Docstoc

Complaint Handling in Compliance with FDA and ISO Regulations

Document Sample
Complaint Handling in Compliance with FDA and ISO Regulations Powered By Docstoc
					                                                                       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

Overview:
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
        Personnel
    l   Sales Personnel
    l   Quality System Auditors            Click here to
    l   Consultants                      register for this
                                              webinar

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,
Event-coordinator
GlobalCompliancePanel

About GlobalCompliancePanel
GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model
for online compliance training by creating a single window of learning opportunities for compliance
professionals & providing a forum for expert speakers/panelists to render their services through simplified
online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of
best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance
professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all
sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal
ensures a secure & cost effective online environment and also support your E-learning and development
on/through our website. Keep track of all webinars arranged for your industry through notifications & event
calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for
professionals.
GlobalCompliancePanel
www.globalcompliancepanel.com
43337 Livermore Common, Fremont,
CA 94539, USA


Phone: 800-447-9407 or
Fax your PO to: 302-288-6884
If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe

				
DOCUMENT INFO
Description: 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.