Improving Processes and 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 Course Director 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
Book now
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4 Dec 2020 Live webinar |
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4 Dec 2020 Live webinar |
GBP 499.00 EUR 719.00 USD 814.00 Until 23 Oct* |
Enrol now
to attend Live webinar |
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29 Jun 2021 Live webinar |
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29 Jun 2021 Live webinar |
GBP 499.00 EUR 719.00 USD 814.00 Until 18 May 21* |
Enrol now
to attend Live webinar |
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1 Jul 2021 Face-to-face, (venue not yet confirmed) |
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1 Jul 2021 Face-to-face (venue not yet confirmed) |
GBP 599.00 EUR 839.00 USD 934.00 Until 20 May 21* |
Enrol now
to attend Face-to-face (venue not yet confirmed) |
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3 Dec 2021 Live webinar |
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3 Dec 2021 Live webinar |
GBP 499.00 EUR 719.00 USD 814.00 Until 22 Oct 21* |
Enrol now
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 599.00 EUR 839.00 USD 934.00 Until 26 Oct 21* |
Enrol now
to attend Face-to-face (venue not yet confirmed) |
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Learn more about our face-to-face and webinar training formats.
* Note the early booking discount cannot be combined with any other offers or promotional code
Customised in-house training
We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.
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Previous customers include...
- Arnold & Porter (UK) LLP
- Arriello
- Bayer Pharma AG
- Bespak Europe Ltd
- BOC Micro applications centre
- Boehringer Ingelheim BV
- Bray Group Ltd
- Celgene
- Celgene Europe Ltd
- Celgene International Sarl
- Chesapeake Pharmaceutical & Healthcare Packaging
- Cipla Ltd
- Eisai Europe Limited
- EORTC
- Genzyme Europe BV
- GSK
- GSK Consumer Healthcare S.A
- IBSA SA
- Keyrus Biopharma
- Laboratorios CINFA
- Mercury Pharma Management Services Ltd
- Pharmaspec Specials
- PrimeVigilance Zagreb d.o.o.
- Procter & Gamble
- Roche (Israel) Pharmaceuticals
- Roche Products Ltd
- SGS Belgium NV Life Science Services
- Takeda
- UCB Pharma SA
- VESO Vikan
“Excellent.”
Hannah Allende, Assistant Clinical Trials Manager, University Hospitals Plymouth NHS Trust, Dec 19
“A very talented speaker.”
Mario Mohos, Quality Supervisor, Mylan Hungary Kft, Dec 19
“The course was well planned and executed. The balance of the course overhead slides and practical exercises were well balanced. This course is very good for anyone wanting to understand CAPA planning and Root Cause analysis. I would highly recommend this course to any Quality/ Production persons in the Pharma industry. Well done Management Forum! ”
Sameer Hashmi, Quality Associate, Animalcare, Dec 18
“Very good. ”
Heidrun Mylius, Senior Medical Writer & Process Improvement Manager, Medac GmbH, Dec 18
“Very clear, friendly and knowledgable. ”
Claire McGuinness, Medical Research Chemist, Mexichem, Dec 18
“Excellent speaker, good presentation and content. ”
Faiz Aziz, Technologist , Colorcon, Jun 18
“Excellent content, good speaker. Interacted with everyone. ”
Faiz Aziz, Technologist , Colorcon, Jun 18
“It was well packaged, concise and to the point.”
Bolutife Adeyemi, Senior PV Associate, GW Pharmaceuticals plc, Dec 17
“Very good, interesting and enjoyable ”
Chris Martin, Quality Engineer, Remote Diagnostic Technologies Ltd, Dec 17
“Informative and engaging. Thoroughly enjoyed it ”
Malgorzata Wilinska, Research Associate, University of Cambridge, Dec 17
“Pleasant, friendly, engaging and very knowledgable ”
Diana Kalmoni-Hassay, Reports, Submissions and Compliance Associate, GW Pharmaceuticals plc, Dec 17
“Very good overview”
Alexandra Beer, Senior Quality Manager, Animax Ltd, Jun 17
“Excellent”
Olga Vorobyeva, QMS Specialist , Arriello, Jun 17
“I found it useful and was happy to attend this course again”
Esther Janssen, Compliance Manager, Ferring Pharmaceuticals A/S, Dec 16
“Useful course which I have definitely benefited from attending”
Ken Barratt, Production & Quality Manager, The National Artificial Eye Service, Dec 16