CSV and IT Compliance Training

CSV and IT Compliance Training

“We have just concluded several regional training sessions with Sion Wyn on IT compliance and Computer System Validation for the drug, device and vet industries. The course curriculum was developed with industry representatives to incorporate current issues and perceived looming mega trends; providing a real world view for the next 2 years.

While developing the course, it was apparent that most Australian companies were familiar with GAMP 5 fundamentals and Computer Systems Validation principles. However, we often forget that unless we set logical constraints, global computer systems do not recognise international borders, and so recent changes to the EU and US FDA GMPs directly impact these systems.

For this reason, we focussed on the IT impact of updates in Chapter 4 and Chapter 7 of the EMEA GMP and of course, Annex 11, which we workshopped extensively. Most of our trainees had a solid understanding of Annex 11, so we also spent some time anticipating possible tripping points in Annex 11. As you can probably guess, these tripping points included risk assessments, supplier qualification and maintaining a current URS through the system’s lifecycle. We addressed the number 1 concern, risk assessment, by asking the trainees to develop a SOP on IT system risk assessments; the input from each course has been collated by the PharmOut’s Debbie Parker and Ilona Pillai, and a draft is available online to the course attendees.

The last afternoon was the fun part of the course, where we discussed Apps (whether they were devices or IT systems), Cloud computing, Virtualisation and of course, the Windows 8 / Apple / Android operating systems were hotly discussed at tea time.

It was a privilege to have someone of Sion’s calibre to lead us through the learning, offering practical, sensible advice on current and future issues.”

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