BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240329T133551Z UID:25131278-652e-487a-9267-2eb601138096 DTSTART:20211011T130000 DTEND:20211012T130000 CLASS:PRIVATE DESCRIPTION:
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FDA requirements for complaint handling
\n&bull\; \; \;  
\;Establishment of complaint handling program
\n&bull\; \; \;
 \;What constitutes a complaint
\n&bull\; \; \;  \;W
hat constitutes an MDR event
\n&bull\; \; \;  \;Evaluatio
n of feedback as MDR: gray areas
\n&bull\; \; \;  \;The r
oles of investigation and corrective action in complaint handling
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bull\; \; \;  \;Complaint trending and reporting
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; \; \;  \;Application of risk management to complaint handlin
g program
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\n\nThis we
binar will provide valuable assistance to all companies that market in the
U.S.\, since they are by definition subject to FDA regulation\, in the Me
dical Device\, Diagnostic\, Pharmaceutical\, and Biologics fields. The emp
loyees who will benefit include:
\n&bull\; \; \;  \;Execu
tive/senior management
\n&bull\; \; \;  \;Regulatory mana
gement
\n&bull\; \; \;  \;QA management
\n&bull\;&nb
sp\; \;  \;Any personnel who may have direct interaction with FDA
officials
\n&bull\; \; \;  \;Consultants
\n&bull\;&n
bsp\; \;  \;Quality system auditors
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