DATE: February 21, 2018
TIME: 8:00AM PST, 11:00AM EST

One report suggests that an average pharmaceutical manufacturing plant spends around €40M per year on quality control¹. At the same time another report states that 79% of all 483 Warning Letters issued by the FDA in 2016 cited 21CFR part 11 data integrity issues². Whilst re-training is a common response to an FDA 483 Warning Letter, this may be only part of the solution: was the problem simply that the worker(s) didn’t understand the SOP correctly, or was it really that the SOP is not robust enough to prevent future recurrences of the problem? Any process that automates the quality control SOP can potentially both reduce the impact of human error on data integrity issues and also bring welcome savings by reducing the time technicians need to devote to carrying out the SOP. This presentation takes a look at some common quality control procedures and how automation can help improve data integrity by reducing opportunities for human error, whilst at the same time potentially reducing operating costs.

Learning Objectives:

• Learn how automating quality control testing can reduce costs

• Learn how 21CFR part 11 compliance can be improved by automating quality control testing

• Learn how re-training is only part of a CAPA response to a regulatory inspection finding