Trial Oversight Spotlight #15: Matt Jones
In this episode:
In this episode, Tom and Matt discuss the evolving landscape of IT quality and validation in the pharmaceutical industry. They explore the importance of a risk-based approach to validation, the role of AI in drug development, and the need for effective vendor management and oversight. The conversation also highlights the significance of data governance and the red flags auditors should look for during inspections. Overall, the episode emphasises the shift towards quality by design and the integration of technology in compliance processes.
Key points:
- Regulators are increasingly focusing on risk-based methodologies
- Quality by design is becoming more important than traditional testing methods
- Risk assessments can significantly reduce validation efforts
- Vendor management is crucial for ensuring compliance and quality
- AI's role in pharma is growing, but it requires careful oversight
- Auditors should be wary of long bug lists and lack of transparency
- Data governance is essential, especially with the rise of AI
- Technology can streamline validation and compliance efforts
Time stamps:
- – Quality by Design Approach in GCP Revision 3
- – AI and Machine Learning Challenges in Pharma
- – Introduction to IT Vendor Validation
- – Regulatory Focus on Inspections
- – Risk-Based Frameworks for IT Vendors
- – Audit Frequency and Qualification Processes
- – Understanding Vendor Capabilities
- – Red Flags in Auditing IT Vendors
- – Actionable Takeaways for IT Quality Management
Guest Bio
Matt Jones
Chair of the RQA Board and Founder/CEO of Digital Quality Associates
Matt Jones is Chair of the RQA Board and Founder/CEO of Digital Quality Associates, bringing 25+ years of pharmaceutical leadership and cross-GxP expertise.
As an ISO 27001 lead auditor and serial technology entrepreneur, he specializes in IT compliance and computer system validation, helping life sciences organizations navigate digital transformation while maintaining regulatory compliance.
Host Bio
Tom is running the Trial Oversight Spotlight Interview Series where he meets with a variety of colleagues working in clinical research. They discuss a selection of the most important topics and decisions that are currently being navigated by all types of organisations delivering research.
Tom has spent over a decade in Clinical Trials Operations and Quality Assurance and has experienced the impact that suboptimal vendor oversight and vendor non-compliance can have on the quality of clinical trials. Mayet is the solution to fix this.