One Day Improving Processes and CAPA Seminar - London, United Kingdom - December 6, 2016 - Research and Markets

DUBLIN--()--Research and Markets has announced the addition of the "Improving Processes and CAPA (Corrective and Preventative Action)" conference to their offering.

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 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 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.

Agenda

CAPA Methodology and Documentation

- Identification - clearly define the problem

- Evaluation - appraise the magnitude and impact, e.g. scenCAPA 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 (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 Discussion

For more information about this conference visit http://www.researchandmarkets.com/research/sbv4hh/improving

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Medical Devices, Industry Standards, Production and Quality Management

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Medical Devices, Industry Standards, Production and Quality Management