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Complaints Essentials, Truex Consultancy Essentials course

Complaints 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.

A complaint is different from every other quality record: the product is already out of your control, and the person holding it may be a patient. Learn to take the complaint properly, decide whether it is a quality defect, investigate backwards from an effect somebody else noticed, notify the right people in time, and learn from what the customer found before you did.

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

A complaint is different from every other quality record you will meet, for one reason: the product is already out of your control. Someone else has it, and they may be a patient.

What you will be able to do

  • Know what a complaint is and who owns it. Recognise a quality complaint, keep it independent of sales, and get it into a system that acts without delay.
  • Take it so that it can be investigated. Capture the first record properly, because everything that follows is linked back to it.
  • Decide whether it is a quality defect. Apply a four-question test, decide on risk, and act to reduce risk before all the facts are in when clause 8.14 requires it.
  • Investigate backwards. Work from an effect the customer saw to a cause on your site, months after the batch was made, using retained samples and batch records.
  • Close, reply and learn. Reply to the customer, notify the marketing authorisation holder and authorities where required, and trend complaints so the system improves.

Outline

  1. What a complaint is — Chapter 8, 8.1 to 8.5, 8.7
  2. Taking the complaint — Chapter 8, 8.5, 8.12
  3. Is it a quality defect? — Chapter 8, 8.1, 8.5, 8.13 to 8.15
  4. Investigating — Chapter 8, 8.12, 8.16 to 8.18
  5. Closing and learning — Chapter 8, 8.1, 8.12, 8.19

Then a workshop with one complaint 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 might take a complaint call, log a complaint, investigate one, or sign one off: customer service, QC, production and QA. It assumes you work on a GMP site or for a marketing authorisation holder.

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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