FDA Warning Letter - Consent Decree Software Validation 2017

Key Topics

• Review of FDA software validation requirements
• Outline of FDA regulations as applied to software
• Proactive steps to prevent additional software-related compliance and enforcement problems
• Review of FDA software expectations
• Forward planning
• Response steps where inspection citations directly or indirectly include automated systems
• The paradox of ongoing validation work
• What to do about existing systems

Who should Attend

• External auditors
• Internal auditors
• Quality Assurance personnel and management
• Remediation personnel
• Consultants
• SQA - Software Quality personnel
• IT / IS managers
• Business managers responsible for system compliance
• Third-party certifier personnel
• Regulatory affairs personnel and management