To successfully increase speed-to-market for gene therapies, having a defined CQV (Commissioning, Qualification, and Validation) strategy is critical to project success. In this webinar co-sponsored by Precision ADVANCE and Project Farma, our panel of industry experts discuss tips for delivering efficient, reliable, GMP-compliant facilities and processes specific to gene therapy.
This webinar hosted by Endpoints Webinars and co-sponsored by Precision ADVANCE and Project Farma will be moderated by Michelle Sinsel (Director, Project Farma), and feature insights from James Burback (Gene Therapy Program Manager), Joe Neroni (Director, Project Farma), Tina Parikh (Head of Quality Assurance, Neurogene), Kirsten Pier (VP of Process Development & Manufacturing, Sio Gene Therapies), and Terrell Smith (Director, Project Farma).
Attendees will have the opportunity to learn:
- Key factors for assembling an experienced and flexible team
- The importance of process knowledge, including equipment and design
- Quality-by-design principles and GAMP guidelines
- About automation, emerging bioreactor, single use, and disposable technologies
- How to optimize speed-to-market by applying innovative COTS strategies, vendor documentation, out of place commissioning, and more
- Tips for navigating the regulatory landscape