QA/QC and Process Development for cGMP Manufacturing
Are you looking to better understand the challenges in developing robust processes for cell and gene therapy manufacturing? Do you have in house process development capabilities? Are you responsible for key outsourcing decisions, problem solving, or finding new solutions to reach your next milestone quickly?
Join us to hear from industry experts in an engaging panel discussion with peer-to-peer insights. Make new connections and access advice and expertise from folks who have tackled these challenges many times before.
Process Design
• Understanding robust design
• Process Development
• Scale-up and process closure/automation
• QC/release testing
Process Validation
• cGMP considerations -getting ready for compliance
• Testing methods/analytical assays
• Regulatory readiness
Customer case study
• Best practices
Who should attend?
• Cell & gene therapy manufacturing leaders
• Process development/validation leaders
• Scientific and technology transfer managers
Speakers:
Aaron Dulgar-Tulloch, Global Head of Research and Development, Cell and Gene Therapy Cytiva (formerly GE Life Sciences)
Technical business executive with experience building and managing global teams and businesses. Deep technical expertise in cell and gene therapy with demonstrated success in new product development. Experience building and operating process development services and product development businesses.
Candace Rhodes, Development Manager Cell & Gene Therapy, Cytiva (formerly GE Healthcare Lifesciences)
Candace has 10 yrs industry experience in biologics and medical device product development and production experience with a focus on cell therapy, tissue engineering, and regenerative medicine. Received her Ph.D. in Bioengineering from the University of Pittsburgh with research at the McGowan Institute for Regenerative Medicine and B.S. in Biomedical Engineering from University of Rochester. Within Cytiva, she leads the Cell & Gene Therapy Marlborough, MA FastTrak Process Development and Biology R&D team and the Eysins, Switzerland Biology R&D team.
Steven Keizer, Director Of Quality, CCRM
My professional experience up to now has focused on the technical side of science, leading to my personal realization that I should focus on leading high performance teams. I find that throughout my experiences, technical skills are teachable and easy to learn, but the human side of dealing with people, namely customers(both internal and external), regulators and leading change within organizations is my next focus area. During my career in the healthcare industry, either within the product offering (pharmaceuticals, devices, health products) or some other service provider, I have realized the impact this sector can have in the quality of peoples lives is tremendous.