Does the industry wait for the regulators to come out with new guidance/systems? (regulations are anyways enforced right!!! )
Even after these guidance are published, is the industry waiting for inspections/audits from agencies; or waiting to see warning letters on subject matter.
Worst part is that, even organizations/experts who have already learned the trick (implemented the systems) are silent about it...
here's a example...
I may be really a beginner in searching internet; but there is NO PRACTICAL information on implementation of new process validation guideline.
Neither is there any way to check your approach!!!
Even after these guidance are published, is the industry waiting for inspections/audits from agencies; or waiting to see warning letters on subject matter.
Worst part is that, even organizations/experts who have already learned the trick (implemented the systems) are silent about it...
here's a example...
I may be really a beginner in searching internet; but there is NO PRACTICAL information on implementation of new process validation guideline.
Neither is there any way to check your approach!!!