Who should attend?

• Notified Body Auditors, who wish to maintain qualifications
• Notified Body Auditors, who wish to have certified evidence of qualifications
• Auditors performing second party audits of sterile medical devices
• Regulatory affairs professionals
• Quality assurance professionals

Who Should Attend?

§ Quality Assurance Personnel

§ Regulatory Professionals

§ Production Managers

§ Engineering and Management Personnel who have responsibility for functions regulated by the FDA, or who may be called upon to interface with inspectors during an inspection.

Benefit of attending

§ Understand the essentials of an effective CAPA system

§ Meet compliance requirements, particularly for EU and US medical device regulation.

§ Implement closed loop continuous improvement

§ Understand the key differences between ‘corrective’ and ‘preventive’ action.

Programme

§ Introductions and definitions

§ MDD & FDA requirements for CAPA

§ Elements of a CAPA system including documentation and records

§ Cause analysis: investigation of root causes

§ Problem solving

§ Verification and validation of solutions

§ Problem prevention

§ Ensuring successful implementation

§ Evaluating the system

§ Close-out

§ Trending of problems for prevention and management review