Course Overview

With the increasing use of cloud systems in the pharmaceutical industry both as infrastructure and at the application level, understanding the expectations of the Health Authorities (MoH, FDA, MHRA, and EU) regarding GxP cloud systems and the validation of cloud systems is crucial.  
With this one day course, the impact of cloud systems on computer system validation will be discussed using the ICH Q9 quality risk management approach. Participants will receive answers to all relevant questions during this one-day session.
Join this course to learn how to apply Cloud System Validation in GXP Environment.

Benefits of attending:

• Gain a practical understanding of Cloud System Validation implementation.
• Improve your validation processes
• Understand the key factors for success
• Learn how to reach top maturity level

Who should attend?

This course is ideal for IT managers and Validation managers.
It will be relevant for everyone who participates in validation and compliance activities, both on managerial as well as on expert level, particularly those working in:

• Quality assurance
• IT
• CSV Validation Managers
• CSV Validation SME’s
• Project Managers

Program

Training Content:

• Definitions
• System Structure and Management
• Regulations (FDA, EU, MHRA)
• Relationship between Data Criticality and Integrity
• Ensuring Data Quality and Integrity during System Design
• Validation
• Q&A session

Other Details