Quality Training

Introduction to Validation

Objectives

This is a foundation course - Introduction to Validation for medical technology industry.

Content includes

Understand the context of process validation within the Quality Management System
  • Be familiar with the definitions and terminology of validation
  • Know about the lifecycle of validation.
  • Appreciate the quality regulations pertaining to the Medical Device industry
  • Be familiar with the documents containing quality regulations
  • Consider what happens if validation goes wrong
  • Appreciate their own role in the product they validate, make or support
  • Understand the role of process control in maintaining a validated state
  • Consider the difference between validation and verification
  • Appreciate the documents and records required to support process validation.
  • Understand basic concepts of supporting regulations such as Part 11 compliance

Who should attend

Personnel who require an introduction to process validation

Upcoming dates:

No training dates available at the moment.

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Course

Introduction to Validation

Training Days

1 day

Training Locations

Cork, Galway, Limerick, Sligo

Course Cost

IMDA Skillnet Member: €150
Non-member rate: €200
* Cost quoted per person

"Course was very good and well presented and kept my interest all the way through."

Finbarr Smith
Validation Engineer
ProTek Medical, Sligo

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