Topic

Videos

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.

CAR-T and Process Validation (PDA/FDA Joint Regulatory Conference 2023)

Maik Jornitz, Principal Consultant, BioProcess Resources LLC, discusses how to upgrade facilities in an efficient manner and other highlights from his presentation.

Improving Facilities in an Efficient Manner (PDA/FDA Joint Regulatory Conference 2023)

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the importance of continuous manufacturing for the future. 

Continuous Manufacturing is Here to Stay (PDA/FDA Joint Regulatory Conference 2023)

Articles

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.

ICH Q9 R1 Hits Major Milestones for the Pharmaceutical Industry

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.

Highlights of ICH Q13 Session (PDA/FDA Joint Regulatory Conference 2023)

Leaders at CDER and CBER give update on organizational changes at FDA.

Staying Compliant in 2023

Maik Jornitz, Principal Consultant, BioProcess Resources LLC, discusses the definition of patient safety and how to implement new technologies into upgraded facilities.

The Definition of Patient Safety and Implementing Technologies (PDA/FDA Joint Regulatory Conference 2023)

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.

The Impact of Advanced Manufacturing Technology (PDA/FDA Joint Regulatory Conference 2023)

Experts discussed how to transform companies into learning organizations at the 2023 PDA/FDA Joint Regulatory Conference. 

Being Innovative in CGMP Training While Adapting to Change 

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the barriers to the development of continuous manufacturing processes after implementing ICH Q13.

Conferences