Presented by
Management Forum

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.

3 Dec 2021 + 3 more dates

Enrol now

  • Format: Live online, Classroom
  • CPD: 6 hours for your records
  • Certificate of completion

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.

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The CAPA (Corrective and Preventative Action) course will cover:

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)

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Laura Brown

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.

More details

Book CAPA (Corrective and Preventative Action) Live online/Classroom training

3 Dec 2021

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 11144

  • GBP 499 599
  • EUR 719 859
  • USD 814 970

Until 29 Oct

In your basket 

28 Jun 2022

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 11673

  • GBP 499 599
  • EUR 719 859
  • USD 814 970

Until 24 May

In your basket 

20 Sep 2022

Classroom
London venue TBC

09:00-17:00 UK (London)
Course code 11943

  • GBP 599 699
  • EUR 839 979
  • USD 934 1,090

Until 16 Aug

  • 1 day classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

In your basket 

13 Dec 2022

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 11798

  • GBP 499 599
  • EUR 719 859
  • USD 814 970

Until 08 Nov

In your basket 

Reviews of IPI's CAPA (Corrective and Preventative Action) training course


Great session, thank you

Jun 29 2021

Kasia Stathers
Vigilance Officer , Reckitt Benckiser Group

Jun 29 2021

Really useful refresher on CAPA and the processes used. It has helped me prioritise and categorise CAPA types, and I found particularly useful the section on risk scoring and utilising the risk register for those classified as minor.

Claire Crewe
QA Maanger, JensonR+

Dec 4 2020

I thought that giving the difficult situation with remote training it was well run.

Fiona Kermode
Panacea Pharma Projects

Dec 3 2019

A very talented speaker.

Mario Mohos
Quality Supervisor, Mylan Hungary Kft

Dec 3 2019

Excellent.

Hannah Allende
Assistant Clinical Trials Manager, University Hospitals Plymouth NHS Trust

Jun 29 2018

Excellent content, good speaker. Interacted with everyone.

Faiz Aziz
Technologist , Colorcon

Jun 29 2018

Excellent speaker, good presentation and content.

Faiz Aziz
Technologist , Colorcon

Dec 4 2018

Very clear, friendly and knowledgable.

Claire McGuinness
Medical Research Chemist, Mexichem

Dec 4 2018

Very good.

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

Dec 4 2018

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 7 2017

It was well packaged, concise and to the point.

Bolutife Adeyemi
Senior PV Associate, GW Pharmaceuticals plc

Dec 7 2017

Pleasant, friendly, engaging and very knowledgable

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

Dec 7 2017

Informative and engaging. Thoroughly enjoyed it

Malgorzata Wilinska
Research Associate, University of Cambridge

Dec 7 2017

Very good, interesting and enjoyable

Chris Martin
Quality Engineer, Remote Diagnostic Technologies Ltd

Jun 30 2017

Excellent

Olga Vorobyeva
QMS Specialist , Arriello

Jun 30 2017

Very good overview

Alexandra Beer
Senior Quality Manager, Animax Ltd

Dec 6 2016

Useful course which I have definitely benefited from attending

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

Jul 1 2016

Was about right, good fun approach and professional delivery

Sandie Holmes
QA, Regulis Consulting Ltd

Jul 1 2016

Well thought through

Liz King
Director of Research and Development, Oxford Pharmascience

Jul 1 2016

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

Dec 6 2016

Enjoyable course, with a very good presenter.

Sophie Thompson
Quality Engineer, Wesley Coe (Cambridge) Limited

Dec 6 2016

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

Esther Janssen
Compliance Manager, Ferring Pharmaceuticals A/S

Jul 1 2016

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

Karine Faller
Team leader QARA, Bernafon

UK

  • Torbay Pharmaceuticals
  • A.Menarini Farmaceutica Int SRL
  • Abbott Healthcare Products Ltd
  • Abbott Laboratories Ltd
  • ADAMAS Consulting Ltd
  • Allergan Limited
  • Animalcare
  • Animax Ltd
  • Arnold & Porter (UK) LLP
  • Associates of Cape Cod Inc
  • AstraZeneca
  • AstraZeneca R&D Charnwood
  • AstraZeneca UK Ltd
  • Bayer Healthcare
  • Bayer plc
  • Besins Healthcare Pharma Services
  • Bespak Europe Ltd
  • Biogen
  • BOC Micro applications centre
  • Bray Group Ltd
  • Carclo Technical Plastics
  • Celgene Europe Ltd
  • Chesapeake Pharmaceutical & Healthcare Packaging
  • Chiesi
  • Colorcon
  • Colorcon Limited
  • DA Consulting Ltd
  • Daiichi Sankyo UK Ltd
  • Depuy CMW
  • DHL Hospital Logistics Centre
  • DHLSupply Chain
  • Eisai Europe Limited
  • Food Standards Agency
  • Goldenzone Ltd
  • GSK
  • GW Pharmaceuticals
  • GW Pharmaceuticals Limited
  • GW Pharmaceuticals plc
  • Imanova Limited
  • Interport Ltd
  • Ipsen
  • JensonR+
  • KPMG
  • Magstim Company Ltd
  • Mercury Pharma Management Services Ltd
  • Mexichem
  • Morningside Healthcare Limited
  • MSD Ltd
  • Mundipharma Research Ltd
  • Necessity Supplies Ltd
  • Novo Nordisk Ltd
  • Nutricia Ltd
  • Owen Mumford Ltd
  • Oxford Pharmascience
  • Panacea Pharma Projects
  • Pfizer Limited
  • Pharmaspec Specials
  • Philips Respironics
  • Procter & Gamble
  • ProductLife Limited
  • ProductLife Ltd
  • Public Health England
  • Rayner Intraocular Lenses Ltd
  • Reckitt Benckiser Group
  • Regulis Consulting Limited
  • Regulis Consulting Ltd
  • Remote Diagnostic Technologies Ltd
  • Roche Products Ltd
  • Sanofi Pasteur MSD Ltd
  • Sekisui Diagnostics (UK) Ltd
  • Sharp Life Science (EU) Ltd
  • Takeda Development Centre Europe Ltd
  • Teva UK Ltd
  • The Magstim Company Ltd
  • The National Artificial Eye Service
  • Torbay Pharmaceuticals
  • University Hospitals Plymouth NHS Trust
  • University of Cambridge
  • Vifor Pharma UK Limited
  • Wesley Coe (Cambridge) Limited

Switzerland

  • Actelion A Janssen Pharmaceutical Company of Johns
  • Actelion Pharmaceutical Ltd
  • Bayer Consumer Care AG
  • Bernafon
  • Celgene International
  • Celgene International Sarl
  • F. Hoffmann-La Roche Ltd
  • GSK Consumer Healthcare S.A
  • IBSA SA
  • Idorsia Pharmaceuticals Ltd
  • Merck Serono SA
  • Novartis Consumer Health SA
  • Skan AG

Belgium

  • Chiesi SA NV
  • EORTC
  • Genzyme Flanders NV/SA
  • IBA
  • International Bar News
  • Ion Beam Applications SA
  • Keyrus Biopharma
  • s.a. Lundbeck nv
  • SGS Belgium NV Life Science Services
  • UCB Pharma SA
  • Words & Science

Denmark

  • Actavis A/S
  • Boehringer-Ingelheim Danmark A/S
  • Copenhagen HIV Programme
  • Ferring Pharmaceuticals A/S
  • H. Lundbeck A/S
  • LEO Pharma A/S
  • Neurodan A/S
  • Novo Nordisk A/S
  • Pharmacosmos A/S
  • SSI Diagnostica
  • Takeda Pharma A/S

Germany

  • AWD Pharma GmbH & Co KG
  • Bayer Pharma AG
  • Berlin-Chemie AG
  • Medac GmbH
  • Merck KGaA
  • MSD AH Innovation GmbH
  • Mundipharma Research GmbH & Co Kg

Italy

  • Menarini Ricerche S.p.A.
  • Actelion Pharmaceuticals Italia Srl
  • Alfa Wassermann S.p.A.
  • Alfrapharma Srl
  • Chiesi Farmaceutici SPA
  • Novartis Vaccines & Diagnostics SRL
  • Zambon S.p.A.

Netherlands

  • Astellas BV
  • Bayer Medical Care BV
  • Boehringer Ingelheim BV
  • Genzyme Europe BV
  • Intervet International BV MSD Animal Health
  • Janssen Biologics BV
  • Zoetis

France

  • ALEXION Europe SAS
  • Institut de Rercherches Internationales Servier
  • Pierre Fabre Medicament
  • Sanofi Pasteur Siege mondial
  • Sanofi-Aventis R&D

Hungary

  • EGIS Pharmaceuticals PLC
  • Mylan Hungary Kft

Israel

  • Roche (Israel) Pharmaceuticals
  • TEVA

Norway

  • Institute for Energy Technology
  • VESO Vikan

Romania

  • Ewopharma AG
  • SC Pharma Serv International Srl

Slovak Republic

  • Ewopharma International s.r.o
  • Ewopharma International, s.r.o.

Spain

  • Industrias Farmaceuticas Almiral S.A.
  • Laboratorios CINFA

Turkey

  • Boehringer Ingelheim
  • Boehringer Ingelheim Ilaç Tic. A.S.

Croatia

  • PrimeVigilance Zagreb d.o.o.

Czech Republic

  • Arriello

India

  • Cipla Ltd

Slovenia

  • Salus, Veletrgovina, d.o.o

Sweden

  • CTC Clinical Trial Consultants AB

Ukraine

  • SmartlineGroup

United States of America

  • Celgene

Enrol now

Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy