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An intensive one-day training course on how to establish and improve compliance with the GMP requirements for complaints handling, MDR and Vigilance reporting
Background
Compliance to the Medical Devices Directive (93/42/EEC), in vitro Diagnostic Medical Devices Directive (98/79/EC), FDA Quality System Regulation, 21 CFR Part 820, and ISO 13485:2003 requires medical device complaint handling to be managed in accordance with GMP requirements, and that certain serious types of complaints be notified to regulatory authorities.
Due to major deficiencies observed during inspections of such systems, FDA and Notified Bodies are increasingly raising non conformances against manufacturers who do not manage complaints handling in accordance with these requirements.
Learning Objectives
The course provides an opportunity to:
- To understand the regulatory requirements for managing complaints.
- Understand the EU Vigilance Reporting Requirements
- Understand the US Medical Device Reporting requirements contained in 21 CFR Part 803.
- On completion of the course delegates should be able to identify, plan and execute Vigilance and MDR activities in a structured and efficient manner, to satisfactorily meet the relevant regulatory responsibilities.
Course Details
The course presents the complaint handling requirements comprehensively, and uses interactive sessions as well as formal presentations. Each delegate is provided with a course manual containing comprehensive notes on topics presented, and copies of relevant regulations and guidance documents are provided for the use of delegates during the course.
Delegates receive a "Certificate of Attendance”.
Contact us for detailed training agenda and prices
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