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Improving Processes and CAPA (Corrective and Preventative Action)

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.

4 Dec 2020

& 29 Jun 2021 , 3 Dec 2021

GBP 699
EUR 979
USD 1,090

Book now

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

Book both

This meeting runs back-to-back with How to Write SOPs and there is a further £100/€140 discount off this programme when booked together.

To register on both events click HERE

To find out more call Customer Services on +44 (0)20 7749 4730 or e-mail info@management-forum.co.uk

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.

Course 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

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.

Book now

4 Dec 2020
4 Dec 2020 Venue not yet confirmed GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
Enrol now
29 Jun 2021
29 Jun 2021 Venue not yet confirmed
+ VAT @ 20.00%
Enrol now
3 Dec 2021
3 Dec 2021 Venue not yet confirmed
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • Abbott Healthcare Products Ltd
  • ALEXION Europe SAS
  • Associates of Cape Cod International Inc.
  • Bayer Healthcare
  • Bayer Medical Care BV
  • Bayer plc
  • Boehringer Ingelheim
  • Chiesi Ltd
  • Cipla Ltd
  • Colorcon Limited
  • DHL Hospital Logistics Centre
  • Eisai Europe Limited
  • Ewopharma AG
  • Ewopharma International, s.r.o.
  • IBSA SA
  • LEO Pharma A/S
  • Mercury Pharma Management Services Ltd
  • MSD Ltd
  • Mundipharma Research GmbH & Co Kg
  • Mundipharma Research Ltd
  • Novartis Vaccines & Diagnostics SRL
  • Oxford Pharmascience
  • Philips Respironics
  • Sanofi-Aventis R&D
  • Sekisui Diagnostics (UK) Ltd
  • SGS Belgium NV Life Science Services
  • SmartlineGroup
  • SSI Diagnostica
  • Torbay Pharmaceuticals
  • Vifor Pharma UK Limited

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

Very clear, friendly and knowledgable.

Claire McGuinness, Medical Research Chemist, Mexichem, Dec 18

Very good.

Heidrun Mylius, Senior Medical Writer & Process Improvement Manager, Medac GmbH, Dec 18

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

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

Informative and engaging. Thoroughly enjoyed it

Malgorzata Wilinska, Research Associate, University of Cambridge, Dec 17

Very good, interesting and enjoyable

Chris Martin, Quality Engineer, Remote Diagnostic Technologies Ltd, Dec 17

Pleasant, friendly, engaging and very knowledgable

Diana Kalmoni-Hassay, Reports, Submissions and Compliance Associate, GW Pharmaceuticals plc, Dec 17

It was well packaged, concise and to the point.

Bolutife Adeyemi, Senior PV 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

Enjoyable course, with a very good presenter.

Sophie Thompson, Quality Engineer, Wesley Coe (Cambridge) Limited, Dec 16

I found it useful and was happy to attend this course again

Esther Janssen, Compliance Manager, Ferring Pharmaceuticals A/S, Dec 16