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CAPA (Corrective and Preventative Action) Training Course
This course 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.
Details
Course overview
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
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.
Programme
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)
Presenter
Laura Brown (More...)
Dr Laura Brown is an independent pharmaceutical QA consultant and the Senior Lecturer for the MSc in Clinical Research at the School of Pharmacy, Cardiff University. Laura is a recognised expert in QA including auditing SOPs for regulatory compliance. She has more than 25 years’ international experience in the pharmaceutical industry in a number of senior roles and has worked for companies including GSK, Hoechst Marion Roussel, Farmitalia and Phoenix International. She has worked in several quality assurance roles which have included writing, reviewing and auditing SOPs and CAPA implementation and has helped companies prepare SOPs and review CAPA systems to meet regulatory requirements.
Book now
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29 Jun 2021 Live webinar |
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29 Jun 2021 Live webinar |
GBP 599.00 EUR 859.00 USD 970.00 + VAT @ 20.00% |
Enrol now
to attend Live webinar |
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3 Dec 2021 Live webinar |
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3 Dec 2021 Live webinar |
GBP 599 499 EUR 859 719 USD 970 814 Until 22 Oct* |
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to attend Live webinar |
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7 Dec 2021 Face-to-face, (venue not yet confirmed) |
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7 Dec 2021 Face-to-face (venue not yet confirmed) |
GBP 699 599 EUR 979 839 USD 1,090 934 Until 26 Oct* |
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to attend Face-to-face (venue not yet confirmed) |
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* Note the early booking discount cannot be combined with any other offers or promotional code