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SOPs and Internal Audit Criteria for Regulatory Affairs (Submissions Function)

v9991

Trusted Information Resource
#1
1) what kind of SOPs are implemented for RA function?
2) what are the objectives/compliance-targets covered in internal audit?
3) what are the common NCs observed in the audit?
 
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Marc

Fully vaccinated are you?
Staff member
Admin
#2
A last quick "Bump" - My Thanks in advance to anyone who can help with this one.
 

v9991

Trusted Information Resource
#3
may be the query is posted in incorrect forum!!!
i am sure i didn;t ask anything too complicated!!!
 

yodon

Staff member
Super Moderator
#4
I'll give it a go and maybe get the ball rolling.

Maybe one thing is that the role of RA may not be exactly the same throughout industry. What I would expect to be typical activities would include:

Managing submittals (so this pulls in doc control - both USING controlled documentation; e.g., references and control of their own docs; e.g., signatures, storage, etc.)
Managing regulatory aspects of complaints / adverse events (so there's probably SOPs for handling these matters)

So in terms of what would be assessed in an internal audit, you'd have to know what the responsibilities are and what (internal) procedures govern their activities.

Don't know if this helps but maybe it will at least spur discussion.
 
S

selena15

#5
Hi all
long time ago :(

interesting topic,
i would assume that it depend, if it is legal issues such dispute and litigation, you may assess it versus the regulations for such subject and the jurisprendence cases to see if any deviation had occured and so one,
if it is for bribes and corruption issues, you may assess it versus the sox regulations and relating to.
somme comments?
selena
 
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