International Requirements – Rules and Regulations
- European requirements
- The expectations of the FDA
- GMP and documentation issues
- Harmonisation in sight?
Deviation Handling
- How to document deviations
- Information and Data Management
- Critical/ major/ minor
- CAPA or not?
CAPA: Principles, System, Implementation and Process Improvements and the use of Risk Management Techniques
- Tools
- Quality Risk Management
- Human Error Overview
- Monitoring & Evaluation Overview
Process Analysis and Failure Investigation
Scenarios with a focus on using the tools from the presentation before:
- Human Error based
- Non-human Error based
Deviations in the Light of Inspections
- Focus in inspection
- Trends, Product Quality Review and Product Review
- Self-inspection as an important tool
Case Study: How to implement a CAPA System
- How to integrate existing QM Systems (OOS, Complaint Handling, Deviations)
- Examples and lessons learned
Case Study: How to deal with microbiological Deviations
- Contamination control and company culture
- What QA needs to understand
- Interface with QA and production
- OOS vs. deviation in the microbiological laboratory
- Possible CAPAs
Case Study: Implementation of a Software Tool for CAPA Management
- Understanding your workflows and processes
- Can you improve the current process using electronic workflows?
- Efficient validation of a CAPA application
CAPA Effectiveness & System Performance Check
- CAPA Effectiveness
- Why assessing effectiveness
- The meaning of effectiveness
- Determine effectiveness - System Performance
- Performance Monitoring
- Examples of Performance Indicators