Risk Based Approach to Software Quality Validation 2015

Topics

• The risk management in regulatory compliance
• The development of SOPs that include risk management
• How to prepare necessary SOPs
• The organization of Computer Validation processes that include risk management
• The responsibilities of the various stakeholders
• The content and format of SOPs

Who should Attend

Attendees from:

• Auditors
• Quality Assurance Staff
• IT Staff
• Subject Managers
• Regulatory Affairs