Marcus Heinbuch, B.Braun Melsungen, Germany
Dr Ulrich Herber, Charles River, Ireland
Mick Hopper, GxPpro, U.K.
Lea Joos, GMP/GDP Inspectorate, Germany
Manuel Suhrada, Switzerland
During this course, you will get to know the principles and discuss all relevant aspects to implement, improve and/ or work with a Deviation Management and CAPA System. Furthermore, you will get to know possibilities and tools to monitor and evaluate your CAPAs.
Things will go wrong from time to time. In the world of pharmaceuticals, we need to ensure that we have robust processes and procedures in place to deal with such situations. When an unplanned event arises it must be handled accordingly.
FDA’s Quality System Guide, recent Warning Letters and EUGMP Chapter 1 clearly emphasise the increasing relevance of a proper deviation management and CAPAs. ICH Q9 on Quality Risk Management and ICH Q10 on Pharmaceutical Quality Systems empower us to handle issues that arise in our daily work on the basis of risk analysis.
In any case a sound failure investigation is the key to identify appropriate CAPAs. Here it is also important to know how to deal with human error based and non-human error based non-conformances.
Independent from that, it needs to be pointed out that CAPA is an excellent Quality Management tool to continuously improve processes and avoid future failures. All personnel involved in the management of deviations and CAPAs should aim to identify opportunities for further improvement.
This course is designed for all personnel involved in Deviation Management and CAPA activities at their company. It is addressed to persons from Quality Assurance and Control, Manufacturing and R&D.
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
- 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
- CAPA Effectiveness
- Why assessing effectiveness
- The meaning of effectiveness
- Determine effectiveness
- System Performance
- Performance Monitoring
- Examples of Performance Indicators
Workshop on CAPA Effectiveness & System Performance Check
An interactive session with a focus on enhancing the knowledge gained in the presentation.