Quality Event Management Training
Quality Event Management is critical for organizations that are experiencing a wide variety of quality events requiring investigations. Many organizations get overwhelmed by the number of investigations they are conducting and tend to over-react in their level of effort by investigating every single quality event. This is often referred to as "Death by CAPA" or "Death by Investigation." Quality Event Management teaches how to identify, specify and prioritize the level of effort required based on risk.
Our Quality Event Management course helps organizations address the following key learning objectives:
- Establish appropriate channels to
accept quality events.
- Clarify a quality event using 5Ws
for understanding.
- Assemble necessary documentation
relevant to the quality event.
- Set the correct path forward for
evaluation and action.
- Notify and alert others who must act
now to resolve quality event.
- Assess levels of risk and escalate to
CAPA when needed.
AUDIENCE
Quality Event Management is a 2-hour course appropriate for individuals who are regularly called upon to resolve problems, or whose input would aid in preventing problems. Examples include investigators, laboratory, QA/RA functions, managers, manufacturing supervisors, technicians, and engineers. We also have a one day course specifically designed for Root Cause Analysis.
PathWise not only provides an outside perspective to these issues, we bring proven best-practices, tools, and processes. We’ve studied the best of the best in the life sciences field, and bring an intimate knowledge of regulations.
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Learn the basics of the event review process with our Event Review guide.
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