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SP6435/7 Behavioural GMP: Minimising Human Error and Failure Investigation (Two half day workshops)

One of the greatest losses in productivity is managing manufacturing deviations. (1)

When a deviation occurs, processing may stop, product is held up, time consuming investigations are required and ongoing GMP non compliance raises risks. Most deviations originate initially from human error and recur due to lack of effective failure investigation. Attend these workshops and learn about how to minimise human error and how to effectively investigate failures.

(1) Pharmaceutical Manufacturing Research - Georgetown/Washington University 2006

Who Should Attend

These workshops have been specifically designed for Managers and Supervisors who are responsible for implementing or maintaining GMP Compliance and Quality Assurance in the manufacture of human or veterinary therapeutic products. Managers and supervisors who are responsible for reducing deviations and conducting failure investigations will particularly benefit. You should enroll if you have an interest in:

• Quality Assurance and Compliance
• Operational Improvement
• Continuous Improvement
• Human Error Reduction
• Failure Investigation

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 top 10 reasons for deviations and failures
• Apply structured methods for failure investigation and root cause analysis

Course Content

Morning Workshop: SP 6435 – bGMP and Human Error Reduction

Leveraging your investment in effective training is a smart business principle. Ensuring your staff are skilled and competent in the workplace is also 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 these workshops, 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 (using industry examples)
• 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
• Group exercise: brainstorming, cause and effect relationships regarding GMP impediments
  

Afternoon Workshop: SP 6437 – Effective Root Cause Analysis and Failure Investigation

A recent industry survey highlighted that the #1 cause for loss of pharmaceutical productivity was the ineffective management of deviations. This workshop 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 workshop covers the following:

• Review and revise their company deviation management system for 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)
• Apply these concepts to some workshop examples

Course Fee

Participants are encouraged to attend both workshops however can opt to attend either.

Single workshop: $325 + gst

Both workshops: $550 + gst

A 7.5% discount applies for 3 or more participants from one company.