Behavioural Good Manufacturing Practices (bGMP) & Human Error Reduction

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Course Overview

 

A GMP environment is highly regulated and compliance driven, however mistakes do happen! Even in a regulated environment such as pharmaceutical manufacturing with well written SOPs, human errors and mistakes will occur. Over time this can be incredibly costly to your business.

 

This training course on behavioural GMP will teach you strategies, tools and techniques to identify, manage and mitigate errors. It will also support leaders in developing their skills in motivating and driving a cultural change to ensure a more efficient and cost-effective approach to GMP.

 

With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver live online training.

Key Learning Objectives

  • Assess the current cultural status of your organisation and understand how implementing a bGMP approach could increase efficiency and reduce errors.
  • Discuss tools that can be used to identify, manage and mitigate error
  • Understand the risk of human error and develop strategies for reducing it
  • Learn approaches for implementing a bGMP approach into your organisations culture
  • Improve your management skills in motivating and changing your teams behaviour and culture
Post Learning Implementation Plan (PLIP)

Pre-course

  • Access to the Educo Training Portal
  • Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

  • At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

  • Delivered 3 to 4 weeks after the training
  • It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges
Module 1

Introducing Behavioural Good Manufacturing Practices (bGMP)

  • Current and future GxP requirements
  • Understanding why current approaches to compliance management often don’t work
  • How can a bGMP approach support your compliance management

 

Module 2

Risk Based Compliance

  • Looking at the application of a risk based approach
Module 3

Organisational Culture & PIMS Culture Audit

  • How to assess the current cultural status of your work force

 

Understanding, influencing and managing change

  • What can we do to influence the performance of our teams and others around us?
Module 4

Changing behaviours

  • How can we implement and manage change?
  • Values based behavioural change

 

Mistakes Happen

Module 5

Understanding error

  • Understanding the different models of error and those that apply to our own organisation

 

Managing and mitigating error

  • Discussion about the tools available for mitigating and managing error

 

Module 6

Human risk

  • How do we assess human risk factors?

 

Mistake Proofing

  • Poka Yoke concept of how to mistake proof processes
Module 7

Investigating error – bbCi approach

  • Looking at different investigative techniques including the black box CAPA investigation concept designed to identify true root cause human error

 

Behavioural competencies for compliance

  • Aligning improvement to role profiles (competence and competency)

 

Module 8

Role of a behavioural coach

  • Defining the roles and responsibilities
  • Motivational techniques to change the behaviours of your team

 

Planning a bGMP change programme

  • Developing a bGMP action plan aligned with your organisation’s objectives

 

bGMP toolkit

  • Tools to support the cultural change

Brian Szukala has over 30 years of industry experience and currently supports life science organisations with learning and development, performance enhancement and change management around compliance areas and topics. He has a wealth of experience in the field of compliance and has presented at numerous seminars, both in the UK and abroad on various compliance, behavioural and productivity improvement topics.

 

Prior to this Brian was Business Services Director at SeerPharma providing auditing, consultancy and training for the life science sector a role he took after holding the role of Head of Training at Pfizer and Abbott Laboratories in the UK.

 

He has been actively involved in developing competence and competency frameworks incorporated into performance management systems. He has worked with various government bodies to advise on UK skills issues within the industry and is currently on the strategic board of SEMTA (Sector Skills Council representing pharmaceuticals) advising on skills and UK competitiveness.

This course is aimed at professionals who are responsible for GMP compliance or are leading manufacturing/production teams. These include: Management or Leadership | Qualified Persons | Quality Assurance | Quality Control | Senior Management | Compliance and Training Manager.

Could your team benefit from this course?

We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.

For more information you can email us at [email protected] or call +44 (0) 203 111 7357.

Or please summarise your objectives by completing the form below.

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• The training course is delivered either online or in a classroom. Please check which course format you have booked.
• For live online courses, dates and times of modules are subject to change
• Please contact us for the module dates of future deliveries.
• For live online courses, module durations are approximate.