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RAPS Approved Webinar


Complaint Handling in Compliance with FDA and ISO Regulations

Date & Time: Course "Complaint Handling in Compliance with FDA and ISO Regulations" has been pre-approved by RAPS as eligible for up


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to 1.00 credits towards a participant's RAC recertification upon full completion. Instructor Profile: Wednesday, September 19, 2012

10:00 AM PDT | 01:00 PM EDT

Duration: 60 Minutes

Instructor: Jeff Kasoff

Location: Online

Price : $245.00

(for one participant)

Overview: 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. This session will discuss the best way to document customer feedback, what constitutes a complaint, and what do with "noncomplaint" feedback. Also contained will be a suggested method on including complaint trending into your firm's CAPA program. Additionally, the application of risk management to a complaint handling system will be reviewed, and a specific risk management system explained.

Why Should You Attend: Negative customer feedback about a medical device's performance or

Jeff Kasoff Director of Regulatory Affairs, 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. Prior to this, Jeff spent 13 years at Life-Tech, Inc. as the Director of Regulatory Affairs, where he was responsible for compliance of the corporate quality system. Jeff received his regulatory affairs certification in 1996. ...more

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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.

Areas Covered in the Session: l l l l l

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

Click here to register for this webinar Who Will Benefit: l

Regulatory management


QA management Customer Service personnel Sales personnel

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Consultants Quality system auditors

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 1000 N West Street Suite, 1200 Wilmington DE 19801 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

Complaint Handling in Compliance with FDA and ISO Regulations  
Complaint Handling in Compliance with FDA and ISO Regulations  

Overview: This session will include the requirements for defining, documenting, and implementing a complaint-handling system, including the...