# Navigating Regulatory Expectations for QA in CGT Manufacturing \- C3i

**URL:** [View](https://centrec3i.com/en/webinar/navigating-regulatory-expectations-for-qa-in-cgt-manufacturing/)

**Last Updated:** 2026-08-07T20:19:10+00:00

**Other languages:** [Français](https://centrec3i.com/webinar/comprendre-les-exigences-reglementaires-en-matiere-dassurance-qualite-dans-la-fabrication-des-therapies-cellulaires-et-geniques/)

The rapidly evolving field of cell and gene therapy (CGT) presents unique scientific and operational challenges, alongside increasingly rigorous regulatory expectations.
This webinar provides a structured overview of the current global regulatory landscape, highlighting key guidance from the FDA, EMA, and Health Canada, and outlining how these expectations differ from those applied to traditional pharmaceuticals.
Participants will gain insight into the critical quality assurance requirements specific to CGT manufacturing, including the control of highly variable biological starting materials, robust management of complex and sensitive processes, contamination prevention strategies, and approaches to lot release within accelerated production timelines.
Additional focus will be placed on data integrity and the operational requirements associated with maintaining the chain of identity and the chain of custody throughout the vein‑to‑vein lifecycle. The session will also cover best practices for preparing for regulatory inspections.

**Video:** https://youtu.be/kqeLth4AVt0