BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240328T120048Z UID:70a2efdf-3f60-49ab-81ed-80bf18644500 DTSTART:20210301T150000 DTEND:20210302T150000 CLASS:PRIVATE DESCRIPTION:
Overview
\n\nComplaint handling is li kely one of the more cross-functional parts of your quality system: Custom er Service may receive your customer complaints\, Sales and Marketing may need to reach out to the customer for additional information\, Regulatory Affairs may determine whether the complaint is reportable\, QA may perform the root cause investigation\, R&\;D or Manufacturing Engineering may need to be involved in the corrective action\, and Quality Engineering may need to trend the complaints!
\n\nThis session will include the req uirements for all of the above responsibilities\, which will include defin ing\, documenting\, and implementing a complaint-handling system\, the req uirements for complaint review\, investigation\, and corrective action\, a s well as ISO-specific implications. Also covered will be a discussion of what constitutes a complaint\, and recommended practice on how to handle & quot\;non-complaint"\; feedback. Also covered will be the application of risk management to a complaint handling system\, and a specific risk ma nagement system explained.
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\n\nObj ectives of the Presentation
\n\nUnderstand wh at FDA and ISO complaints are
\nWhat are the FDA and ISO requirements for complaints
\nWhat are the docu mentation requirements
\nWhat are the reporting requ irements
\nRequirements for a complaint system
\n \n \;
\nWhy Should you Att end
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\nMany complaints include terminology that is
unlikely to withstand an FDA or ISO audit\, such as "\;isolated occur
rence"\; and "\;low risk."\; Further\, from a business perspec
tive\, how do you let your customers know that you received their complain
t\, when you know that their next question may be the dreaded "\;What
did you find out?"\; A compliant quality system has one of its support
s\, a robust complaint system that is both compliant and business-savvy. T
his webinar will address these issues and more.
\n
\nFurther\, u
nlike many complaint management trainings\, this session'\;s streamline
d review of the regulations enables detailed focus on recommended contents
of complaint records and root cause investigations. Methods for trending
of complaints are included\, as well as form on which to document risk.
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\n\nSession Highli ghts
\n\nFDA and ISO requirements for complai nt handling
\nEstablishment of complaint handling pr ogram
\nWhat constitutes a complaint
\nHow to Handle "\;non-complaints"\;
\n \nComplaint trending and reporting
\nApplication of risk management to complaint handling program
\n < /li>\nCustomer reply: benefits\, detriments\, and recommended p ractices
\n\n \;
\nWho
will Benefit
\nThis webinar will provide valuable assistance
to all regulated companies\, since complaint handling is a regulatory req
uirement across the medical device\, diagnostic\, pharmaceutical\, and bio
logics fields. The employees who will benefit include:
Customer Service (i.e.\, your "\;complaint taker"\;)
\n li>\nRegulatory personnel
\nQuality Engin eering personnel
\nSales and Marketing personnel
\nCustomer Service personnel
\nR& amp\;D personnel
\nManufacturing Engineering
\n < /li>\nExecutive Management
\nConsultants< /p>\n
Quality system auditors
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