PQR In development

Product Quality Review Essentials

A product quality review is the one time a year a product is looked at as a whole, not batch by batch. Most sites spend weeks compiling it and very little time reading what it says.

A short, complete course on the product quality review (PQR) as EudraLex Volume 4, Chapter 1 expects it to work: knowing what it is for and who owns it, gathering the twelve inputs, finding the trends hidden in the data, drawing conclusions with actions or written reasons, and making sure management and the Qualified Person use what it found.

Duration: 2 to 3 hours, self-paced
Level: Practitioner
Lessons: 5 lessons

Join the waitlist

This course is in development

Product Quality Review Essentials is not open for enrolment yet. Join the waitlist and we will email you when it opens. Waitlist members receive the launch price, an early look at the curriculum and a chance to tell us which situations from their own site the course should cover.

Notify me when it opens

What the course teaches and assesses

Know what a PQR is for: Explain its four objectives, how often it is done, when products may be grouped, and who does what when the manufacturer and the marketing authorisation holder are different companies.
Gather the inputs: Collect the twelve minimum items Chapter 1 lists, know where the data for each comes from, and treat each one as a question about the product.
Find the signal: Trend results, stability and complaints, judge whether the process is in a state of control, and tell normal variation from real drift.
Conclude and act: Write a conclusion for every item and for the product, decide on CAPA and revalidation with written reasons, and manage the actions to time.
Make it useful: Take the conclusions to management review, know how self-inspection and the QP use the PQR, and avoid the four common weaknesses.

Lessons

1What a PQR is
2Gathering the inputs
3Finding the signal
4Conclusions and actions
5Making the PQR useful
Scored final exam and dated certificate

What this course does and does not do

Covered

Know what a PQR is for
Find the signal
Make it useful

Not covered

Writing the PQR for your product
Statistical process control software or tool training
Regulatory variations that follow from a review

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 staff who write and coordinate PQRs
QA managers and Qualified Persons
Production, QC, regulatory and engineering

For managers

Rolling product quality review 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

EudraLex Volume 4, Chapter 1, 1.4(xiv), 1.4(xvii), 1.10, 1.11
Chapter 4, 4.29
Chapter 6
Chapter 7, 7.7
Chapter 8, 8.19
Chapter 9, 9.1
Annexes 15 and 16
ICH Q10, 2.6, 3.2.1, 3.2.4

Expected price at launch

€179

excl. VAT. Waitlist members hear first.

Product Quality Review Essentials, 5 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.

Training a team? See the Site Readiness Programme

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