DUBLIN, Oct. 25, 2019 /PRNewswire/ -- The "Improving Processes and CAPA (Corrective and Preventative Action)" conference has been added to ResearchAndMarkets.com's offering.
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.
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
Agenda:
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
- Investigation
- 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
- Finding(s)
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)
Final Discussion
For more information about this conference visit https://www.researchandmarkets.com/r/qcawr8
Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.
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SOURCE Research and Markets
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