Description
Most management reviews happen on time. Far fewer change anything. The pack reassures, the slides are noted, and the same problems come back next quarter with bigger numbers.
What you will be able to do
- Say what management review is for. Explain what EU GMP and ICH Q10 ask of it, the two things it reviews, and what senior management’s part really is.
- Build a pack that tells the truth. Cover every input ICH Q10 lists, choose indicators that show what would worry you, and present trends with conclusions.
- Run a review that decides. Get the right people in the room often enough, challenge the data, and escalate urgent issues without waiting for the meeting.
- Produce outputs that change something. Decide on improvements and resources, and write minutes an inspector can rely on.
- Close the loop. Follow actions through to their effect, judge whether the quality system is suitable and effective, and be ready for inspection.
Who it is for
Site directors and senior managers who chair or attend management review, heads of QA, QC and Production, Qualified Persons, and the QA staff who prepare the pack and the minutes. It assumes you know GMP basics.
Basis
EudraLex Volume 4, Chapter 1, 1.5, 1.6, 1.10, 1.11; Chapter 2, 2.1, 2.4, 2.9; Chapter 9; ICH Q10 Pharmaceutical Quality System, sections 2 to 4.
