This Medical device training will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and corrective action.
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 seminar:
- 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.
Who will benefit:
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
- Consultants
- Quality system auditors
Instructor Profile:
Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance with domestic and international regulations, preparation of submissions, and is primary liaison with regulatory agencies and notified bodies. 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.
