Management Review Essentials
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.
A short, complete course on management review as EU GMP and ICH Q10 expect it to work: what it is for, the inputs it needs, how to run it so it decides things, the outputs it must produce, and how to close the loop so the quality system actually improves.
Five things you will take back to site
One outcome per lesson. Each is practised in the lesson and tested at the end of it.
- Say what management review is forExplain 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 truthCover every input ICH Q10 lists, choose indicators that show what would worry you, and present trends with conclusions.
- Run a review that decidesGet the right people in the room often enough, challenge the data, and escalate urgent issues without waiting for the meeting.
- Produce outputs that change somethingDecide on improvements and resources, and write minutes an inspector can rely on.
- Close the loopFollow actions through to their effect, judge whether the quality system is suitable and effective, and be ready for inspection.
Structured so that it stays with you
Short courses are usually forgotten within a month. This one is built around the few things that are known to make material stay: hearing it as well as reading it, being asked to recall it, and meeting the same ideas again in a different form.
Narrated throughout
Every topic is narrated, so you can listen and read together, or listen alone. Hearing and reading the same material is one of the simplest ways to make it stay.
Orientation in thirty seconds
Each topic opens with the whole argument in four lines. You know where you are going before you start, which is when new material is easiest to place.
Pause and answer
Every topic stops once and asks you a question about what you have just read, with feedback either way. Recalling something is what fixes it; re-reading it is not.
Three things to remember
Each topic ends with three sentences. Not a summary of everything, but the three things you would want back in six months.
A check at the end of every lesson
Three questions per lesson, then a twenty-question final assessment. Every question is answerable from the three things to remember. Nothing is tested that was not taught.
One review, worked through
A workshop that puts a real review pack and its minutes in front of you and four decisions to make in writing, before you see how an experienced head of quality would handle it.
Five lessons, in the life of one review
Each lesson has three narrated topics and ends with a three-question knowledge check. After Lesson 5 comes the workshop, the final assessment, the job aids, and a short page on what to do before your next review.
| Lesson | Title | What it covers | Basis |
|---|---|---|---|
| 1 | What management review is for | What the guidance asks, the two reviews in ICH Q10, and senior management’s part. | Chapter 1, 1.5, 1.6; Chapter 2, 2.4; ICH Q10, 2.1, 2.6 |
| 2 | Preparing the inputs | The inputs ICH Q10 lists, performance indicators, and data that tells a story. | ICH Q10, 2.3, 3.2.4, 4.1, 4.2 |
| 3 | Running the review | Who and how often, reviewing rather than reporting, and escalation between reviews. | Chapter 2, 2.9; ICH Q10, 2.5, 3.2.4 |
| 4 | Outputs and actions | The outputs ICH Q10 expects, resources as an output, and minutes that stand up. | ICH Q10, 2.4, 3.2.4, 4.3; Chapter 1, 1.5 |
| 5 | Closing the loop | Following up actions, judging suitability and effectiveness, and management review under inspection. | ICH Q10, 2.6, 4.1; Chapter 1, 1.6; Chapter 9 |
Who this course 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.
Where it sits in EU GMP
EudraLex Volume 4, Chapter 1 asks for periodic management review with senior management involved, and Chapter 2 puts participation in it among senior management’s duties. ICH Q10, published in Part III of EudraLex Volume 4, sets out what the review should cover and produce.
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
If your management review happens on time but the same issues keep coming back, this is the course to start with.
Enrolment gives access to all five lessons, the narrated topics, the workshop, the final assessment and the printable job aids. Work through it at your own pace; your progress is saved.
