Qualification and Validation for Pharma and Medical Devices

This introductory course provides a basic understanding of the key principles and practices involved in qualification and validation. You’ll learn about equipment qualification, process validation, and compliance with FDA and EU guidelines. Enhance your skills to ensure your pharmaceutical and medical device products meet the highest quality and safety standards.

This training has been developed by the experts at GBA Key2Compliance. The films are animated and designed to enhance understanding and perception of the presented concepts and are presented by AI generated speakers.

The training is divided into 2 modules: a general presentation and short exam. After the successful completion of both modules, you will receive your Certificate of Completion.

Content

• What validation is and why it is important
• Overview of applicable regulations and guidelines for pharmaceuticals and medical devices
• Lifecycle of the validation process and associated key concepts and terminology
• Overview of special cases and their associated requirements

Duration: 40 minutes

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