COURSE DESCRIPTION
OVERVIEW
There are many misconceptions on how to effectively manage and control medical device and in-vitro diagnostics product complaints using a coordinated, organized complaint handling system. It is critical for manufacturers and healthcare providers to understand how to effectively handle these complaints to ensure patient safety and compliance mandates from regulatory agencies. This course will examine and review FDA requirements and expectations in the handling of patient and provider concerns. It will also review and discuss organizational requirements along with proven techniques to ensure effective management of complaints.
LEARNING OBJECTIVES
By attending this 90-minute session, you will learn:
- The practical definition of a complaint – What is and what isn’t
- How to navigate the sea of records, forms, and procedures
- Triage – classifying complaints and understanding prioritization
- Organizational responsibility for the complaint handling system
- When to Report a complaint in accordance with 21 CFR Part 803
- Complaint v Service – The difference between the two and how they interact
- When to close a complaint file – corrective actions
David Lehman
I am interested in the Medical Devices – Effective Complaint Handling and Management course. Is a certificate of completion provided at the end?
bpompilii
Hello David, Yes, a completion certificate will be provided after the post course survey is completed.