Aims
To provide an introduction on the concepts of behavioural GMP and how they relate to human errors and incidents, as well as to develop methodologies for root causes analysis and failure investigation.
Outline Syllabus
- Practical basis for GMP rules – why compliance to GMP is critical
- Behavioural GMP – what it is, and how does it work in practice
- Sources of human error in manufacturing
- Role of the QA, Compliance and Production in problem solving and continuous improvement
- Identify and apply tools used to assist with failure investigation and root cause analysis (RCA)
- Classify deviations based on risk to compliance and product integrity
- Assess whether a deviation merits correction or corrective action(s)
Course Description
Behavioural GMP: Human Error Reduction
Ensuring your staffs are skilled and competent in the workplace is a fundamental requirement in the highly regulated life sciences industry. While understanding the GMP “rules” is important, the key is changing the actual behaviour and practices of personnel engaged in GMP-related activities. In this course, you will be introduced to new leading edge techniques that will engage personnel to think, act and change GMP-related behaviour in a compliance environment. Topics include:
- Practical basis for the GMP rules - why compliance to GMP is critical
- Role of the QA, Compliance and Production in problem solving and continuous improvement
- Behavioural GMP – what it is, and how does it work in practice
- Sources of human error in manufacturing
Behavioural GMP: Effective Root Cause Analysis and Failure Investigation
This course provides participants with current approaches to effective root cause analysis/failure investigation and deviation management. Participants will have the opportunity to work through practical examples. The course covers the following:
- Identify and apply tools used to assist with failure investigation and root cause analysis (RCA)
- Classify deviations based on risk to compliance and product integrity
- Assess whether a deviation merits correction or corrective action(s)
Learning Objectives
Upon completion of these workshops, participants will have gained an understanding of the sources of human error in manufacturing, how to use bGMP concepts to improve compliance and productivity and how to conduct effective root cause analysis/failure investigations. Participants will learn through interactive presentations, case studies and group activities specifically designed for optimum learning. On completion of this course, participants will be able to:
- Apply bGMP concepts to company GMP compliance and improvement
- State the main root causes for human error
- Identify cultural changes to minimise human error
- State the key reasons for deviations and failures
- Apply structured methods for failure investigation and root cause analysis
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