This CAPA training related to managing human error in regulated industries will explain the approach used in commercial, nuclear and aviation industries. It will help attendees understand effective CAPA implementation to successfully manage human error in regulated pharmaceutical, biotech and medical device companies.
Long Description: Ensuring effective CAPA and monitoring for assurance has been achieved successfully in two major high-risk industries, North America Commercial Nuclear and Commercial Aviation and Military Aviation. To obtain effective CAPA success it is essential to understand how to manage human errors and commercial nuclear and aviation have invested the time, money and resources to have expertise within their workforce.
This pharmaceutical CAPA training will discuss the effective Corrective and Preventive Actions learned by understanding the evolution of managing human error in nuclear and aviation industries and how to implement these actions in regulated pharmaceutical, biotech and medical device companies and all respective regulatory agencies.
This pharmaceutical, biotech and medical device CAPA training will cover the following topics:
- Deviation reduction (Goal: 0 deviations / batch)
- Achieve effective CAPA (Does “retraining or counseling work?”)
- Understand what is needed to achieve effective CAPA.
- Know why it is critical to manage human error.
- Begin to understand how to manage human error,
- Lessons learned from industries that have used this knowledge for success for 20+ years
- MOST IMPORTANTLY: Ensure PATIENT SAFETY; create cost savings for business / customer