VL21CEJUN1/SES102 - Case Study Report-Outs and Discussion

Speaker(s):

• Georg SINGEWALD, PhD, SVP, Global Head Engineering, MSAT and Sustainability, Roche / Genentech

Session Leader(s):

• Frances M. Zipp, President & CEO, Lachman Consultant Services

Speaker(s):

• Carmelo Rosa, PsyD, Director, Division of Drug Quality I, FDA/CDER/OC/OMQ
• Aditi S. Thakur, Senior Pharmaceutical Quality Assessor, FDA/CDER/OPQ/OPF
• Vivianne J. Arencibia, Vice President, Global Quality Systems and Compliance, Moderna
• Mr. Antonio C. Crincoli, PE, Vice President of Global Engineering, Catalent Pharma Solutions
• David Churchward, Global Head Sterility Assurance, Cell and Gene Technologies, Lonza Biologics
• Deva H. Puranam, Head of Global Quality Investigations, Viatris
• Brooke Higgins, Senior Policy Advisor for the Global Compliance Branch 3, FDA/CDER
• José E. Meléndez, Consumer Safety Officer, FDA/ORA