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Ways to conduct better investigations and corrective actions
Problems like deviations and failures are a fact of life but individuals and organizations that understand what happened and why are in a much stronger position to establish corrective actions to reduce the likelihood that the event happening again.
This course will help you develop the skills and techniques to conduct more effective investigations of quality incidents and identify ways to reduce the likelihood of recurrence.
- Discuss the expectations that GMP regulatory authorities have of investigations, CAPAs, and investigation reports.
- Differentiate between six different accident/incident models and how they can be applied during an investigation.
- Differentiate between root cause, contributing cause, and proximal cause.
- Discuss why human error is not a valid root cause.
- Given an incident, develop an investigation plan.
- Discuss the relationship between root, contributing, and proximal causes to corrections and corrective actions.
- Discuss a model that can be used to illustrate multiple layers of control and mitigation.
- Using a guideline, evaluate an interview.
- Identify four different audiences of investigation reports and what each is expecting to see in an investigation report.
- Discuss options of what can be done when a definitive root cause cannot be identified.
- Given an investigation report with deficiencies, identify ways to improve the report.
This two-day workshop examines a defined, logical process that can be applied to investigations that are performed in the drug, biotech, and medical device industries. Tools like data collection sheets, checklists, and interview worksheets, based on some of the best practices in the pharma industry and beyond, and provided and used. A variety of problem solving, interviewing, and data collection techniques will also be examined.
"Human error" will be discussed along with ways to more fully understand what really caused or contributed to the incident and how those factors can be effectively addressed.
Participants will also have the opportunity to see the importance of a team approach when doing an investigation. Teams will review and critique an investigation report and discuss risk-based alternatives when a definitive root cause cannot be determined.
When attending a Key2Compliance® course, you get access to Gate2GMP®, our document library and search tool.
Those who conduct, review, or approve investigations in development, quality assurance, laboratories, operations, technical services, and maintenance/engineering.
The price of this course is 15.280 dkk excl. VAT.
Early bird price: 13.780 dkk excl. VAT.
Key2Compliance® er et uafhængigt internationalt netværk, der tilbyder kurser og produkter til forskellige funktioner i Life Science-branchen, fra udvikling til marked med hensyn til kvalitetssystemer og GMP-overholdelse. Ved at hjælpe organisationer med at imødekomme GMP / QS-forventninger, forbedre arbejdsstyrkens viden...
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