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Change Control Essentials, Truex Consultancy Essentials course

Change Control Essentials

€ 179,00 excl. VAT

€216,59 incl. 21% Dutch VAT. Business customers elsewhere in the EU with a valid VAT number pay no VAT.

Change control is the one quality system that works before something happens, which is why it is the one most often bypassed. Learn what counts as a change, how to raise one a reviewer can assess, how to scale the impact assessment, how the approval gate and implementation plan work, and how to close a change so the post-implementation review means something.

Narrated, self-paced EU GMP course · 5 lessons · 15 topics · 1 worked case · 35 check questions · 4 printable job aids · about 1 hour of core reading.

5 lessons15 narrated topics35 check questions1 h 29 min narrationCertificate
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Buying for a team? €145 per learner from 5 learners.See team licence
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Description

Deviations, complaints and recalls all deal with something that has already happened. Change control is the one system that works in the other direction, which is why it is the one most often bypassed, and why bypassing it is expensive.

What you will be able to do

  • Know what change control is for. Recognise what counts as a change, what the guidance requires, and why a planned deviation is not an option.
  • Raise a change a reviewer can assess. Describe it, classify it, and give the reviewer what they need to decide.
  • Assess the impact in proportion. Run a risk assessment scaled to the change, cover the areas Annex 15 names, and know when a change is a variation.
  • Approve it and carry it out. Use the approval gate and the implementation plan, and handle temporary and emergency changes without losing control.
  • Close it and learn from it. Verify, close, run the post-implementation review, and read what your change data tells you.

Outline

  1. What change control is — Chapter 1, 1.4(xii); Annex 15, section 11
  2. Raising a change — Annex 15, section 11
  3. Assessing the impact — Annex 15, section 11; ICH Q10, 3.2.3
  4. Approving and doing it — Annex 15, section 11
  5. Closing it — Chapter 1, 1.4(xiii); Annex 15, section 11

Then a workshop with one change worked through, a twenty-question final assessment, four printable job aids, and a short page on what to do in the next few weeks.

Who it is for

Anyone who proposes, reviews, approves or carries out changes: production, engineering, QC, warehouse, IT and QA. It assumes you work on a GMP site. It does not assume you have raised a change request before.

How the course is built

Every topic is narrated, opens with the whole argument in four lines, stops once to ask you a question, and ends with the three things to remember. Each lesson closes with a three-question check; the course closes with a twenty-question final assessment. Nothing is tested that was not taught.

What you get

  • Immediate access after payment: the course appears under your account as soon as the order is confirmed.
  • Self-paced, with your progress saved. Log in from any device.
  • Five lessons, fifteen narrated topics, one worked case, four printable job aids, the final assessment.

Price: €179 excluding VAT. VAT is added at checkout according to your country. Business customers in another EU member state with a valid VAT number are invoiced without VAT (reverse charge). A PDF invoice is sent with your order confirmation.

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