Description
Most deviation systems fail at the front, not at the back. The investigations are usually competent. The problem is what goes into the system, how it is classified, and how it is closed.
What you will be able to do
- Recognise a deviation when you see one. Tell the difference between a deviation, a planned change and an out-of-specification result, and know what belongs in the system and what does not.
- Raise it properly in the first hour. Write a description that a stranger could investigate from, preserve the evidence, and contain the product before anything else.
- Classify it on the evidence. Use a tiered classification that reflects risk to the product and the patient, and be able to defend the tier you chose to an inspector.
- Separate cause from product impact. Answer why it happened and what it means for the batch as two different questions, with the Qualified Person told at the right time.
- Close it so the record stands. Verify the actions, close on time, and read what your own deviation data is telling you about the site.
Outline
- What a deviation is — Chapter 1, 1.8(vii), 1.4(xiv); Chapter 5, 5.15
- Raising it properly — Chapter 1, 1.4(xiv); Chapter 5, 5.15
- Classification — Chapter 1, 1.8(vii)
- Investigating and assessing impact — Chapter 1, 1.4(xiv), 1.9(vii)
- Closing it — Chapter 1, 1.5, 1.8(vii)
Then a workshop with one deviation 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 raise, investigate, review or approve a deviation: production, QC, engineering, warehouse and QA. It assumes you work on a GMP site. It does not assume you have written an investigation 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.
- Final assessment of 20 questions, 80% to pass, three attempts.
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.
