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.
A firm must implement an effective system to capture, document, correct and trend complaints, and equally important, to evaluate and identify customer feedback as to whether it qualifies as an MDR event. This webinar will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and corrective action. Also addressed will be 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. The application of risk management to a complaint handling system will be included.
Areas Covered in the Session:
- FDA requirements for complaint handling
- Establishment of complaint handling program
- What constitutes a complaint
- What constitutes an MDR event
- Evaluation of feedback as MDR: gray areas
- The roles of investigation and corrective action in complaint handling
- Complaint trending and reporting
- Application of risk management to complaint handling program
Director of Quality ,
Jeff Kasoff, RAC, is the Director of Quality at Medivators, a leading manufacturer of endoscopy consumables and instrumentation. In this position, Jeff is responsible for oversight of the quality system, including the CAPA program, and is the liaison with FDA. For the previous 13 years, Jeff served as Director of Regulatory Affairs at Life-Tech, Inc., in which capacity he was similary responsible for quality system oversight. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.
This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.
The employees who will benefit include:
- Executive/senior management
- Regulatory management
- QA management
- Any personnel who may have direct interaction with FDA officials
- Quality system auditors