Course description
Investigations and CAPA Training
Investigations and CAPA is continually the top 483 observation made by the FDA each year. For Medical Devices the FDA cites 21 CFR 800.100, where “procedures for corrective and preventive actions have not been established.” For drugs, the FDA cites 21 CFR 211.192, where there is a “failure to view investigations.” The PathWise Investigations and CAPA Training course is designed to meet the requirements mandated by world regulatory bodies.
The CAPA training helps you investigate problems in a quality system. We use an interactive approach to show how to effectively apply risk-based methodology throughout the investigation process. As a result, course attendees will be ready when problems occur, and ready to prevent future problems. Specifically, we focus on how you identify issues. Additionally, we instruct how to assess and prioritize these issues, or non-conformances. Finally, we cover how to investigate to root cause, and implement corrective and/or preventive actions. Ultimately, our investigations and CAPA course will reduce repeat CAPAs, and improve root cause identification.
Upcoming start dates
Who should attend?
Investigations and CAPA Training is appropriate for individuals in biomedical, pharmaceutical, medical device or biologics. Specifically, for those who are regularly called upon to resolve problems. Additionally, those whose input would aid in preventing problems.
Examples include: investigators, laboratory functions, QA/RA functions, managers, and manufacturing supervisors.
Training content
The PathWise Investigations and CAPA training course covers four modules. These modules explore the following learning objectives:
- Identify and distinguish between a correction, corrective action and preventive action.
- Assess concerns and evaluate risk.
- Investigate events.
- Gather specifics
- Assess impact
- Make a risk-based decision
- Conduct root cause analysis.
- Systematically find cause(s)
- Establish causal relationships
- Use quality tools: 5 Whys, Fishbone, IS/IS NOT
- Identify a process to verify root cause.
- Identify a process to implement corrective/preventive actions.
- Develop an implementation plan
- Deliver results according to the plan
- Check output effectiveness
- Perform closure activities
Why choose PathWise?
Founded in 1998
4000+ classroom learners every year
Over 10,000 users of online courses
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PathWise
In a globally regulated life science industry, PathWise provides proven methodologies in quality and compliance through hands-on and practical solutions that ensure compliant, effective, and efficient quality systems. PathWise focuses on a solutions-based approach to solving client issues. We help...
Reviews
Average rating 4.9
There were so many good things [in this course]! The most beneficial was how to use risk assessments to approach investigations and actions
It gave a lot information and steps that can be utilized while investigating and generating reports.
This course gave me the opportunity to learn when, why and how to apply the different tools and steps involved in performing a successful CAPA.