Course Details
The aims and learning outcomes of this course are:
- To understand the requirements of process validation.
- To have a basic knowledge of the requirements of Verification and Validation of medical devices.
Following completion of this course, participants should:
- Understand the requirements of Verification and Validation.
- Be able to actively participate in the processes of Verification and Validation.
- All participants should have a working knowledge of the Essential Principles and how verification and processes demonstrate compliance.
This is a one day course in which participants will fully engage with the lecturer through group and individual exercises. There are plenty of opportunities to ask questions and the course can be fully tailored to the company’s products and internal structure.
This course works through the requirements of Verification and Validation across the quality and regulatory landscape and is broken down into 3 modules.
- Introduction to Verification and Validation.
- Process Verification and Validation.
- Essential Principles and application of Verification and Validation.