AI is rapidly becoming part of everyday operations across the life sciences industry. While many organisations are eager to explore its potential, implementing AI within GxP environments requires more than simply applying existing Computerised System Validation (CSV) or Computer Software Assurance (CSA) approaches to a new technology. This webinar explores how GxP organisations can establish a compliant AI strategy built around risk, governance and regulatory expectations before implementation begins.
Developing a compliant AI strategy begins with the right mindset, a clear understanding of risk and a structured approach to governance. Without these foundations, organisations can unintentionally introduce compliance risks that become increasingly difficult to manage as AI initiatives expand.
The featured speakers will explore how organisations can define AI strategy or strengthen existing initiatives. Rather than focusing on the technical aspects of AI, the session will explore the organisational considerations that should be addressed before implementation begins.
Attendees will gain practical guidance on establishing awareness across the business, evaluating common implementation approaches, understanding key compliance considerations and creating a framework that supports both innovation and regulatory expectations. The discussion will also examine the differences between internally developed and externally provided AI solutions, helping organisations understand how governance responsibilities may vary.
By taking a pragmatic and business-focused approach, this webinar will provide attendees with practical considerations that can help them build AI initiatives that are both effective and compliant from the outset.
Whether a GxP organisation is just beginning its AI journey or looking to formalise its approach, this session will provide valuable insight into developing a sustainable AI strategy that aligns with GxP expectations while enabling innovation with confidence.
Register for this webinar to learn how GxP organisations can develop a sustainable AI strategy that addresses compliance risk, governance responsibilities and regulatory expectations.
Speaker
Jens Marburg, Quality Consulting Business Partner, Arithmos
Jens Marburg has more than 13 years of experience in the life sciences industry, specialising in Computerised System Validation (CSV), Computer Software Assurance (CSA), validation strategy, project management and quality frameworks. He has contributed to GAMP DACH and ISPE for more than 12 years and is a regular speaker at the GQMA Annual Conference, where he shares practical insights on compliance, digital transformation and the evolving role of artificial intelligence in GxP environments.
Message PresenterWho Should Attend?
This webinar will appeal to professionals across the life sciences industry, including:
- IT Quality professionals
- Digital Transformation and Innovation leaders
- IT and Computer Systems Managers
- Senior leaders responsible for AI initiatives
- Quality Assurance and Compliance professionals
- Professionals developing quality or compliance frameworks within life sciences organisations
What You Will Learn
Attendees will gain insight into:
- How to establish an effective and compliant AI strategy from the outset
- The key considerations before introducing AI into a GxP environment
- Common compliance risks associated with AI implementation and practical ways to address them
- Practical guidance for balancing innovation with regulatory expectations
Xtalks Partner
Arithmos
Arithmos is a consulting, technology, and services company dedicated to the Pharmaceutical, Biotech, and Medical Device companies. We specialize in guiding organizations through their digital transformation journey, helping them harness the power of technology-enabled solutions to drive efficiency, compliance, and innovation.
With a global team of industry experts, we bring deep expertise across the GxP-regulated landscape, delivering cutting-edge technologies and services in Drug Safety Pharmacovigilance, Regulatory Affairs, Clinical Development, Quality & Compliance.
At Arithmos, we bridge the gap between technology and business in the Life Sciences industry. With deep expertise in Consulting, Technology, and Managed Services, we deliver end-to-end support tailored to the unique needs of Pharmaceutical, Biotech, and Medical Device companies.
We help our clients break down operational and technological silos by:
- Efficient Communication – fostering cross-functional collaboration that accelerates decision-making and drives innovation.
- Standardized Processes – implementing harmonized, regulatory-compliant workflows that boost operational consistency and quality.
- Optimized Costs – leveraging automation, data-driven insights, and flexible service models to reduce overhead and maximize return on investment.
Arithmos acts as a strategic partner, enabling our clients to accelerate product development, ensure compliance, and improve patient outcomes.
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