AUD In development

Audit and Inspection Readiness

How to prepare people, documents and the site for internal audits and regulatory inspections, and how to behave in the room.

Duration: 2 hours
Level: Advanced
Lessons: 6 lessons

Join the waitlist Do I really need this course?

This course is being written now

Audit and Inspection Readiness is in development. 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.

What this course does and does not do

Covered

How inspections are planned and what is usually requested first
Preparing people, documents and the site
Conduct in the room and responding to findings

Not covered

Representing you during an inspection
Reviewing or writing your response to a specific observation
Certification or accreditation of any kind

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
Subject matter experts

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 how ready your site is for an unannounced inspection tomorrow morning. Written from the self-inspection and inspection conduct deficiencies regulators cite. Nobody sees your answers.

For managers

Rolling audit and inspection readiness 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 9
EMA GMP/GDP Inspectors Working Group Q&A

Price at launch

TBC

Audit and Inspection Readiness, 6 lessons, knowledge checks, 12 months access
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