Online Event Location map
Complaint Handling in Compliance with FDA and ISO Regulations
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
- Quality system auditors
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.
Don't wait to register for the Complaint Handling in Compliance with FDA and ISO Regulations. You'll meet influential people and maximize your opportunities for success. Start now by accessing the information below.
Customer Service personnel
Quality system auditors
Exhibitor Information +