurance, regulatory affairs, GMP compliance, and business transformation. He previously led business process management at Wyeth Manufacturing and Merck R&D, and headed the data integrity practice at Tunnell Consulting. He holds an MBA and Management of Information Systems degree from Eastern University, with graduate studies in Drug Development from Temple University.
Join the AIO Work Team
You have an opportunity to work with your industry and regulator peers to develop solutions that will advance the predictive capabilities of the industry.
The AIO Team operates virtually from September through August each year, and is led by a structured leadership team toward predefined goals and deliverables.
The team leaders present the outcome of the work during the AI Summit that occurs each August. You will be recognized for your contributions at the Summit and in team publications.
Meeting frequency and duration is based upon what is needed to support progress against the deliverables. Team members volunteer to work on specific aspects based on their expertise.
If you are interested in joining the AIO Working Team, please note:
- There is an annual participation fee of $100* per team to support Healthcare Products Collaborative’s ability to lead these initiatives.
- It is expected that you participate in the standing meetings (schedule is determined by each team).
- Plan on a time commitment of 5 hours per month, but this may vary.
