Benastrum

Over the past ten years, more guidance has been developed to assist firms in establishing their alert and action levels, enabling environmental and utility monitoring programs to become more established and standardized.  However, the majority of monitoring programs focus primarily on adherence to the established limits and trending of all data points to establish control of the target environment or utility.  In most cases, especially highly-engineered systems, OOS results are sporadic and do not form a clear trend among the entire data set (which is good as it shows the system is in-control).  In reality, the nonconforming data can provide more value to the company when trended on its own.

This live and comprehensive web seminar will focus on the importance of trending nonconforming environmental data in the pharmaceutical, biotechnology, IVD and medical device industries. Serving as a very practical solution-providing source and centering around a test-case data set, this course will assist participants in learning the value of examining trends in OOS data, as well as how to trend and interpret the data.

Key Discussion Points will include:

• What if a few samples come back OOS?
• Is it really important to look at the OOS trend?
• How can I start to gather information?
• What should I do with the data set once I have it?
• Who should I share the information with?

Learning Benefits:

Upon completion of this course, participants will have a better understanding of:

• the frequency of review
• who should review
• which systems should be reviewed
• how to trend
• how to analyze
• the interpretation of trends
• what to do with knowledge
• the value to your organization