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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

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, with licences from ten seats
  • 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

Continue the path

DEVPractitioner
Founding list open3 hours, self-paced

Deviation Management Essentials

Detect, document, investigate and close deviations the way inspectors expect to see them, with clear ownership and defensible impact assessments.

6 lessons · knowledge checks · scored final exam

CCPractitioner
Founding list open2.5 hours, self-paced

Change Control Essentials

Plan, assess, approve and verify changes to facilities, equipment, materials, processes and systems without losing control of the validated state.

6 lessons · knowledge checks · scored final exam