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Audit Do's and Don'ts Essentials

When an inspector or an auditor stops at your line, your bench or your warehouse bay, you are the quality system for the next five minutes. What you say, show and do in those minutes is what they write down.

A short, practical course for the people on the floor during a regulatory GMP inspection or a customer or supplier audit: why audits happen and how auditors work, being ready every day, answering questions and showing records, the things never to do, and what to do when something goes wrong in front of the auditor.

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

This course is in development

Audit Do's and Don'ts 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

  • Understand the visit: Tell an inspection from an audit, know how inspectors and auditors work on the floor, and see that they are testing the system through you.
  • Be ready every day: Know your role, your SOPs and your training record, keep records made at the time and corrected properly, and keep your area clean, orderly and labelled.
  • Answer well: Listen, answer what was asked and stop, say "I don't know, I'll find out" when you need to, and show records exactly as they are.
  • Avoid the serious mistakes: Never alter, backdate or complete a record for the auditor, and never guess, argue, joke about quality or hide a problem.
  • Recover when something goes wrong: Acknowledge a mistake without fixing it on the spot, agree the facts of an observation, and help turn findings into lasting fixes.

Lessons

  1. 1Why audits happen and what auditors look for
  2. 2Your everyday readiness
  3. 3When the auditor talks to you
  4. 4The don'ts
  5. 5When something goes wrong
  6. Scored final exam and dated certificate

What this course does and does not do

Covered

  • Understand the visit
  • Answer well
  • Recover when something goes wrong

Not covered

  • Hosting an inspection or leading audit readiness for the site
  • Legal advice on a specific inspection or finding
  • Your site's own SOPs and records

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

  • Operators, QC analysts and warehouse staff
  • Engineers and supervisors
  • Anyone who may be questioned during an audit
For managers

Rolling audit do's and don'ts 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, 3, 4, 5, 7 and 9
  • Annex 11
  • ICH Q10
  • EU procedure on conduct of inspections

Continue the path

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Deviation Management Essentials

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

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CCFoundation
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Change Control Essentials

Raise, assess, approve, implement and close changes on a GMP site without losing control of the validated state.

5 lessons · knowledge checks · scored final exam

€179excl. VATView course