Bhupinder,
The 'grey' area in regulatory affairs is what keeps us in our jobs haha. Not to make this too lengthy as there can be many discussions around this, and level of regulatory compliance, but the main aspect goes to the amount of regulatory risk an organisation is willing to accept.
When dealing with grey areas of regulations, interpretations one way or other, or industry practices. Your idea of previous examples is good as this coincides with how industry manages activities as you can get "best practices" from different regulatory aspects.
I like to think of a regulatory or quality persons role as a navigator on a boat telling the Captain ways to steer the boat. Taking large regulatory risk is going through a tough and maybe non-navigated path versus low regulatory risk is advising the Captain to take a slow, cautious way down the river. Every company has different appetites of regulatory risk from small entrepreneur start ups usually take large regulatory risk whereas large mature organisation may take smaller regulatory risk. When navigating the grey area there can be multiple interpretations of regulations which depends on the level of compliance an organisation may take.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 03-Nov-2019 10:40
From: Bhupinder Singh
Subject: Navigating the Grey Area
Hello RAPS Community,
Could you please advise on how to navigate the Grey area in Regulatory compliance? I used the below approach:
1) Used previous examples, if any
2) Use facts, citations, references
Thanks,
Bhupinder Singh
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Bhupinder Singh
QA/RA Manager (RAC)
San Jose CA
United States
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