BRR In development

Batch Record Review and Release Essentials

A batch record is the only evidence that a batch was made as approved. If it is not in the record, then for the Qualified Person it did not happen.

A short, complete course on the life of one batch record as EudraLex Volume 4 expects it: what the record must hold, how to review it as evidence, how to link every deviation, out of specification result and change to the batch, what the Qualified Person must be able to rely on, and how certification and release actually happen.

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

Join the waitlist

This course is in development

Batch Record Review and Release 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 the record must hold: Check a batch processing record and a batch packaging record against the content lists in Chapter 4, made at the time, whether they are on paper, electronic or both.
Review it as evidence: Read every entry, correction and signature, recalculate yields and reconciliations against their limits, and confirm line clearance and in-process controls were done and recorded.
Link every event to its investigation: Match deviations to the record both ways, judge whether an invalidated out of specification result has a real cause, and recognise when Annex 16, section 3 applies.
Support the Qualified Person: Read Annex 16, 1.7 in plain language, check materials and the supply chain against the marketing authorisation, and know where the review ends and certification begins.
Handle release in practice: Tell certification from release, hold a batch that is not ready, record the decision, and trend review findings so the same error stops coming back.

Lessons

1What a batch record is
2Reviewing production records
3Deviations, OOS and changes in the record
4What the QP must confirm
5Release in practice
Scored final exam and dated certificate

What this course does and does not do

Covered

Know what the record must hold
Link every event to its investigation
Handle release in practice

Not covered

Qualified Person qualification or certification decisions
Your site's batch record templates or electronic batch record system
Reviewing a specific batch on your behalf

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 batch record reviewers
Production supervisors and QC reviewers
Staff who support the Qualified Person

For managers

Rolling batch record review and release 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, Chapters 1, 2, 4, 5 and 6
Annex 11
Annex 15, 5.29
Annex 16
ICH Q10 (EudraLex Volume 4, Part III)

Expected price at launch

€179

excl. VAT. Waitlist members hear first.

Batch Record Review and Release 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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