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October 12, 2023
Humberto Vega, PhD, Executive Director, Bristol Myers Squibb, discusses the journey from clinical to commercial cell therapies as a part of his session, "Successfully Navigating Global Cell Therapy Requirements."
October 11, 2023
Bassem Gayed, PhD, Senior Technical Director of CAR-T Process Engineering, Manufacturing Science & Technology at Bristol Myers Squibb, discusses the importance of CAR-T as a modality.
October 10, 2023
Bassem Gayed, PhD, Senior Technical Director of CAR-T Process Engineering, Manufacturing Science & Technology at Bristol Myers Squibb, discusses the connection of process validation and CAR-T processes.
September 21, 2023
Maik Jornitz, Principal Consultant, BioProcess Resources LLC, discusses how to upgrade facilities in an efficient manner and other highlights from his presentation.
September 20, 2023
Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the importance of continuous manufacturing for the future.
As for the topic of subjectivity, Viehmann said how high levels of subjectivity in risk assessments and in QRM are problematic and are not aligned with the 1st QRM principle of Q9.
Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the highlights of her ICH Q13 session that she wants others to be aware of.
Leaders at CDER and CBER give update on organizational changes at FDA.
September 19, 2023
Maik Jornitz, Principal Consultant, BioProcess Resources LLC, discusses the definition of patient safety and how to implement new technologies into upgraded facilities.
Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses how advanced manufacturing technology can improve things such as cost and efficiency.