Warning letter addresses lack of training/education

M

melmaan2k

#21
This is one example of what one might say "SOP to death"... it is ironic that the same statement came from a person from Abbott.
 
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Stijloor

Staff member
Super Moderator
#22
an interesting side note to this thread,

There are now job openings for the Director of Quality Systems and the Manager for CAPA systems at this facility; along with Director of Complaint Handling, Manager of Complaint Investigations, and Manager of Doc control.

Looks like someone was none too pleased with the quality department after receiving that warning letter.

How about people that actually do work? ;)

Stijloor.
 
M

melmaan2k

#23
An example is one manager in Abbott was placed in position in which his skill set is not designed for. He was arguing about amount of samples in which he wants to have just 10 samples all across. He does not know what is in 21 CFR 820 which clearly states that there should be a valid statistical rationale on samples used when it comes to V&V.
Clearly he is in a wrong place.
 
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