Computer System Validation (CSV) and Computer Software Assurance (CSA)

Discover the power of CSV and CSA in life sciences

Are you working in the pharmaceutical or Life Science sector and involved in Computer System Validation (CSV) and Computer Software Assurance (CSA)? Our training provides you with the essential knowledge and practical skills to excel in a GxP environment. Sign up for the morning session (basic), the afternoon session (advanced), or the full day and elevate your expertise. Don't miss this opportunity to enhance your professional future!

Target Audience

This training is designed for professionals in the pharmaceutical or Life Science sector who work in a GxP environment and deal with Computer System Validation (CSV) and Computer Software Assurance (CSA).

Training Overview:

1. Basic Training (Morning)

Time: 09:00 - 12:30

Cost: €395

In the basic training, we start with the definition of validation and its importance in the pharmaceutical industry. We cover the following topics:

• Goals of validation and the current relevance of computerized system validation.
• Regulatory requirements.
• Different phases of validation throughout the lifecycle of a computerized system.
• Essentials for the validation plan, validation tests, and the report.

The morning session concludes with an interactive workshop where we:

• Revisit the components of validation.
• Attempt to design a test script.
• Address other relevant topics together.

 2. Advanced Training (Afternoon) 

Time: 13:30 - 17:00

Cost: €395

The advanced training delves deeper into the subject with the following topics:

• Data Integrity and an alternative approach to the system lifecycle.
• Regulatory items to comply with.
• Identity access management.

We also explore the future of validation, focusing on the differences between CSV and CSA.

The afternoon session also concludes with a workshop where we:

• Tackle several complex issues.
• Draft fictitious requirements and test scripts.
• Dive deeper into the concepts of CSA.

3. Full Day Training

Time: 09:00 - 17:00

Cost: €595

For those seeking a comprehensive and thorough training, we offer the option to enroll for the full day. This includes both the basic training in the morning and the advanced training in the afternoon.

Registration

Choose from the following options:

• Basic Training (Morning) - €395
• Advanced Training (Afternoon) - €395
• Full Day Training - €595

Register via the form below and let us know which option you are signing up for.

Questions?

If you have any questions about the registration or the content of the training, please feel free to contact us.