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
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
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 find out more call Customer Services on +44 (0)20 7749 4730 or e-mail info@management-forum.co.uk
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:
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.
Why is CAPA important?
CAPA methodology and documentation
Diagnosing process improvement
Developing options for process improvement and CAPA
Planning and implementation in process of improvements and CAPA
Final discussion
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.
| 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 |
| 26 Jun 2020 | |||
| 26 Jun 2020 | Venue not yet confirmed | + VAT @ 20.00% |
Online registration unavailable: this date is nearing full capacity; please call us on 020 7749 4730 to register. |
“Excellent content, good speaker. Interacted with everyone. ”
Faiz Aziz, Technologist , Colorcon
“Excellent speaker, good presentation and content. ”
Faiz Aziz, Technologist , Colorcon
“Pleasant, friendly, engaging and very knowledgable ”
Diana Kalmoni-Hassay, Reports, Submissions and Compliance Associate, GW Pharmaceuticals plc
“Informative and engaging. Thoroughly enjoyed it ”
Malgorzata Wilinska, Research Associate, University of Cambridge
“Very good, interesting and enjoyable ”
Chris Martin, Quality Engineer, Remote Diagnostic Technologies Ltd
“It was well packaged, concise and to the point.”
Bolutife Adeyemi, Senior PV Associate, GW Pharmaceuticals plc
“Very good overview”
Alexandra Beer, Senior Quality Manager, Animax Ltd
“Excellent”
Olga Vorobyeva, QMS Specialist , Arriello
“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
“Enjoyable course, with a very good presenter. ”
Sophie Thompson, Quality Engineer, Wesley Coe (Cambridge) Limited
“Was about right, good fun approach and professional delivery”
Sandie Holmes, QA, Regulis Consulting Ltd
“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
“Well thought through”
Liz King, Director of Research and Development, Oxford Pharmascience
“Accurate and exhaustive content, very interesting presentation, alive presentation without borrowing time”
Karine Faller, Team leader QARA, Bernafon