9:45 – 11:15 AM Session 1: Quality Leadership — Building Inspection-Ready, Scalable Compliance Session Chair: Manoj A, Independent Consultant, Former VP & Director – Global Product Development and Engineering, Terumo Penpol Pvt Ltd.

Session Focus: How to move from “audit preparation” to quality as a leadership system. Focus on ISO 13485 alignment, CAPA discipline, supplier controls, data integrity, design controls, and creating a culture where quality accelerates speed-to-market instead of slowing it down.

9:45 – 10:00 AM S1.T1: Redefining Quality: FDA’s Alignment with ISO 13485 and Its Impact on Manufacturers [15 min]
Rupam Chaudhury, Global Business Head, Medical, Lifesciences and Healthcare, L&T Technology Services (LTTS)

10:00 – 10:15 AM S1.T2: Beyond Compliance – Quality as a Leadership System [15 min]
Sreejith Viswam, Director – Innovation Enablers (RAQA, R&D Test Lab and R&D Operations), Stryker Global Technology Center, India

10:15 – 11:15 AM S1.T3: Panel Discussion [60 min] Moderator: Manoj A, Independent Consultant

Panelists: Speakers with the additional presence of:

3. Sarada Jayakrishnan, General Manager – Quality, Terumo Penpol Pvt Ltd
4. P.S. Chandranand, PhD, WHO Prequalification Consultant; Director, Iqzyme Medtech Pvt. Ltd

5. Srihariraju Manthena, Service Delivery Manager – BSI India Regulatory Services