Improving Processes and CAPA (Corrective and Preventative Action)

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

28 Jun 2019

& 3 Dec 2019

GBP 699
EUR 979
USD 1,090

Book now

Course overview

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.

We are also running

Book both

This meeting runs back-to-back with How to Write SOPs on 3 December 2018 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

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

Who should attend

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.

Course programme

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

Presenter

Laura Brown (28 Jun 2019)

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

28 Jun 2019
28 Jun 2019 Rembrandt Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
Enrol now
3 Dec 2019
3 Dec 2019 Rembrandt Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • Abbott Healthcare Products Ltd
  • Alfrapharma Srl
  • Animalcare
  • Arnold & Porter (UK) LLP
  • Arriello
  • Bayer Consumer Care AG
  • Bayer Medical Care BV
  • Bespak Europe Ltd
  • Boehringer Ingelheim BV
  • Celgene
  • Celgene Europe Ltd
  • Celgene International
  • Genzyme Europe BV
  • GSK
  • Imanova Limited
  • Magstim
  • Mercury Pharma Management Services Ltd
  • MSD AH Innovation GmbH
  • MSD Ltd
  • National Artificial Eye Service
  • Pharmacosmos A/S
  • Pharmaspec Specials
  • Procter & Gamble
  • Public Health England
  • Roche Products Ltd
  • Sanofi-Aventis R&D
  • SC Pharma Serv International Srl
  • Takeda Development Centre Europe Ltd
  • VESO Vikan
  • Vifor Pharma UK Limited

Excellent content, good speaker. Interacted with everyone.

Faiz Aziz, Technologist , Colorcon

Excellent speaker, good presentation and content.

Faiz Aziz, Technologist , Colorcon

Very good, interesting and enjoyable

Chris Martin, Quality Engineer, Remote Diagnostic Technologies Ltd

Pleasant, friendly, engaging and very knowledgable

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

It was well packaged, concise and to the point.

Bolutife Adeyemi, Senior PV Associate, GW Pharmaceuticals plc

Informative and engaging. Thoroughly enjoyed it

Malgorzata Wilinska, Research Associate, University of Cambridge

Excellent

Olga Vorobyeva, QMS Specialist , Arriello

Very good overview

Alexandra Beer, Senior Quality Manager, Animax Ltd

Enjoyable course, with a very good presenter.

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

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

Esther Janssen, Compliance Manager, Ferring Pharmaceuticals A/S

Useful course which I have definitely benefited from attending

Ken Barratt, Production & Quality Manager, The National Artificial Eye Service

Well thought through

Liz King, Director of Research and Development, Oxford Pharmascience

Very well put together and good use of group work. The course was very informative and used good examples for analysis. Good use of all participants present.

Jas Sangha, , Mundipharma Research Ltd

Was about right, good fun approach and professional delivery

Sandie Holmes, QA, Regulis Consulting Ltd

Accurate and exhaustive content, very interesting presentation, alive presentation without borrowing time

Karine Faller, Team leader QARA, Bernafon