Live webinar By Compliance2go by compliance2go


									 Live Webinar on : Best Practices for Complaint Handling in Compliance with FDA
 and ISO Regulations
 Wednesday, July 25, 2012 duration : 01:00 to 02:00 PM EDT


                                          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
Get 15 % Discount as a early bird         about medical devices is among the most
registrations. Use Promo Key :            frequently cited observations on FDA-483s. This
 CGO15                                    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 "non-complaint"
                                          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
Pricing                                   management system explained

Live ( Single registration ) : $189.00    Areas Covered in the Session:
Group ( Max 10 Attendee): $249.00
On Demand (Recording available):$289      FDA and ISO requirements for complaint handling
Get Training CD : $399
                                          Establishment of complaint handling program
Who will benefit                           What constitutes a complaint

This webinar will provide valuable         ISO-specific implications of complaint handling
assistance to all regulated companies,
since complaint handling is a              The roles of investigation and corrective action in
regulatory requirement across the          complaint handling
Medical       Device,       Diagnostic,
Pharmaceutical, and Biologics fields.      Complaint trending and reporting
The employees who will benefit
include:                                   Application of risk management to complaint
                                           handling program
Regulatory management
QA management
Customer Service personnel
Sales personnel
Quality system auditors

                                           About Speaker

                                           Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a
                                           leading manufacturer of endoscopy products. In this position,
                                           Jeff is responsible for supplier management, during which he
                                           oversees supplier management, CAPA, and document control.
                                           Prior to this, Jeff spent 13 years at Life-Tech as the Director of
                                           Regulatory Affairs, where he was responsible for regulatory
                                           compliance of all aspects of the quality system. Jeff received
                                           his regulatory affairs certification in 1996.

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