Dublin, Nov. 07, 2023 (GLOBE NEWSWIRE) -- The "CAPA (Corrective and Preventative Action) Training Course" conference has been added to ResearchAndMarkets.com's offering.
In today's tightly regulated pharmaceutical, biotechnology, medical device, and animal health industries, it is of utmost importance to employ efficient processes while ensuring strict compliance with an active Corrective and Preventive Action (CAPA) system.
CAPA procedures frequently draw the attention of regulatory inspectors, and it is imperative to provide evidence during any future inspections that CAPA actions have been not only identified but also effectively implemented.
This course is designed to equip you with the knowledge and skills needed to enhance your processes and establish a robust CAPA quality system. The program will include in-depth discussions of real-world CAPA examples and case studies, enriching your understanding of the course material.
This course has been thoughtfully crafted for professionals working within the pharmaceutical, biotechnology, medical device, or animal health sectors, particularly those involved in process improvement and responsible for meeting CAPA requirements.
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 andCAPA
- Managing the change and people issues
- Managing the stakeholders involved (stakeholder analysis)
Speakers:
Laura Brown
Pharmaceutical QA and Training Consultant
University of Cardiff
Dr 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.
For more information about this conference visit https://www.researchandmarkets.com/r/x0dybt
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