Description
Most data integrity findings are not fraud. They are ordinary records made a little late, under the wrong login, corrected the wrong way, or reviewed on paper when the truth was in the system. This course is about those habits.
What you will be able to do
- Know what a record is, and which copy is the original. Tell an instruction from a record, find where a value was first captured, and use ALCOA++ as ten questions you can ask of any record.
- Make the entry properly. Record at the time, under your own identity, on a controlled form, with no empty fields and nothing that can be added later.
- Correct it so the original can still be read. Correct paper and electronic records the way EudraLex Volume 4, Chapter 4 and Annex 11 expect, and recognise when a correction has become a change to the result.
- Review the data, not only the printout. Check entries against their source, review the audit trail before the data is relied on, and know which record is the original in a hybrid system.
- Keep it trustworthy for as long as it must last. Keep access matched to the job, keep records restorable and readable for their retention period, and raise a data integrity problem openly when you find one.
Outline
- What a GMP record is — Chapter 4, Principle, 4.1
- Making the entry — Chapter 4, 4.7, 4.8; Annex 11, 12.4
- Correcting it — Chapter 4, 4.9; Annex 11, 9, 12.4
- Reviewing it — Annex 11, 6, 8, 9
- Keeping it — Chapter 4, 4.10, 4.11; Annex 11, 7, 12, 13, 17
Then a workshop with one laboratory result reviewed properly, 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 makes, checks, reviews or approves a GMP record, on paper or in a computerised system: production, QC laboratory, engineering, warehouse and QA. It assumes you work on a GMP site. It does not assume you know anything about computerised systems.
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, seventeen 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.
