DUBLIN, Oct. 27, 2023 /PRNewswire/ — The “CAPA (Corrective and Preventative Action) Training Course” conference has been added to ResearchAndMarkets.com’s offering.
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.
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
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:
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/kx2ay4
About ResearchAndMarkets.com
ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
Media Contact:
Research and Markets
Laura Wood, Senior Manager
[email protected]
For E.S.T Office Hours Call +1-917-300-0470
For U.S./CAN Toll Free Call +1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Logo: https://mma.prnewswire.com/media/539438/Research_and_Markets_Logo.jpg
SOURCE Research and Markets