Statistical Experimental Design - the Keystone to QbD

Guest Speaker: Andy Tallevi, Keller Consulting

Description: April 2008 - It’s a well-known fact that the pharmaceutical industry, sadly, lags behind many other industries when it comes to process control and automation. There are many examples of lower tech industries that have made huge strides in this area and are producing high quality products, very low rejects and close-to-zero process failures. FDA and other regulators have supported and encouraged the adoption of Quality by Design. There can be no doubt that pharmaceutical manufacturers must have this as their aim. At the core of Quality by Design is one supposition: process understanding. Without this it is not realistic to assume one can control, let alone automate, a process. One must understand what the critical factors that affect the process are, what the limits of failure for each factor are and what the feasible limits of control for each factor are. This talk will discuss how to achieve process understanding using statistical design. It will also discuss how the use of PAT tools such as effusivity will ensure Quality products are produced.

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