FDA Warning Letter - Consent Decree Software Validation 2017 is a webinar that covers topics such as:
- 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
FDA Warning Letter - Consent Decree Software Validation 2017 brings together:
- 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
