CMPOpen for enrolment

Complaints Essentials

Take a complaint in, record it so it can be investigated, judge whether it signals a quality defect, and close it with a conclusion that holds.

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

Enrol: €179 + VAT See a sample lesson Do I really need this course?

What the course teaches and assesses

Record a complaint so that someone else can investigate it later
Separate a dissatisfaction from a suspected quality defect
Decide when a complaint must be escalated, and to whom
Investigate a complaint against batch and distribution evidence
Trend complaints so a pattern is visible before a regulator finds it

Lessons

1Complaint intake, recording and classification
2Dissatisfaction or quality defect: making the call
3Investigating a quality defect properly
4Escalation, notification and who needs to know
5Closing a complaint with a defensible conclusion
6Trending complaints into CAPA
Scored final exam and dated certificate

What this course does and does not do

Covered

Intake, recording, classification and acknowledgement
Investigating a suspected quality defect
Escalation criteria, closure and trending into CAPA

Not covered

Pharmacovigilance and adverse event reporting, which is a separate obligation
Your complaint handling procedure or CRM system
Deciding whether to recall, which is covered in Product Recall Essentials

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 and complaint handlers
Customer-facing quality staff

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 what happens between a complaint arriving and a conclusion being written. Taken from the Chapter 8 deficiencies inspectors cite most. Nobody sees your answers.

For managers

Rolling complaints 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, priced per learner from 5 learners
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
ICH Q10 Section 3.2.2
EU GMP Annex 16

Per learner

€179

excl. VAT · €216.59 incl. 21% Dutch VAT

Enrol now: €179 + VAT

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Complaints Essentials, 6 lessons, knowledge checks, 12 months access · €179
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.

Buying for a team?

€145 per learner excl. VAT, from 5 learners. You add your learners yourself and follow their progress.

Team licence

See a sample lesson

Training a team? See the Site Readiness Programme