International Requirements – Rules and Regulations
- European requirements
- The expectations of the FDA
- GMP and documentation issues
- Harmonisation in sight?
- 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
- Quality Risk Management
- Human Error Overview
- Monitoring & Evaluation Overview
Workshop: An interactive exercise on scenarios with a focus on using the tools from the presentation
- 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
As part of the periodic quality review programme, Quality Management should routinely analyse reports of deviations and CAPAs to determine KPIs, trends, recurrence of non-conformances and effectiveness of CAPAs.
A summary overview should be reported to the Senior Management team. ICH Q10 identifies this as best practice - but are we doing this as well as we could or should?
We will discuss Quality Metrics as well as which are the important ones that will show you have a good Pharmaceutical Quality System.
Workshop on CAPA Effectiveness & System Performance Check
An interactive session with a focus on enhancing the knowledge gained in the presentation.