The number one citation for the FDA 11 years running has been the issue of CAPA control and resolution. It was barely surpassed recently by Product and Process Control (P&PC) because of the inherent technology boom and the reduction of the human factor with the use of product and process software. CAPA is an engrained systematic approach to successfully improving processes and their integration in quality system (QSR).
The way that regulators get a handle on the scope and use of such a system is the inherent yet pragmatic application of CAPA. Internally this approach plagues many organizations due to the lack of balance for between the process of handling a CAPA and the intelligence factor of the team or person responsible for facilitating effective resolution.
- CAPA in the context of a QMS
- CAPA and its intent: fix-it, improve it, innovate
- CAPA: The human factor and the use of tools vs. process
- Analysis of Warning Letters in the context of poor process and communication
- Interactive Q&A Session
- Senior Management
- Middle Management
- Quality Departments
- Regulatory Affairs Departments
- R&D Departments
- Operations Departments
- Production Departments
- Manufacturing Departments
- Engineering Departments
- Marketing Departments
- Validation Departments
- Trial Audit Function
- IRB Members
FDB2392
