Drug Quality Risk Management

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NEWSFLASH: Failure Mode and Effects Analysis (FMEA) is NOT a risk management system.

Consider this quote from one of the FDA’s top quality experts:

“Are FMEA or FMECA… good tools? Yes. They are very good tools that can be utilized. Are they in and of themselves a risk management system? Absolutely not. I can’t tell you how many manufacturers I have seen that have tried to present their risk management system by simply presenting a FMEA — that is not a risk management system. Do not make the mistake of presenting FMEAs as your whole risk management system.”

FMEA has been called the “Swiss Army knife” of risk management. It’s useful for a host of jobs. But sadly, it’s typically the only tool pharma and biologics firrms use.

Register today.

Sometimes simple risk situations need only simple tools, while at other times the complexity of the situation requires to be more sophisticated or tailor-made. The key is using the right tool for the job.

If you want to move beyond FMEA and equip yourself with the right tools for the right situation, you must attend the 2017 Drug Quality Risk Management workshop.

Regulatory agencies around the world – US FDA, Health Canada, and authorities in Europe and Australia – expect you to use Quality Risk Management. The ICH Q9 guideline on Quality Risk Managemnet is useful but it doesn’t give details on how to use the tools or how to implement an effective QRM program.

Unsure about dynamic current state of Quality Risk Management and your compliance responsibilities? Join the crowd.

But you can get back on track. Come to Arlington Oct. 26-27, 2017, and discover how to bulletproof your quality management next time the FDA comes calling.

Announcing the onlyworkshop that lets you transform ICH Q9 theory into practice: Drug Quality Risk Management: Beyond FMEA — Developing a Comprehensive Risk Program.

Register today.

In two information-packed days, you’ll go from learning the basics of ICH Q9 to applying its subtleties. You’ll see how other firms approach the topic. You’ll use case studies and participate in role-playing exercises, small-group simulations and more, that will help you understand how to integrate Quality Risk Management into your operation.

Register today and you’ll see why 30-year industry veteran James Vesper, PhD is a noted management expert and an acclaimed, award-winning trainer.

Dr. Vesper will work closely with you for two full days, sharing proven risk management tools that can boost productivity and reduce risk, such as:

  • How to choose the right risk management team (critical if you want to control and mitigate risk)
  • 6 tools that gauge the severity of a failure event — HazOp, FTA and others 
  • Best practices for proactive decisionmaking — know when to accept and control a risk, or when you must eliminate it entirely
  • Establishing scales for severity, occurrence, and detection
  • Ways risk-based thinking can be integrated into your quality system
  • Updated strategies to prepare for risk-based inspections
  • 6 accident models that let you identify a hazard and its source — and help you to steer clear of common misconceptions that trip up many firms
  • Why a two-part risk assessment question is better, and how to create it


With the FDA leaning so heavily on a risk-based approach to judge the compliance of your product, does a reactive risk control scramble really make sense?

Be proactive. Tap into this workshop’s quality-by-design strategies and stop stressing over end-of-cycle batch quality.

Register your entire team today.

Of course, even an arsenal of effective risk management tools won’t help — unless you know how and when to use them in real-life situations.

And Drug Quality Risk Management gives you the power to do just that. In breakaway, mock risk management teams, you and a group of your colleagues work a series of interactive exercises and industry case studies — building “in the trenches” skills that include:

  • Heuristics and biases — experience for yourself ways that can distort how we think about and rate risks
  • Real-world hazard identification — consider potential sources of harm, relate back to situations you’ve encountered, then reveal your findings to the group
  • Risk estimation — establish a risk question to identify a specific harm, then measure the severity of its impact
  • Risk case studies — using an actual risk management example, you and your group detail risk evaluation results and report on probability
  • Mini presentations of risk assessment conclusions — you and your mock risk management team will document and share conclusions with co-attendees
  • Plus much, much more


Reduce risk. Avoid warning letters. Boost productivity. Build profits. And all while forging a wealth of industry contacts. Where? Drug Quality Risk Management: Beyond FMEA — Developing a Comprehensive Risk Toolkit.

Sign up today for the only workshop that lets you turn ICH Q9 theory into practice.