Medical Device Complaints Handling Strategies

Why You Should Attend:

Why You Should Attend:

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 complaint-handling 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 Seminar:

- 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

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.

by: ComplianceOnline

POST COMMENT

Medical College Admission Test Improve Your Look At London Medical And Aesthetic Clinic Tips - Male Enhancement Drug That Really Works Medical Transcription Service Providers Provide Quality Services Sandbag - China Quality Medical Supplies - China Medical Elastic Bandage Medical Treatment Uprising Highly No problem, said Seretide GSK denied the two best-selling drugs have been stopped - GlaxoSmithKline - the pharmaceutical industries UN International Day Against Drugs CR systems allow you to acquire, archive, view and distribute medical images easily and inexpensively Work Uniforms And Medical Uniforms Fit Better When Measured Properly Medical Malpractice Lawyers Bow Draw - Forearm Crutch - Medical Aluminium Crutches Playstation 3 Accessories - China Medical Aluminium Crutches - China Medical Arm Crutch