FDAnews Announces: Drug Quality Risk Management: Beyond FMEA — Developing a Comprehensive Risk Toolkit, Oct. 26-27, 2017, Arlington, VA
Falls Church, VA (PRWEB) July 19, 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
http://www.fdanews.com/drugriskmanagement
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 back to actual situations and share the findings with the group.
• Risk estimation activity — Groups will establish a risk question to identify a specific hard, use a scale and find the probability and severity of its impact.
• Probability case study — Using a real world case study, attendees will learn how to detail the results of a risk evaluation and report on the level of probability.
• Mini-presentation of risk assessment conclusions — Review and evaluate a case study in mock risk management teams to correctly document and communicate all risk assessment conclusions and share the results.
This is event is focused on real-life examples, to provide attendees with the skills needed to apply risk management principles back at the office.
The exercises will be led by Jim Vesper, Senior Director at Valsource Learning Solutions, who designs and develops instructional courses and workshops for the pharmaceutical and medical device industries. Since 1991, he has been creating innovative instructional training products for drug companies, creating integrated curricula for personnel and customized training courses targeted to specific needs. Jim has 29 years of experience in the pharmaceutical industry, including 11 years at Eli Lilly and Company where he worked in Corporate Quality Assurance. He was responsible for issues concerning the manufacture and testing of parenteral products made by Eli Lilly facilities and third parties worldwide. His last assignment was as Project Leader of GMP education and Instruction, establishing the department and its mission.
Who Will Benefit:
• Auditors
• QA/QC personnel
• R&D management
• Compliance officers
• Executive management
• Laboratory management
• Risk management specialists
• Regulatory/legislative professionals
• Manufacturing directors and supervisors
• Validation specialists, scientists
Conference Details:
Drug Quality Risk Management:
Beyond FMEA — Developing a Comprehensive Risk Toolkit
**Presented by FDAnews and Valsource Learning Solutions **
Oct. 26-27, 2017 – Arlington, VA
http://www.fdanews.com/drugriskmanagement
Tuition:
Early Bird (until Sept. 29): $1,597
Regular Price: $1,797
Significant team discounts are available.
Easy Ways to Register:
Online: http://www.fdanews.com/drugriskmanagement
By phone: 888-838-5578 or 703-538-7600
About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
Michelle Butler, FDANEWS, http://www.fdanews.com, +1 (703) 538-7665, [email protected]
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