MWSQA Webinar: QC vs. QA - There Can Be Only One

Presented by: Edward Armstrong

This online webinar will be given via Zoom.

21 CFR 211.22 and EudraLex Volume 4: QC vs. QA — There Can Be Only One

While organizations frequently distinguish between Quality Control (QC) and Quality Assurance (QA) as parallel functions, both 21 CFR 211.22 and EudraLex Volume 4 establish a clear regulatory expectation: there must be one independent and authoritative quality function with final decision making responsibility. This presentation examines how FDA and EU GMP regulations define quality oversight, authority, and accountability, and why attempts to "split" quality responsibilities between QC and QA often result in blurred ownership and inspection findings. Through regulatory language, inspection trends, and practical GMP examples, the session explores how different global frameworks express the same fundamental principle: quality authority cannot be duplicated, delegated away, or neutralized by organizational design. Attendees will gain clarity on how to structure, empower, and defend the single quality function required to ensure consistent product quality, data integrity, and patient protection.

Even though this event is complimentary for members, you must continue to checkout to complete your registration. After registering, you will receive further instructions on how to access the webinar via email in 1-2 business days.