About This Workshop

This highly interactive workshop provides you with the tools and techniques to improve your decision-making skills and better protect your company and the patient.

You will get practical experience running a risk meeting. We also show you how to take a structured, risk-based approach to problem-solving and decision-making, using techniques such as failure mode effect analysis (FMEA), Hazard Analysis and Critical Control Point (HACCP), the 5 whys and fishbone diagrams. You will practice resolving real-life scenarios and case studies using these tools. We also give you decision-making checklists and process flows to use in the workplace and teach you how to turn data into information. In short, we provide you with the skills and tools to make better decisions at work!

Why You Should Attend

Managers with responsibility for managing risk should attend this workshop to ensure they are equipped to assess a variety of risks and make decisions on priorities and mitigating actions. The workshop helps participants realize it is not possible to do everything.  It will also provide the tools to help make the right decisions to ensure resources are spent on the most important activities. These tools can then be utilized directly within participants own companies.

Key Learning Objectives

By the end of this workshop, you will:

  • Understand how to apply ICH Q9 routinely and in times of crisis in the workplace
  • How to use decision making tools such as FMEA, 5 whys and fishbone diagrams
  • Have experienced a risk committee in action

Workshop Outline

Risk-Based Decision Making – The Theory

  • Practical implementation and use of ICH Q9
  • Good decision-making practices (reactive and proactive)
  • FMEA and HACCP
  • Force field analysis, fishbone diagrams and many more techniques

How to Investigate and Make the Right Risk-Based Decision Relating to Some Common Scenarios

  • Product release: What do you do with the imperfect batch? Release or reject?
  • Stability test failures
  • Product recalls and customer complaints
  • Deviations and CAPAs
    • How to assess critically and identify CAPAs that are effective in preventing recurrence of the issue
    • How to handle deviation incidents
    • What to do when you can’t find root cause
    • How to prevent deviation overload
  • Procedural non-compliances: How to assess risk and prevent recurrence

Who Should Attend

  • Managers responsible for managing risk across a wide range of functions such as procurement, manufacturing and quality
  • Professionals who wish to improve their decision-making skills

Course Tutors

Darren Jones - In industry and from within the MHRA Inspectorate, Darren has seen the best, the worst and the indifferent – his unique perspective provides a gold standard of insight into this field. He is an expert tutor whose range of case studies is peerless. Learn from someone who has lived in your shoes.

Lynne Byers - An Executive Director at NSF, Lynne has wide experience in managing risk. In her career she has managed risks from regulatory inspections as both a regulator and VP for quality of suppliers and external supply in two major multi-nationals. In addition, she has proactively managed risk management processes within companies.