Best Practices for Preparation for_ Behavior during_ and Response to an FDA Inspection by JaySylvester1


									 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

                                            Areas Covered in the Session:

Live ( Single registration ) : $189.00    FDA and ISO requirements for complaint handling
Group ( Max 10 Attendee): $249.00
On Demand (Recording available):$289      Establishment of complaint handling program
Get Training CD : $399
                                          What constitutes a complaint
                                           ISO-specific implications of complaint handling
Who will benefit
                                           The roles of investigation and corrective action in
This webinar will provide valuable         complaint handling
assistance to all regulated companies,
since complaint handling is a              Complaint trending and reporting
regulatory requirement across the
Medical       Device,       Diagnostic,    Application of risk management to complaint
Pharmaceutical, and Biologics fields.      handling program
The employees who will benefit

Regulatory management                       About Speaker
QA management
Customer Service personnel
                                           Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a
Sales personnel
Consultants                                leading manufacturer of endoscopy products. In this position,
Quality system auditors                    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.

                          Compliance2go |
                          Phone : 877.782.4696 | Fax : 281-971-0286
                            Email :

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