This meeting will cover CAPA methodology and documentation, diagnosing process improvement, developing options for process improvement and CAPA and planning and implementation in practice of improvements and CAPA
With this one-day course you will learn how to use the most efficient processes and ensure compliance with Corrective and Preventative Action (CAPA) within the pharmaceutical, medical device and animal health industries.
Regulatory inspectors are increasing reviewing responses to findings dealt with by the CAPA approach and process improvement. It is highly likely that organisations who have already been inspected will be assessed at their next inspection in terms of whether the corrective and preventative actions have been implemented. If previous major findings have not been addressed then a critical finding may be given. This course will be ideal for you to learn how to improve industry procedures and processes and how to implement and document an effective CAPA quality system.
Why you should attend
It is highly likely that organisations who have already been inspected will be assessed at their next inspection in terms of whether the corrective and preventative actions have been implemented – has the organisation done what they said they would? If previous major findings have not been addressed then a critical finding may be given. This couse will be ideal for you to learn how to improve industry procedures and processes and how to implement and document an effective CAPA quality system.
Topics to be covered include:
- 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
Why is CAPA important?
CAPA Methodology and Documentation
- Identification - clearly define the problem
- Evaluation - appraise the magnitude and impact, e.g. scenarios, test out assumptions and help identify potential risks
- Analysis - perform a thorough assessment - review data, prioritise, develop options for solutions
- Action Plan - create a list of required tasks
- Implementation - execute the action plan, e.g. stakeholder analysis, the transition curve
- Follow Up - verify and assess the effectiveness of the CAPA
Diagnosing Process Improvement
- Using problem diagnosis (for example, “root cause” analysis) for understanding why processes are cumbersome and to help facilitate resolving audit and inspection findings
Developing Options for Process Improvement and CAPA
- Being more creative in problem solving of process simplification issues
- Evaluation of the attractiveness/likely difficulty of changes (“AID” analysis)
- Continuous improvement teams - as an invaluable approach for improving the implementation of regulatory change
Planning and Implementation in Practice of Improvements and CAPA
- Project managing process improvements and CAPA
- Managing the change and people issues
- Managing the stakeholders involved (stakeholder analysis)
Dr Dr. Laura Brown,
Pharmaceutical Management and Training Consultant ,
University of Cardiff
Dr Laura Brown MBA, BSc (Biochemistry), BSc (Psychology), PhD, Diploma in Clinical Science, FICR, is a Pharmaceutical Management and Training Consultant, Course Director for the MSc in Clinical Research at the University of Cardiff, and MSc Regulatory Affairs, TOPRA.
She has more than 19 years experience in the pharmaceutical industry and has worked for several companies, including GlaxoWellcome, Hoechst Marion Roussel, Farmitalia and Phoenix International. She has worked in Drug Development, Clinical Research, Quality Assurance and Marketing. Laura has a particular expertise in Clinical Research and GCP issues. She was Chairman of the ACRPI GCP Forum for six years. She regularly writes on clinical research issues and ICH GCP, is author of SCRIP’s GCP guide and is a member of the editorial board of the Board of the Good Clinical Practice Journal. In addition to her scientific qualifications, she has a degree in psychology and an MBA.
Laura is co-author of several books on management including Developing the Individual, The Ultimate Book of Business Skills and Pharmaceutical Project Management.
The course has been specifically designed for the Pharma, Biotechnology, Devices and Veterinary industries and particularly if you are involved in process improvement, corrective and preventative action, problem solving and managing inspections and documenting how to deal with these.
The Rembrandt Hotel
11 Thurloe Place
Opposite V&A Museum.
Nearest underground station: South Kensington.