In December, I attended my absolute favourite GMP event of the year, the Medicines & Healthcare products Regulatory Agency (United Kingdom) (MHRA) GDP / GMP symposium in London, aside from having the opportunity to drop into our London office and meet local team of GMP experts. I was once again had an opportunity to attend a Data Integrity Training Course, the current industry hot topic, presented by David Churchward. David is arguably the world’s leading thought leader in this area, having a significant hand in the MHRA’s original Data Integrity guidance which has led to further guidances to be issued by the MHRA, US FDA, WHO, PIC/S and most recently CFDA. David is an expert GMDP Inspector with the Medicines & Healthcare products Regulatory Agency (United Kingdom), and regularly represents the MHRA on a national and international level, in order to develop technical and legislative positions relating to GMDP inspections.
As an organisation, we are particularly interested David’s training, especially knowing that he had a hand in the development of the draft PIC/S Data Integrity guidance. And feeling jaded from attending what feels like a Data Integrity training course on every continent, we have gleaned the best of the best from US FDA, TGA, MHRA inspectors and industry experts. We have distilled the essential features into a must know Data Integrity Training Course. As we all know, Data Integrity issues are not the exclusive domain of the pharmaceutical industry, we only have to look at my previous Qantas and Volkswagen blogs, so we have looked outside of our industry for lessons, and found many.
As an appetiser, in previous blogs we have discussed the human factors: the Motive, Opportunity and Means (MOM) and the almost overused acronym ALOCA, and more recently the ALOCA + thinking. But its not just the international training we have been tracking; we have been carefully monitoring inspection finding by the MHRA, US FDA and TGA to look for common issues. After presenting at a PDA event last year, titled Success by Design Fat-finger, Falsification and Fraud and running numerous training courses nationally and internationally, we have been enhancing our data integrity training course into this “must know” data integrity training course.
We have designed and built an interactive, action packed, one day course on the DI pitfalls to avoid, taking in consideration the human factors in document design and IT system form design and the monitoring of these systems.
GMP / GDP Update
A little more about the MHRA Symposium in London: some of the major announcements were that the EU are planning to withdraw the GMPs Annex 2 and 13. At this stage, neither will have a direct impact in Australia or the PIC/S member countries in the short term, and will not impact PIC/S PE009-13. PIC/S PE009-13 was released on 1st January 2017 and from public statements, the TGA plan to adopt this revision sometime in 2017.
Andrew Hopkins, the Head of the EMA inspectors working group and PIC/S committee coordinating the Annex I revision reported that the first draft of Annex 1 might be available for public comment at the end of Q1 2017.
There has been a significant gap between current Australian GMP and EU GMP. I have been thankful that the Chapter 3 and 5 updates around cross-contamination were not immediately adopted in Australia. It appears that the regulators have reached a more pragmatic view on determining toxicology data for compounds and now reserved for only only highly potent compounds. The MHRA have expressed their view on this threshold.
Outlook for 2017
PharmOut works hard to bring innovative, fresh thinking to old problems. We have full training program in 2017 and using cutting edge technology, our training courses are going paperless and are fully validated. What this means is that your training materials will be online and all you need is to Bring Your Own Device (BYOD). At the end of the session, the trainee simply emails the training materials and notes to themselves. Course training assessments will be via our innovative paperless / online quiz system and your certificate will be emailed to you at the completion of the course.
The above system connects to our SharePoint EDMS solution provided by QikSolve to maintain indelible records in PharmOut’s validated SharePoint solution designed with Data Integrity in mind.
What this means is that with this delivery platform we have reduced our 2017 training prices by 25%, why not attend one of our Data Integrity Training Courses?