Qualification and Validation for Pharma and Medical Devices
Qualification and Validation for Pharma and Medical Devices
Basic Level | Course | English | Pharma and Medical Device | 40 minutes
Corresponds to ½ day of teacher-directed learning
Description
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 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
Course module
1. Qualification and Validation for Pharma and Medical Devices
This course covers basic principles of qualification, validation, and FDA/EU compliance to help you ensure top-quality and safe pharmaceutical and medical device products.
Trainer: Virtual character
Duration: 40 minutes (Total duration of the course: 40 minutes)
Course material
There is no additional course material for this course.
Notes
If you want to save your notes for this course, you first need to purchase it and be signed in.
Training organisation
Key2Compliance AB
Key2Compliance AB is an independent international organization providing its training and services to a variety of functions in the Life Science industry, from development to market in terms of Quality Systems and Regulatory compliance.
By helping organizations to comply with regulatory expectations, to enhance workforce knowledge and motivation and to promote a correct attitude towards quality, we believe we contribute to the supply of safe health care products - and in a wider perspective we save lives.
Trainer
Virtual character
This training is created by Key2Compliance AB and uses a digital avatar to convey the presented concepts, which enhances clarity and understanding of the content.
The course results in a diploma that shows that you have the skills required.
All prices shown exclude VAT.
Save time
Online education is faster than traditional education. We make the same courses and content accessible in just under a third of the time normally required.
The efficiency gain is due to the fact that there are no lunch breaks, no commute, no group discussions, and no breaks. However, the total time spent teaching always remains intact.
1 h - Equivalent to a half-day course
2 h - Equivalent to an all-day course
4 h - Equivalent to a 2-day course
6 h - Equivalent to a 3-day course
Please note that the duration specified does not include time for breaks or revision. Don't forget to set aside time for any workshops and time to take the tests of the course, which is required to earn a diploma.
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