Validation Principles and Practices for Medtech

Date: 4th March 2021 -
20th May 2021
Time: 19:00 - 20:00
Duration: 12 wks (+ 2 wk for assignment)
Venue: Online Virtual *** FULLY BOOKED ***
Address: First day intro plus live weekly tutorials.
- Weekly live tutorials Thurs 19:00-20:00
- Submission 4,000 word dissertation 3 June
- 12 weeks plus 2 weeks for the assignment
Event details:

Validation Principles and Practices for Medtech

Validation Principles and Practices programme for the medical technology industry

This programme has been designed to meet the growing requirements of Irish companies in filling validation roles and is delivered through blended learning. The impetus for the development of this specialist programme emerged from industry needs and the content has been developed in conjunction with a taskforce comprised of validation experts from medical technology sector.

The course will enable personnel in the medical technology industry to understand all current device and diagnostic validation regulations and to develop the skills necessary to address and prepare for the scope of validation requirements in industry.

The Validation professional is critical to making safe and effective medical products available to patients worldwide. These professionals ensure compliance to international medical device regulations for designing and manufacturing medical device products.

The aim of the course is to introduce participants to the fundamentals of Validation, providing them with a basic knowledge of the regulations, standards and the skills necessary for validation work in the Medical Device sector. This course will cover international validation requirements pertaining to validation and all associated systems.

The course content will follow the following themes:
· Quality Management Systems and where validation aligns to the Quality Management Systems.
· Validation and certification bodies’ requirements within Validation.
· Writing best practice protocols and documentation.
· Risk, risk management and compliance within Validation.
· The key elements of validation throughout the life cycle of a medical device product.
· Support systems required to maintain a validated state.

Validation professionals are one of the most in-demand professions in the Medical Device Industry. This module allows for professionals in the medical device industry and those with an interest in validation to develop the fundamental skills to contribute as effective members of a validation team in the medical devices sector.

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