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2022 ISPE Annual Meeting & Expo

SES201b - Quality 4.0- Revolutionizing the Role of Quality

Nov 1, 2022 10:45am ‐ Nov 1, 2022 12:15pm


The pharmaceutical industry, like all industries, is being swept inextricably forward on the digital tidal wave - where the flood of data will continue to transform and underpin the future of the industry. Successful companies will be the masters of these seas – where technologies to collect large volumes of data and automate practically every segment of the pharmaceutical value chain are now mature and quickly becoming common. And where newer data analytics and artificial intelligence technologies are quickly becoming realistic tools to revolutionize how the industry distills new value out of the rising sea of available data. Data integrity, like clean water, will be paramount to survive. Quality organizations will need to make strategic shifts in process and approach and skills and mindset, and redefine how data is used to sustainably and efficiently achieve the quality mission. New paradigms will be required to sustainably achieve data integrity, demonstrate compliance and assure product quality.


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