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.