24th November 2023 | 2:00PM IST / 4:30pm CST / 8:30am GMT / 9:30am CET | Sanjay Pandey, CAR-T, QA & Regulatory lead, Immuneel Therapeutics |BOOK FREE SEAT FOR THIS WEBINAR
This presentation will outline Quality and Compliance Requirements For Cell and Gene Therapy Products which incudes:
– Facility compliance
– GMP quality Management system
– Consideration in IPQA checks and batch release procedure
– Consideration in “ Patient to product tracking system”
– Temperature-controlled clinical trial supply chain
Presented by Sanjay Pandey, CAR-T, QA & Regulatory lead, Immuneel Therapeutics
His expertise includes:
· Experience in QMS Management including QA compliance, Training Management, Internal Audit Management, Vendor Management, Change Control, Deviation, OOS Investigation. CAPA implementation, Audit compliance, IPQA and batch release activity
· Project Management: Coordination in cGMP and GLP facility setup, project design, commissioning and qualification (C & Q).
· Experience in implementation of Digitization module
· Experience in handling the audits and compliance response for biological products.
· Knowledge in regulatory operation and has successfully applied/clinical trial approval of CGT(CAR-T Cell therapy) products.
· He is experienced in regulatory interaction with Indian heath regulatory authorities i.e., RCGM, CDSCO, GTAEC and state FDA for products and regulatory consultants across the globe.