Once the FDA inspectors or Fedral marshalls have arrived, it's time to set up an effective software validation and software quality program - even if those were not the original citations that brought you to FDA's attention. Attend this Webinar if you have received, expect or fear an FDA-483, Warning Letter or Consent Decree. Learn steps that can be done proactively and forward plan to prevent additional software related compliance issues and how to prepare response where citations directly or indirectly include automated system.

Areas Covered in the seminar:

- Outline of FDA regulations as applied to software.
- Review of FDA software validation requirements.
- Review of FDA software expectations.
- Proactive steps to prevent additional software-related compliance and enforcement problems.
- Response steps where inspection citations directly or indirectly include automated systems.
- Forward planning.