Sessions

Roundtable 8: With ATMPs, On-time Release is Critical to Patient Survival. How do we Design a Quality System for Today’s Products?
Roundtable 7: Patient and Public Perspectives as a Barrier to Adoption of Cell and Gene Therapies
Roundtable 6: How can Deeptech Improve Cell-therapy Precision, Turnaround Time and Yield?
Roundtable 5: Developing the Technical Workforce of the Future
Roundtable 4: Effectively Scaling Cell Therapies of the Future by Optimizing Flexible Manufacturing Practices for High-throughput Capacity and Affordable Patient Accessibility
Roundtable 3: How do we Ensure Supply Chain Challenges do not Impact Timely Delivery to Patients?
Roundtable 2: Sourcing and Regulation with your iPSC Therapeutic
Roundtable 1: Optimising CGT Processes & Tech Transfer for Manufacturing Excellence 

Roundtable 8: With ATMPs, On-time Release is Critical to Patient Survival. How do we Design a Quality System for Today’s Products?

07 Sep 2023
09:00
Upper Balcony
SPONSORED BY
CAI – Commissioning Agents Inc

Roundtable 9: With ATMPs, on-time release is critical to patient survival. How do we design a Quality System for today’s products?

Key Points: 

  • Principles of Quality Systems 
  • Application of Real time /release by exception 
  • The importance of aligning organizational design with the Quality System.
  • Designing the Quality System to match and grow with product knowledge. 

Moderated by: 

Diego Bochicchio, Director of Quality, Compliance & Regulatory EU, CAI

Katharine Dolan, European Business Development, CAI

Speakers

Diego Bochicchio
Director of Quality, Compliance & Regulatory EU
CAI – Commissioning Agents Inc
Katharine Dolan
European Business Development
CAI – Commissioning Agents Inc