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Product Recall Essentials, Truex Consultancy Essentials course

Product Recall 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.

Much of what decides whether a recall goes well is done before it starts. Learn what a recall is and is not, how to be ready for one, how to decide whether and how far to recall in consultation with the authorities, how to run the operation, and how to close it with numbers you can defend.

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 21 min narrationCertificate
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Buying for a team? €145 per learner from 5 learners.See team licence
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Description

Much of what decides whether a recall goes well is done before it starts. On the day, there is no time to find a telephone number or discover that the distribution report takes two days to produce.

What you will be able to do

  • Recognise a recall whatever it is called. Apply a two-question test, and know what clause 8.27 means when there is no authorised alternative product.
  • Be ready before it happens. Know what the procedure, the contact list, the distribution records and the mock recall have to prove, and test them.
  • Decide, and decide how far. Choose the level on risk and distribution, in consultation with the concerned authorities, and act on incomplete information when the risk requires it.
  • Run the operation. Stop shipment first, own the log, write a notice that tells people what to do, confirm receipt, and quarantine what comes back.
  • Close it with numbers. Reconcile delivered against recovered, explain the difference, write the final report, and fix what the recall showed about your own system.

Outline

  1. What a recall is — Chapter 8, 8.20 to 8.31
  2. Being ready — Chapter 8, 8.20, 8.22 to 8.24, 8.30
  3. Deciding — Chapter 8, 8.14, 8.25 to 8.27
  4. Doing it — Chapter 8, 8.25, 8.26, 8.28, 8.29, 8.31
  5. Closing it — Chapter 8, 8.16 to 8.18, 8.29, 8.30

Then a workshop with one recall 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 could be on a recall team or could take the call that starts one: QA, supply chain, warehouse, regulatory and the Qualified Person. It assumes you work on a GMP site or for a marketing authorisation holder. It does not assume you have been through a recall.

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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