This two‑day virtual event delivers a focused exploration of the Quality Aspects of the Potency CQA for biopharmaceuticals. As regulators intensify scrutiny on potency as a core indicator of product’s functional performance, this conference highlights how CMC strategy, analytical rigor, and strong QA oversight come together to ensure potency methods are scientifically justified, phase‑appropriate, and inspection‑ready.

Attendees will gain practical insights into potency assay design, validation, lifecycle management, statistical approaches, reference standards, comparability, and global regulatory expectations. Special emphasis is placed on the QA function as the steward of potency governance, ensuring robust documentation, data integrity, deviation management, and defensible decisionmaking across diverse biopharmaceutical modalities.

Designed for CMC, QA/QC, Analytical Development, Regulatory Affairs, and Technical Operations professionals, this event equips teams to build potency programs that are fit‑for‑purpose, compliant, and resilient across the product lifecycle.