Dr Martin M. Appel, Cilag AG, Switzerland
Marcus Heinbuch, B. Braun Melsungen AG, Germany
Mick Hopper, GxPpro, U.K.
Dr Bob McDowall, McDowall Consulting, U.K.
Rico Schulze, GMP Inspectorate, Germany
During this course, you will learn all relevant aspects to implement and/ or improve your Deviation Management and CAPA System to fulfil regulatory GMP requirements. 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 procedure 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 EU-GMP 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. Here it is also important to know how to deal with human error based and non-human error based non-conformances. Effective root cause analysis is the key to identifying appropriate CAPAs.
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 in 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 and decision makers who want to improve the existing process. 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?
CAPA: Principles, System, Implementation and Process Improvements and the use of Risk Management Techniques
- How to document deviations
- Information and Data Management
- Critical/ major/ minor
- CAPA or not?
Workshop: An interactive exercise on scenarios with a focus on using the tools from the presentation
- Quality Risk Management
- Human Error Overview
- Monitoring & Evaluation Overview
Deviations in the Light of Inspections
- Human Error based
- Non-human error based
Case Study: how to implement a CAPA System
- Focus in inspection
- Trends, Product Quality Review and Product Review
- The FDA approach
- Self-inspection as an important tool
Software tools for CAPA management as part of a QMS
- How to integrate existing QM-Systems (OOS, Complaint Handling, Deviations)
- Examples and lessons learned
CAPA Effectiveness & System Performance Check
- Understanding your paper workflows and processes
- Can you improve the current process using electronic workflows?
- An overview of some of the main software applications for CAPA
- Efficient validation of a CAPA application
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