In today’s highly regulated pharma, biotech, device and animal health industries, it is essential to use the most efficient processes and ensure compliance with an active corrective and preventive action (CAPA) system.
CAPA procedures are a frequent focus of regulatory inspectors and evidence will be required at any future inspections that CAPA actions have been implemented.
This course will provide you with an understanding of how to improve your processes and implement and document an effective CAPA quality system. The programme will include discussion of CAPA examples and case studies to enhance course learning.
Benefits of attending:
- Understand CAPA methodology and documentation
- Learn tools and techniques to help make your existing processes more efficient and compliant
- Discover how you can address inspection findings using CAPA and process improvement
- Share best practice for CAPA
Certification:
- CPD: 6 hours for your records
- Certificate of completion
Agenda
Why is CAPA Important?
Best Practice for CAPA
CAPA Methodology and Documentation
- Identification
- Evaluation
- Investigation
- Analysis
- Action plan
- Implementation - execute the action plan, eg stakeholder analysis, the transition curve
- Follow-up - verify and assess the effectiveness of the CAPA
- Finding(s)
Diagnosing Process Improvement
- Using problem diagnosis (eg ‘root cause’ analysis) to understand why processes are unwieldy and help facilitate how to resolve inspection and audit findings
Developing Options for Process Improvement and CAPA
- Being more creative in problem solving of process simplification issues
- Flowcharts
- Evaluation of the attractiveness/likely difficulty of changes
- Continuous improvement - an invaluable approach for improving the implementation of regulatory change
Planning and Implementation in Process Improvements and CAPA
- Project managing process improvements and CAPA
- Managing the change and people issues
- Managing the stakeholders involved (stakeholder analysis)
Speakers
Dr Laura Brown,
Pharmaceutical QA and Training Consultant ,
University of CardiffDr Laura Brown MBA, BSc,PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years’ experience of quality assurance in the pharmaceutical industry and has worked for several companies, including GSKs Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality assurance including risked based approaches to quality systems, data Integrity and project management in the pharmaceutical industry. She regularly writes on pharmaceutical regulatory issues including “The Planning of International Drug Development”, in the Clinical Research Manual, Euromed and the “Impact of Brexit”, RQA Journal 2017.
Who Should Attend
This course has been specifically designed for those working in the pharma, biotech, device or animal health industries who are involved in process improvement and CAPA requirements.
