Develop the skills and techniques to conduct more effective investigations of quality incidents and identify ways to reduce the likelihood of recurrence.
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 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.
Those who conduct, review, or approve investigations in development, quality assurance, laboratories, operations, technical services, and maintenance/engineering.
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