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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.

27 Sep 2022

& 13 Dec 2022 , 27 Apr 2023 , 18 Jul 2023 , 15 Dec 2023

Book or reserve now

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 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.

Book now

Book or reserve now

NEW higher discounts for booking multiple places - bring your colleagues to make your training budget go further:
30% off the 2nd delegate; 40% off the 3rd delegate; 50% off the 4th delegate

Choose your date below - or reserve your place with no obligation for 7 days at ipi.academy: Reserve now
27 Sep 2022
Live webinar
09:00-17:00
UK (London)
27 Sep 2022
Live webinar
09:00-17:00
UK (London)
GBP 599 499
EUR 859 719
USD 970 814
Until 23 Aug*
Enrol now
to attend Live webinar
13 Dec 2022
Live webinar
09:30-17:00
UK (London)
13 Dec 2022
Live webinar
09:30-17:00
UK (London)
GBP 599 499
EUR 859 719
USD 970 814
Until 8 Nov*
Enrol now
to attend Live webinar
27 Apr 2023
Live webinar
09:30-17:00
UK (London)
27 Apr 2023
Live webinar
09:30-17:00
UK (London)
GBP 649 549
EUR 929 789
USD 1,049 893
Until 23 Mar 23*
Enrol now
to attend Live webinar
18 Jul 2023
Live webinar
09:30-17:00
UK (London)
18 Jul 2023
Live webinar
09:30-17:00
UK (London)
GBP 649 549
EUR 929 789
USD 1,049 893
Until 13 Jun 23*
Enrol now
to attend Live webinar
15 Dec 2023
Live webinar
09:30-17:00
UK (London)
15 Dec 2023
Live webinar
09:30-17:00
UK (London)
GBP 649 549
EUR 929 789
USD 1,049 893
Until 10 Nov 23*
Enrol now
to attend Live webinar

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. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.

Continuing professional development

This course qualifies for 6 hours for your CPD records.
More about CPD

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.

Contact us

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Previous customers include...

  • Menarini Ricerche S.p.A.
  • Actavis A/S
  • Actelion Pharmaceutical Ltd
  • ADAMAS Consulting Ltd
  • Bayer Consumer Care AG
  • Bayer plc
  • Boehringer Ingelheim Ilaç Tic. A.S.
  • Bray Group Ltd
  • Celgene International Sarl
  • Chiesi Farmaceutici SPA
  • Chiesi SA NV
  • DA Consulting Ltd
  • DHLSupply Chain
  • Ewopharma International s.r.o
  • Goldenzone Ltd
  • Idorsia Pharmaceuticals Ltd
  • Industrias Farmaceuticas Almiral S.A.
  • Intervet International BV MSD Animal Health
  • LEO Pharma A/S
  • MSD Ltd
  • Novo Nordisk Ltd
  • Philips Respironics
  • Pierre Fabre Medicament
  • PrimeVigilance Zagreb d.o.o.
  • Sanofi Pasteur MSD Ltd
  • Sanofi-Aventis R&D
  • SC Pharma Serv International Srl
  • Sharp Life Science (EU) Ltd
  • Teva UK Ltd
  • Zoetis

Very informative and clear

Christine Meilak Mercieca , Senior Quality Associate , Orphalan Ltd, Jun 22

My overall opinion of this webinar is that, the content was informative and included several important aspects of the relative subject. It was well presented and as clear as possible by the speaker. When questions were asked, the speaker cam back with the respective adequate answers.

Davinia Cardona, Document Controller, Orphalan Ltd., Jun 22

It was a pleasure to meet Laura Brown. She was very knowledgeable about CAPA and explained in a simple way all the steps to understand the CAPA process.

Oscar Ortego, Export Veterinary Auditor , Food Standards Agency, Dec 21

Great session, thank you

Kasia Stathers, Vigilance Officer , Reckitt Benckiser Group , Jun 21

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+, Jun 21

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

Fiona Kermode, Panacea Pharma Projects, Dec 20

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

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