Complaint Handling in Compliance with FDA and ISO Regulations by globalcompliancepane


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									                                                                       Toll Free Number: 800-447-9407

                                                                                         Live Webinar on

Complaint Handling in Compliance with FDA and ISO Regulations

Date: Tuesday, March 5, 2013                                            Time: 10:00 AM PST | 01:00 PM EST

Course "Complaint Handling in Compliance with FDA Duration:                     60 Minutes
and ISO Regulations" has been pre-approved by
                                                        Instructor:             Jeff Kasoff
RAPS as eligible for up to 1.00 credits towards a
participant's RAC recertification upon full completion. Location:               Online

                    Jeff Kasoff
                    Director of Regulatory Affairs,                         Register Now
                    Life-Tech, Inc

Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy and
colonoscopy devices, where he oversees the operation of the quality system. In this position, Jeff is
responsible for oversight of the document control system, including maintenance of regulatory
documentation.   ...more

Negative customer feedback about a medical device's performance or safety is a strong indicator of
whether a firm's manufacturing process is in control. This feedback is therefore subject to many
requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical
devices is among the most frequently cited observations on FDA-483s.

This session will include the requirements for defining, documenting, and implementing a complaint-
handling system, including the requirements for complaint review, investigation, and corrective
action, as well as the ISO-specific implications.

Areas covered in the session:

    l   FDA and ISO requirements for complaint handling
    l   Establishment of complaint handling program
    l   What constitutes a complaint
    l   ISO-specific implications of complaint handling
    l   The roles of investigation and corrective action in
        complaint handling
    l   Complaint trending and reporting
    l   Application of risk management to complaint
        handling program

Who Will Benefit:
                                           Suggest a Topic

    l   Regulatory Management              More Webinars
    l   Quality Management
    l   Customer Service
    l   Sales Personnel
    l   Quality System Auditors            Click here to
    l   Consultants                      register for this

It would be really nice if you can circulate this mail to all your deserving colleagues who can
immensely benefit from this program.

For more information, please contact the event coordinator. We look forward to seeing you at the webinar.

Best regards,

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