What is the trigger for the industry to adopt newer guidelines/concepts/systems?

v9991

Trusted Information Resource
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.:frust:

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!!!
 

Stijloor

Leader
Super Moderator
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.:frust:

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!!!

Comments anyone?

Thanks!!

Stijloor.
 
A

adickerson

I am an outsider to the FDA system but it seems that most companies that take safety seriously already know what to do. They chose not to because it is cheaper to deal with fines then address the issues.
 
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