Batch Review and Release of Monoclonal Antibodies
@Biotech Training Facility
This training introduces QA professionals and Qualified Persons (QPs) to the key quality and compliance considerations involved in reviewing and releasing monoclonal antibody drug substance batches.
Location
Biotech Training Facility
Duration
0,5 day
Participants will explore the critical elements of mAb drug substance batch documentation, key quality checks and GMP requirements relevant to batch review and release. The training highlights the differences between reviewing documentation for mAb drug substance manufacturing and aseptic filling, with a focus on the responsibilities of QA reviewers and QPs in ensuring product quality, process compliance and batch release readiness.