SI In development

Self-Inspection Essentials

Self-inspection is the one audit a site controls completely: who does it, when, how deep it goes and what it does with the answers. Most sites use very little of that control.

A short, complete course on self-inspection as EudraLex Volume 4, Chapter 9 expects it to work: building a programme that covers everything, preparing each audit from the records, conducting it on the floor and through the documents, writing and grading findings that stand up, and following them through until the fix is shown to work.

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

Join the waitlist

This course is in development

Self-Inspection 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

Build the programme: Cover every area Chapter 9 lists, at a frequency set on risk, with auditors who are independent and competent.
Prepare each audit: Write a plan, read what the quality system already knows about the area, and use a checklist without letting it limit you.
Conduct it well: Follow the material, watch real work, follow trails through the records, and gather objective evidence by asking open questions.
Report findings that stand up: Write findings someone who was not there can understand, grade them on the scale inspectors use, and issue an honest report.
Follow through: Turn findings into actions that address the cause, close them only when they work, and trend results for management review.

Lessons

1The self-inspection programme
2Preparing a self-inspection
3Conducting it
4Findings and the report
5Follow-up and learning
Scored final exam and dated certificate

What this course does and does not do

Covered

Build the programme
Conduct it well
Follow through

Not covered

Carrying out your self-inspections for you
Your site's self-inspection procedure or audit software
Lead auditor certification

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 auditors and trained auditors
Owners of the self-inspection programme
Heads of department who receive findings

For managers

Rolling self-inspection 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 9
Chapter 1, 1.4(xiv), 1.4(xvii), 1.11
Chapter 2, 2.9
Chapter 4
ICH Q10, 4.1
EU procedure on conduct of inspections

Expected price at launch

€179

excl. VAT. Waitlist members hear first.

Self-Inspection 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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