The second commandment : procedures you shall respect
Once the procedures are written up, a lot of them end up on a shelf or in a binder in a supervisor’s desk. Under lock and key! TOO FREQUENTLY ! And too frequently, this is observed by…
The first commandment : procedures you shall write
DEATH BY SOP ! Sometimes I think that the FDA, HPFBI, MCA and WHO all have that in mind when they ask to see our procedures !
Blocages! Partie 1
Nos organisations bloquent la créativité! Certains de ces blocages son connus. D'autres moins. Première partie d'une série sur les blocages à la créativité.
Étapes vers la créativité : la préparation
Tout le monde est créatif. Mais pas toujours au bon moment. La première étape vers le contrôle de VOTRE créativité : La préparation à la créativité.
Le nerf de la guerre …Cash-cash sans cachette!
Votre plan stratégique doit s’appuyer sur des partenariats stratégiques à l’interne. Qui seront ces partenaires? Depuis quand entretenez-vous ces partenariats? Prenez-vous le temps de discuter de…
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…
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…
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…
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…
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.…
The tenth commandment : You shall be in compliance
Research ,Discipline, Reviewing because you, dear readers, request it.
The Ninth Commandment : You Shall Control Quality
We do talk a lot about quality when pharmaceuticals are involved. Quality control, quality assurance (oh, by the way the latter does not exist in the Canadian regulation...
The Eighth Commandment : You Shall Be Clean
In our increasingly aseptic world, it is natural to expect a pharmaceutical company to be clean. Extra clean. Totally clean. Our dishwasher soap contains antibacterial agents, our handwhashing soap…
The Seventh Commandment : Competence (Training, Education an Experience) You Shall Have
Nobody will argue that Tiger is a great golfer. And he tees-off perfectly. TEEing-off perfectly is the way to start a great golf game. Receiving the right Training, Education and Experience is,…