This interactive module gives you the chance to assimilate the key concepts for making your computerized system compliant with GxP requirements, focusing on all the essential parts of validation.
In this module, our expert will give you answers to the following questions:
What is validation? What systems can be validated? What place does validation have in your computer programme? How do you validate? How can I keep my system validated?
Detailed content:
- Definitions and strategies
- Validation Master plan
- Validation plan
- Risk analysis
- Test phases: IQ, OQ, PQ
- Validation reports
- Change control
- Periodic review
Learner profile:
system owner, project manager, validation team, quality assurance, IT/IS.
Beginner level or refresher.
Interactive module made up of videos, animations and learning activities (quiz, drag and drop, etc.).
Duration: about 40 minutes, assessments included.
Training certificate: yes.
Once the final assessment has been passed (score >80%), you will receive a certificate in PDF format.
Term of validity for the module: 4 months after we have received payment
Volume discount available from 10
Access to a discussion forum where the learner and Trainer can communicate.
Valérie, computer project manager, consultant and Trainer at CVO-EUROPE, with over 24 years’ experience in quality control, quality assurance and ISD within the pharmaceutical industry (human and veterinary). Valérie is also ISTQB certified (Test Manager)
No pre-requirements needed.
Learner profile: system owner, project manager, validation team, quality assurance, IT/IS. Beginner level or refresher
Once payment has been made, you will firstly receive an email to confirm your order.
Then, within 48 hours (2 working days, after receiving your payment), we will send you an email confirming access to the module on our platform, CVO-EUROPE INSTITUTE. This access is personal and secured by a password.
The CVO-EUROPE INSTITUTE help service is available for any technical or functional questions.
For any questions regarding themes in the module, you can contact us via our discussion forum. One of our experts will answer you as soon as possible.
Once your training course is over, you will be asked to answer a satisfaction questionnaire and you can download, where appropriate, a certificate to prove you have followed the training course.