Medical Device Complaint Handling Systems
Overview:
This webinar is intended to demonstrate how to adequately establish and maintain medical device complaint handling systems.
All medical device manufacturers are required to comply with the complaint handling requirements. Understanding the relevant and applicable requirement can significantly contribute to achieving compliance and remaining compliant, resulting in saving significant amount of time and efforts in business while ensuring the safety and effectiveness of the medical device products.
This webinar will discuss how to implement medical device complaint handling procedures, how to achieve compliance, and how to remain compliant. At the end of the webinar, you will get familiarized with the FDA-compliant system for handling all types of medical device complaints.
Why Should You Attend: FDA regulations require all medical device manufacturers to comply with the complaint requirements. This webinar will discuss how to adequately establish and maintain medical device complaint handling systems.
Areas Covered in the Session:
- Overview and review of the applicable statutes and regulations
- Definitions
- What to do when complaints are received?
- How to process complaints.
- What processes need to be in place?
- When to investigate complaints.
- When to open a CAPA(s).
- Contents of records of investigation.
- Enforcement actions: numerous case studies
- Lessons learned
Who Will Benefit:
- CEOs
- VPs
- Compliance officers
- Attorneys
- Complaint handling personnel
- Clinical affairs
- Regulatory affairs
- Quality assurance
- R&D
- CROs
- Consultants
- Contractors/subcontractors