Implementing Medical Device Complaint Systems
Description:
Description:
All medical device manufacturers are required to comply with the complaint handling requirements and medical device reporting (MDR) pursuant to the applicable statutes and regulations.
This webinar is intended to help you get familiar with how to implement the medical device complaint handling systems. This webinar is also intended to provide guidance on how to meet the regulatory requirements for handling any complaints concerning all medical device types.
Understanding the relevant and applicable requirements for the complaint handling system is neither an option nor insurance for compliance. The complaint handling system must be defined, documented, implemented and followed to achieve compliance and to remain 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 medical device complaint handling procedures, and requirements including how to achieve compliance and further to remain compliant. At the end of the webinar, you will get familiarized with the system for handling all types of medical device complaints and further, you will leave refreshed and motivated to take action.
Objectives of the Presentation:
Applicable statutes and regulations
Definitions
What to do when complaints are received?
How to process complaints.
What processes/procedures need to be in place?
What/how/when to investigate complaints.
Contents of records of investigation.
How the complaint handling system should be tied to the MDR.
How the complaint handling system should be tied to the CAPA system.
Enforcement actions: case studies
Lessons learned
Who can Benefit:
CEOs
VPs
Compliance Officers
Attorneys
Complaint Handling Personnel
Clinical Affairs (Associates, Specialists, Managers, Directors or VPs)
Regulatory affairs (Associates, Specialists, Managers, Directors or VPs)
Quality assurance (Associates, Specialists, Managers, Directors or VPs)
R&D (Engineers, Scientists, managers, Directors or VPs)
CROs
Consultants
Contractors/Subcontractors
Pricing
Live Session for one participant
Price: $243.00
Corporate Live Session 4 to 10 participants in single location.
Price:$986.00
Recorded Session Access recorded sessions only for one participant unlimited viewing for 6 months.
Price: $288.00
by: Dr. David Lim
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