This training will show how you can handle customer complaints in compliance with FDA and ISO Regulations. We will discuss the best ways to document customer feedback, what constitutes a complaint, what do with "non-complaint" feedback, and how to include complaint trending into your firm’s CAPA program.
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 complaint handling webinar 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 Quality at Byrne Medical, a leading manufacturer of consumables and instrumentation in the endoscopy field. In this position, Jeff is responsible for oversight of the quality system, including phase approval of design history files. For the past 13 years, Jeff served as Director of Regulatory Affairs at Life-Tech, Inc., where he was responsible for corporate compliance. 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.
