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
Description
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Pricing
Live ( Single registration ) : $189.00
Group ( Max 10 Attendee): $249.00
On Demand (Recording available):$289
Get Training CD : $399
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 complainthandling 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
management system explained
Areas Covered in the Session:
FDA and ISO requirements for complaint handling
Establishment of complaint handling program
Who will benefit
What constitutes a complaint
This webinar will provide valuable
assistance to all regulated companies,
since complaint handling is a
regulatory requirement across the
Medical
Device,
Diagnostic,
Pharmaceutical, and Biologics fields.
The employees who will benefit
include:
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
Regulatory management
QA management
Customer Service personnel
Sales personnel
Consultants
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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