Online Webinar 2015 - Complaint Handling in Compliance with FDA and ISO Regulations

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 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
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
Who Will Benefit:
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:
Regulatory management
QA management
Customer Service personnel
Sales personnel
Consultants
Quality system auditors
Speaker Profile
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.
Contact Information:
Compliance4All
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA
Phone:800-447-9407
Fax: 302-288-6884
support-AT-compliance4All.com
http://www.compliance4all.com