Course Overview

  • “Excellent insight into problem solving and assessing risk. Buzz groups challenging, backing up the theory. Great learning environment.” Davis Harvey / Reckitt Benckiser, UK

A highly interactive 2 day course designed to provide you with the tools and techniques to improve your decision making skills and better protect your company and the patient. We will show you how to take a structured, risk-based approach to problem solving and decision making, using techniques such as A3 worksheets, RAPID decision making, Ishikawa, FMEA, and HACCP. You will practice resolving real life scenarios and case studies using these tools to great effect. We will 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 will provide you with the skills and tools to take better decisions at work!

About This Course

This course focuses on how to make the right quality decision in tough situations with finite information, short deadlines and high pressure!

It shows you how to use ICH Q9 (Quality Risk Management) in times of crisis, in times of unpredicted variation and also in times when quality planning is required.

Utilizing a range of scenarios across the common pharma dosage forms, the course is jam-packed with real-life GMP non-conformances, product quality concerns, customer complaints, change control requests, ‘uncontrolled’ variations, potential market actions and field alerts – helping you to see how to make more effective risk-based decisions at your workplace.

Life is rarely black and white, and it is those situations in the grey zone where your powers of risk identification, risk assessment, prioritization, execution and post-event verification are really tested. Taking a structured approach to decision making is critical in proposing the best ‘next steps’ and on this course you will spend time practicing a proven approach, evaluating your decisions and learning how to deal with a range of issues that challenge the quality attributes of pharma products.

Hindsight tells us that the wrong decision (or no clear decision!)at the wrong time can make or break a company or its supply chain. Some scenarios may only present themselves once or twice in a career, so attending this course concentrates a range of tough scenarios into two intensive days where we present some proven tools and then work alongside you to resolve several typical product quality issues.

What Would You Do About The Following?

  • You manufactured a batch with unapproved materials but QC test results are fine.
  • You have a choice of supplier. One cheap, the other less so. Which one do you choose? Why?
  • Your maintenance is overdue on top of an odd calibration failure. Thoughts?
  • Which contractors do you audit more frequently than others?
  • If you have limited engineering resource where must you focus?
  • Your regulatory inspector leaves you with a list of things to fix. Where do you start?
  • You’re designing a new plant. What are your priorities?
  • What signatures can you remove from the batch record to make it simpler? Some? Lots?
  • Your HVAC fails during manufacture (product contained). Do you carry on or stop?

First fact of life: Risk is everywhere.
Second fact: If you want to succeed and prosper you must have excellent risk-based decision making skills!
Thirdly: Avoid ‘gut feel’ decisions or worse still, no decision at all!

Key Learning Objectives

Your Return on Investment

We don’t believe in ‘death by PowerPoint’. We want you to learn, be engaged and have fun as well. Carefully designed case studies, teamwork tasks and problem solving exercises (facilitated by highly experienced course tutors) will ensure that you ‘learn by doing’. You will learn:

  • How we humans make decisions. We are actually conditioned to think quickly, not accurately! This course will transform your decision making processes
  • How to design a simple, structured decision making process that will give you the right answers to the biggest challenges most of the time
  • How to use ICH Q9 proactively in your decision making and in response to deviation, unexpected events and crises
  • How to use risk-based decision making proactively to prevent problems, simplify systems, add value and minimise risk
  • How to use the common risk-based decision making tools, practice their application and in doing so turn data into useful information

You will practice your decision making skills on a wide range of scenarios. Exercises (customized to meet your needs) will allow you to practice the tools and techniques so that by the time you leave you are ready for even the toughest decisions.

Course Outline

Risk-Based Decision Making – The Theory:

  • Practical implementation and use of ICH Q9
  • Good decision making practices (reactive and proactive)
  • Failure Mode Effect Analysis (FMEA) and Hazard Analysis Critical Control Point (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
  • Raw materials: Management of out of specification and out of trend results
  • Environmental monitoring excursions (viable and non-viable particulates)
  • Utilities: What to do when your water and HVAC systems ‘crash’!
  • Management and risk assessment of packaging related ‘mix-ups’
  • Cross-contamination incidents: What to do when you find the unexpected
  • Warehousing and distribution: How do you manage those temperature excursions?

We provide an optional post-course assessment that verifies proficiency of all course attendees.

Course Tutors

Course tutors will be selected from the following:

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 insight into this field. An expert tutor whose range of case studies is peerless. Learn from someone who has lived in your shoes.

Vice President at NSF, John has wide experience in preparing sites for regulatory GMP inspections, preparing or remodelling biopharma and steriles facilities, installing quality systems and helping companies embed the right culture for long term sustainable growth. A passionate educator, John has a fine track record of improving service and margin; to ensure perpetual GMP inspection readiness.

Eric has held senior positions in microbiology, validation, quality assurance and regulatory compliance in many major companies, also acting as EU qualified person. He has extensive experience with the MHRA inspecting plants manufacturing sterile products.

Rob has worked in the pharmaceutical industry for over 30 years and has great experience in preparing sites for regulatory inspections and driving continuous improvement. Rob is a QP and specializes in supporting organizations in systems development and implementation, mentoring, staff development, training and process mapping.

Other Dates and Venues for this Course

For other dates and venues for this course, visit our course calendar

Course Fees

Course cost (excluding VAT)  £1,580.00


Early bird and multiple delegate booking discounts available. Discounts also offered to NHS staff, regulators,
charities and some self-funding individuals – contact us for details.

Have a question or want to book a place? Contact - you can also register online by clicking below.