Falls Church, VA (PRWEB)
September 22, 2017
Drug Quality Risk Management:
Beyond FMEA — Developing a Comprehensive Risk Toolkit
**Presented by FDAnews and Valsource Learning Solutions **
Oct. 26-27, 2017 – Arlington, VA
Early bird pricing for Drug Quality Risk Management ends on Friday, Sept. 29.
The types and severity of risk drug manufacturers must manage continues to increase. First, there is the struggle to consistently apply quality risk management principles to drug development, manufacturing, distribution, and inspection and submissions review processes.
Plus, an effective risk management program requires multiple levels of management buy in, innovative managers that are trained appropriately, a comprehensive strategic plan, and consistent execution. That’s a lot to manage so it’s no surprise drug manufacturers, like everyone else managing risk, continue to struggle.
Many drug manufacturers rely on FMEA, sometimes called the “Swiss Army knife” of risk management, as a useful tool to manage risk, but experts say that’s not enough. The complexity of most situations requires a set of tools to manage risk.
FDAnews and world class risk management expert Jim Vesper are proud to present Drug Quality Risk Management: Beyond FMEA – Developing a Comprehensive Risk Toolkit.
At this two-day workshop attendees will learn how to create a drug quality risk management strategy, and how to build a roadmap to get their companies to apply risk management principles.
But this isn’t some theoretical discussion, highlighted with dull PowerPoint slides.
A series of interactive exercises and case studies to walk attendees through real-world examples, and give them the tools needed to apply principles right away.
Exercises and case studies include:
- Two-minute talk — Exchange ideas with colleagues about how they define risk.
- Ranking risk —Attendees will be given a list of risks and asked to rank them in order of probably causes of death. This will gauge the perception of risk versus peers.
- Real world hazard identification — Work with a smaller group to consider product characteristics and the potential sources of harm, then relate them…