2009

C.02.006 Interpretation 5 : GMP refresher

How can it be clearer? Human Performance Improvement (HPI… yep, training groups are progressively called HPI teams) personnel are frequently asked what is the target audience for a given course or seminar. Hey, we are quite lucky here : the regs dictate it!

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C.02.006 Well-shoed shoe-maker

Do you know the internet? Not the one we use for online shopping but the one that is full of information about compliance. I was looking through the Health Canada web site recently, looking for some inspiration for this very newsletter. Under « what’s new », I saw a document about the Quality system management and the training program for Health Canada’s investigators. Upon reading it some interesting findings were brought to my attention about the structure of their training program but also on the structure of training per se. Well, well…

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C.02.006 Interpretation 5.4 :documentation

I once participated in a discussion on LMS. Learning Management System. Another one of those systems that our IS department just loves to install… and validate! Another one of those systems everyone loves to hate. It does a great job in managing our training documentation but at what cost?

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C.02.006 Qualification

I like puzzles. Like this one : Why should a supervisor need to be a university graduate to supervise in the manufacturing area but NOT in the packaging area? The Canadian regs are pretty explicit about this. Is a danger to contaminate the product that different from one area to another? Or, more importantly, does the patient affected by a contaminated product see a difference between a product contaminated by a metal particle from the tablet press and one whose integrity was affected by a deficient storage system? What about the young lady taking a contraceptive sample, handed down by her physician after staying in the trunk of a sales rep’s car 3 days at 42? or the pre-school kid finding a nitro granule in his daily vitamin, will they ask enquire about the education level of the person responsible to supervise the operations?

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C.02.006 After all it’s all about people!

I am always flabbergasted to see the mess whenever the fundamentals are neglected. When we forget to look for the root cause of any problem, we keep having the problem or worse, it gets amplified.
Regulatory training is a requirement. The regulation imposes training on the regulation. What a superb virtuous circle!
What do we do , year after year ? We re-train. Frequently on a very similar topic. Frequently with the same results as far as compliance is concerned. Almost nothing.

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