Complaint Handling & Vigilance Reporting Training Course
| Topic of the Course | Complaints Management and Vigilance Reporting Process |
| Course Duration | 2.5 – 3 hours |
| Type of Course | e-Learning, Online & Self-Paced |
| Cost | € 119,00 (VAT Excluded) |
Course Contents
0 – General Introduction to the Course
Course Description and Duration
Structure of the Course
Objective of the Course
Assessment of Learning AchievementsPrerequisite and
Course Certificate
1- Introduction to Complaint ManagementDefinition of Complaint Handling
Complaint Management Process
Complaint Criteria & Definition of Complaint
2 – Vigilance Reporting Process
Introduction to Article 87 of EU MDR and Timeline for Vigilance Reporting.
Reporting Requirements for Use Error and Abnormal Use
Preparation and Submission of Vigilance Reports
IMDRF Classification of Adverse Events
Vigilance Reporting Requirements in United States and in Australia
3 – Root-Cause Analysis and Complaint Closure
Strategy for Complaints Investigation
Techniques for Root-cause Analysis
Link Between Complaint Management and CAPA Process
Compliant Closure and Communication to Customers
4 – Trend Reports, Analysis of Serious Incidents and Field Safety Corrective Actions.
Trend Reporting Requirements according to EU MDR and IVDR
Examples of Statistical Approach for Trend Reporting
Integrated Process for Trend Reporting
Field Safety Corrective Actions and Field Safety Notice.
5- Post-Market Risk Management
Risk Management, Post-Market Surveillance and Post-Market Clinical Follow-up.
Management of Production and Post-Production area.
Actions following the review of PostProduction Data.
Correlation between ISO 14971, ISO 13485 and ISO/TR 20416.
Practical Information
General Description
This online & Self-Paced Training Course is focused on compliant management and vigilance reporting process, according to the requirements of EU MDR 2017/745 and IVDR 2017/746. For a more detailed description of the course, refer to the section related to the course contents.
Who Should Attend the course?
This course should be followed by anyone interested in post-market surveillance for medical device sector, and, in any case, anybody working on complaint management and vigilance reporting.
Course Access
During payment process, your account will be created. You will receive an email with a link to access your account area. Training courses can be attended only after user account creation.
Structure of the Course
This course is divided into four different sections. At the end of each session, there are some tests and exercises aimed at consolidating the information related to each part of the course. At the very end of the course, a final test can be performed.
Course Certificate
At the end of the course, upon successful completion of all the intermediary and test. Each test shall be passed with a minimum score of 70%.
Prerequisites
No specific prerequisites are requested to attend this course. However, general knowledge of ISO 13485 and EU MDR / IVDR would be beneficial, although not mandatory or requested.
