Autumn 2007
A Week in Cork on a Pharma IT Course
An indication that a training course you have attended was a good one is that on your return to the office you voluntarily put into practice, on a regular basis, what you have learned. I’ve been in Pharma now for 30 years and attended many good and indifferent courses run internally and externally and I have to say that the Pharma IT course, organised by Regulatory Compliance Workshop Group (RCWG), held in Ireland during July of this year was one of the better ones
Sandwiched between a ten hour round trip from Norwich to Cork, which included sampling the delights of Dublin airport (for those of you who enjoy the hustle and bustle of the January sales this is the place for you), was a five-day workshop led solely by Dr Bob McDowall. Each day was a distinct module and so attendees differed from day-to-day with a just a few of us hardy soles staying the course for the entirety.

Bob himself has an impressive CV for this sort of thing and whilst his forte was within GLP, in particular LIMS and Spectroscopy, the numerous articles (>250 papers and book chapters), committees, time working in Pharma coupled with fourteen years consulting experience, over 20 years experience in computer validation and 500 presentations at symposia and meetings provided evidence that he knew his subject across GxP in general and this was certainly borne out during the week.

Day 1 started very Monday morningish with little response from the attendees to the request to show a bit of enthusiasm but as the week wore on so the signs of life became more apparent. Friday was euphoric!
The course itself was a nice blend of lectures and workshop tasks punctuated by a number of interesting facts such as equating the length of time to test all possible aspects of a relatively simple program to the geological age of the earth.
Of the five days, the Records Based Approach To Validation on day 3 and Auditing Computerised Systems to Pass Regulatory Inspections on day 5 would probably rate highest for me. Day 3 was good because I like the idea of focusing not on the system(s) and the process(es) but on the records themselves. This effectively turns the traditional approach to validation on its head and works back from the records to the system functionality; the argument in favour of this approach being that records are more important and last longer than the systems that generate them. The records based approach places the emphasis on identification of records and signature requirements covered by predicate rules and an assessment of the impact of those on product quality, patient safety, or regulatory submission.
The five days covered the following topics:
Day 1
Software (User Acceptance) Testing of Computerised Systems in EU and FDA Regulated Environments
Day 2
Meeting EU and FDA Regulatory Requirements for Change Control and Configuration Management
Day 3
Records Based Approach to Software Validation
Day 4
Understanding and Applying Risk Management to Meet FDA’s Expectations for Computerised Systems
Day 5
Auditing Computerised Systems to Pass Regulatory Inspections

In focusing on the records it is essential to have a good understanding and interpretation of predicate rule requirements, this being critical to the success of any validation. Day 5 was good for me personally, simply because auditing is an area that I would like to eventually get into and I found this particular module a useful insight to this subject.

Attendees were given the chance to review validation documentation and auditor’s observations together with some interesting photographs of a communications room and computer room taken during an audit – made my house look tidy anyway!
Day 4 covering Risk Management was again very useful for anyone wanting to cut down on the amount of validation work (don’t we all!) – properly conducted risk assessments are an essential way to justify a reduction in the amount of validation and this training module described several different methodologies that are available for conducting a risk analysis.
For those of you involved with User Acceptance Testing, Day 1 covered all of the essentials including the need for well formed requirements, how to write good test documentation and the reasons why people can at times find UAT so difficult to execute. This was supplemented with a look at the Homer Simpson test. For anyone as naïve as me don’t rush to Google it – this was actually referring to the Homer Simpson from the Simpsons TV programme. Attendees were presented with a number of requirements and asked to evaluate their testability; for those that were written in such a way as to make them difficult to define a test for, the catchphrase D’oh (which apparently now features in The Oxford English Dictionary) had to be placed alongside.
Day 2 focused on Change Control and Configuration management with the key message being that effective Change Management is the single most important factor in maintaining validated status. An extract from an FDA 483 warning was provided, as an example of a company that had failed to document the significance of changes and the potential impact on a system had not been evaluated.
The course information consisted some 500 slides, hard copy ring binders and CDs. Having trawled through the CDs there is a large core of general information replicated on each together with specific material related to the topic for the day. The core information includes many good references and extracts from regulations that I found to be very useful.
So, in summary I would definitely recommend future courses organised by RCWG and in particular those led by Bob McDowall.
David Bishop
Clinical IS Quality & Compliance Specialist, AstraZeneca
Further information about RCWG and the courses they are running is available from www.rcwg.org. Dr Bob McDowall can be contacted at www.rdmcdowall.com