RECFounding list open

Product Recall Essentials

Decide when a defect needs a recall, notify the competent authority, execute the recall and reconcile what came back against what was distributed.

Duration: 2 hours, self-paced
Level: Practitioner
Lessons: 6 lessons

Do I really need this course? See a sample lesson

What the course teaches and assesses

Describe the decision points between a quality defect and a recall
Identify who must be notified, and in what order
Follow a recall through to reconciliation of distributed stock
Explain recall classification and why the class drives the urgency
Run a mock recall that tests the system rather than the paperwork

Lessons

1When a quality defect becomes a recall
2Recall classification and urgency
3Notifying competent authorities and the Rapid Alert system
4Executing a recall across the distribution chain
5Reconciling returns against what was distributed
6Mock recalls and proving the system works
Scored final exam and dated certificate

What this course does and does not do

Covered

Recall decision making and classification
Notifying competent authorities and managing the recall
Reconciliation of distributed stock and mock recalls

Not covered

Making a recall decision for your product, which rests with your QP and management
Your recall procedure, distribution records or wholesaler contracts
Non-EU recall obligations in other jurisdictions

This course is professional training. It does not replace your site’s procedures, and it is not regulatory or legal advice on a specific event.

Who it is for

QA management
QPs and regulatory affairs

Before you decide

Do you really need this course?

10 questions from real inspection findings. Three minutes. No sign-up.

Not started

Ten questions about whether a recall would actually work at your site, written from the Chapter 8 deficiencies inspectors cite most. Nobody sees your answers.

For managers

Rolling product recall essentials out to a team?

The Site Readiness Programme adds a team heatmap from the self-assessment, a live session on the weakest questions, and records named by employee ID. Quote within two working days.

Seats for the whole team, with licences from ten seats
Anonymised team heatmap: which questions your people fail, by chapter
90-minute live session built on the team's weakest questions

See the programme

Regulations referenced

EU GMP Chapter 8
EU GMP Annex 16
EMA guidance on Rapid Alerts

Founding price held until 30 December 2026

Per learner

€199

Product Recall Essentials, 6 lessons, knowledge checks, 12 months access · €199
Worked examples and knowledge checksEvery lesson runs on a real situation, with checks that ask you to make the call rather than recall a definition.
Template packThe report, assessment and investigation templates from the free resources, annotated with what a reviewer looks for in each field.
Before-and-after readiness scoreRetake the self-assessment after the course. Keep both scores as evidence of the gap you closed.
12 months of access, with author Q&AIncluding any updates made during that period. Ask the course author about your own deviations, changes and records.
Dated certificateNames the learner, the course and the exam result, with a unique ID any employer or auditor can check. Supports the training records EudraLex Volume 4 Chapter 2 expects you to keep.

Still under 75% on the retake? Tell us.

Finish the course and retake the chapter assessment. If you still score under 75%, email us with the questions you missed. We will point you at the material that covers them, and if it is quicker to talk it through, we will arrange a call.

Reserve the founding price

Opens truex-consultancy.com, where the course is delivered. Not open for enrolment yet: the founding list holds €199 until launch.

See a sample lesson

Training a team? See the Site Readiness Programme