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

3 Dec 2019

& 26 Jun 2020 , 4 Dec 2020

GBP 699 599 *
EUR 979 839 *
USD 1,090 934 *
* When you book before 24 Oct

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.

We are also running

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

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 (e.g.‘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
  • Evaluation of the attractiveness/likely difficulty of changes (“AID” analysis)
  • Continuous improvement teams – an invaluable approach for improving the implementation of regulatory change

Planning and implementation in process of improvements and CAPA

  • Project managing process improvements and CAPA
  • Managing the change and people issues
  • Managing the stakeholder involved (stakeholder analysis)

Final discussion

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

3 Dec 2019
3 Dec 2019 Rembrandt Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
GBP 599.00
EUR 839.00
USD 934.00
Until 24 Oct*
Enrol now
26 Jun 2020
26 Jun 2020 Rembrandt Hotel, London
+ VAT @ 20.00%
Online registration unavailable: this date is nearing full capacity; please call us on 020 7749 4730 to register.
4 Dec 2020
4 Dec 2020 Venue not yet confirmed
+ VAT @ 20.00%
Enrol now

* Note the early booking discount cannot be combined with any other offers or promotional code

You may also be interested in

Previous customers include...

  • ADAMAS Consulting Ltd
  • Allergan Limited
  • Animax
  • Bayer plc
  • Biogen
  • Celgene
  • Celgene Europe Ltd
  • Celgene International Sarl
  • Cipla Ltd
  • Colorcon
  • Colorcon Limited
  • Daiichi Sankyo UK Ltd
  • DHL Hospital Logistics Centre
  • DHLSupply Chain
  • Idorsia Pharmaceuticals Ltd
  • Institute for Energy Technology
  • Intervet International BV MSD Animal Health
  • Merck KGaA
  • National Artificial Eye Service
  • Novartis Vaccines & Diagnostics SRL
  • Novo Nordisk Ltd
  • Pfizer Limited
  • Regulis Consulting Ltd
  • Sharp Life Science (EU) Ltd
  • Takeda
  • Takeda Pharma A/S
  • UCB Pharma SA
  • University of Cambridge
  • Vifor Pharma UK Limited
  • Zambon S.p.A.

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

Very clear, friendly and knowledgable.

Claire McGuinness, Medical Research Chemist, Mexichem

Very good.

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

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

Useful course which I have definitely benefited from attending

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

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

Esther Janssen, Compliance Manager, Ferring Pharmaceuticals A/S

Enjoyable course, with a very good presenter.

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

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

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

Karine Faller, Team leader QARA, Bernafon

Was about right, good fun approach and professional delivery

Sandie Holmes, QA, Regulis Consulting Ltd