Research and Markets: Improving Processes and CAPA Course: London, 8th July 2014

DUBLIN--()--Research and Markets (http://www.researchandmarkets.com/research/5k334s/improving) has announced the addition of the "Improving Processes and CAPA (Course, London)" conference to their offering.

The Improving Processes and CAPA course will take place on 08 July 2014 at The Rembrandt Hotel, London

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 Improvements

- How to develop options for process improvement and CAPA

- Planning and implementation in practice of improvements and CAPA

In today's highly regulated Pharma, Device and Veterinary industries, it is essential to use the most efficient processes and ensure compliance with Corrective and Preventative Action (CAPA). Regulatory Inspectors are increasing reviewing responses to findings dealt with by the CAPA approach and process improvement.

It is highly likely that the organisations who have already been inspected will be assessed at 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 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.

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.

Certificates of Attendance for Professional Development will be given to each participant who completes these seminars

Key Topics Covered:

Introduction and Objectives

CAPA Methodology and Documentation

- Identification - clearly define the problem

- Evaluation - appraise the magnitude and impact, e.g. scenarios, test out assumptions (e.g. using the Uncertainty - Importance grid to 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 Questions and Close

For more information visit http://www.researchandmarkets.com/research/5k334s/improving

Contacts

Research and Markets
Laura Wood, Senior Manager.
press@researchandmarkets.com
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Sector: Healthcare and Medical Devices, Pharmaceuticals

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Contacts

Research and Markets
Laura Wood, Senior Manager.
press@researchandmarkets.com
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Sector: Healthcare and Medical Devices, Pharmaceuticals