Events
Upcoming Events
11 December 2025
MARSQA December Lunch and Learn Webinar: AI in GxP: A Complicated Story of Laws, Regulations, and Governance Practice
Presented by: Nikodem Latocha
“AI in GxP: A Complicated Story of Laws, Regulations, and Governance Practice” is a deep dive into the complex landscape of the dynamic balance where technology confronts rigorous laws, regulations, and unique industry standards. This presentation will show the current state of global laws, including but not limited to the AI Act, technology standards, like ISO 42001 AI Management System, unique regulations in the pharmaceutical sector, combined with data protection aspects as well as ethical principles, creating a challenging homeostasis for structured AI governance programs. The presentation will also provide a unique focus on the use cases from other industries that are already successfully implementing AI systems and what the pharmaceutical industry can learn from them.
Participants will learn about:
- The European Union’s AI Act and similar laws and their implications in a highly regulated environment
- ISO42001’s AI Management System standard and its practical implementation
- AI Risk Management frameworks that balance technological advancement with patient safety, product quality, and data integrity
- Real-world case studies demonstrating successful AI governance in different industries
- Emerging compliance strategies that transform regulatory challenges into competitive advantages
- Possible ways the work of Quality personnel in pharma and biotech may change in the near future.
You’ll walk away with a strategic roadmap for responsible AI governance that meets the highest standards for safety, efficacy, and ethical considerations.
6 November 2025
MARSQA Computer Validation Committee (CVC) Roundtable - Advanced CSV Topics
The MARSQA Computer Validation Committee (CVC) will be holding an in-person CVC Roundtable at Earl’s Restaurant in Peddler’s Village, New Hope, PA, on Thursday, 6 November 2025.
Advanced Computer System Validations (CSV) topics will be discussed with more information on topics provided soon. The CVC Roundtable registration cost includes breakfast, hot buffet lunch and snacks. View the Roundtable Agenda
-->MARSQA CVC Activities
MARSQA Members, join us for these upcoming CVC activities! The MARSQA CVC has some exciting activities planned this year. For more details, or to receive meeting access information, reach out to Denise Botto at denise.botto@syneoshealth.com.
- CVC Monthly Meeting: First Tuesday of the month from 9:00-10:00 AM ET
- Reach out to Denise Botto for meeting access information.
Past Events
- 31 July 2025 MARSQA July Lunch and Learn Webinar: Hidden in Plain Sight - An Ethical Blindness Discussion
- 29 May 2025 MARSQA May Lunch and Learn Webinar: Risk-Based Approach vs. Risk Management
- 20 February 2025 MARSQA February Lunch and Learn Webinar: Risk-Based Approach vs. Risk Management
- 4 December 2024 MARSQA CVC Roundtable Event
- 24 October 2024 MARSQA Membership Meeting
- 17 October 2024 MARSQA October Lunch and Learn Webinar Series
- 16 September 2024 MARSQA and RQA Regional Forum: Explore AI, Data Integrity, and Digital Quality
- 13 June 2024 MARSQA June Lunch and Learn Webinar Series
- 23 May 2024 MARSQA May Lunch and Learn Webinar Series
- 14 May 2024 MARSQA CVC Roundtable Event
- 17 October 2023 MARSQA CVC Roundtable Event
- 14 September 2023 MARSQA Membership Meeting
- 27 July 2023
- MARSQA Lunch & Learn Webinar Series
FDA Inspection Interactions - Melissa Hochhaus and Julia Roberts - 28 June 2023
- MARSQA Lunch & Learn Webinar Series
A Crash Course on Pharmacovigilance - Larry Thomas - 18 May 2023
- MARSQA Lunch & Learn Webinar Series
FDA BIMO Sponsor Compliance Program Update - Nicole Victoria - 9 February 2023
- MARSQA Lunch & Learn Webinar Series
Cyber Security Essentials - Jason Kentner
Presented by: Melanie Willis
Presented by: Steve Gompertz
Presented by: Steve Gompertz
The Selective Deployment of AI in Healthcare - Markus Trengove
CLIA-Accredited Labs: History and Importance – Where Are We Now? - Erica Falcon
CLIA-Accredited Labs: History and Importance – Where Are We Now? - Erica Falcon
Stay tuned for future event information.