0
  • No products in the cart.
Total:£0.00
,

Behavioural Good Manufacturing Practices (bGMP) & Human Error Reduction

Register Your Interest

This course is currently not scheduled however it can be delivered for your team. To register your interest, complete the form below

Register Your Interest

 

Register your interest in the course. When we schedule dates, we will be in touch.

By clicking register, you agree to our Privacy Policy

Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.

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 organisation’s culture
  • Improve your management skills in motivating and changing your team’s behaviour and culture

What is Included in a Live Online Course?

 

  • Direct access to an expert trainer.
  • Interactive and engaging sessions with exercises and discussions.
  • Bitesize learning.
  • Access to the Educo Life Sciences Training Portal.
  • Unlimited access to the recordings for 4 to 5 weeks after the last session.
  • A reinforcement session delivered 4 to 5 weeks after the course (online) providing you with extra time with the trainer.
  • A validated certificate of attendance is available for you to download.

Course Dates

 

Find out when this course is running so you can plan your training. Scroll down to view the full agenda.

Dates TBC

1 Week Live Online Training
Register at the top of the page.

Group Discount

 

If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.

 

For a quote, complete our contact form by following the link. Get in touch.

Customised Team Training

 

We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.

 

For more information, complete our contact form by following the link. Get in touch.

Free Online Module

 

  • Module 1 is free to attend and delivered online at a date 3 to 8 weeks before the full course start date.
  • To register for module 1, please submit your details in the form located in the agenda.
  • Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.

 

Full Course Information and Pricing

 

  • To attend the full course, you must register online at the top of the page by selecting the course dates from the drop-down and clicking enrol to add the course to your basket. Once added, please follow the checkout instructions to pay via credit card or bank transfer.
  • There are price tiers for this course. The dates of these are located above. The earlier you register the more you save.
  • The full training course is delivered either online or in a classroom. Please check which course format you have booked.
  • For hybrid training – In the event we do not have enough people on one of the options we will contact you to discuss switching.
  • For live online courses – The dates and times of modules/sessions are subject to change.
  • For live online courses – The module/session durations are approximate.

 

Frequently Asked Questions (FAQs)

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.

Categories: ,

Related products