Quality and Compliance Requirements For Cell and Gene Therapy Products



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.


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