PDA New England Chapter Webinar: Pharma 4.0 Preventing Data Integrity Issues Through Digitization and Automation

This webinar will review warning letters and guidance documents which illuminate the root causes for data integrity issues. An analysis of risk reduction and control measures will show how paper-based systems are inherently less amenable to error prevention than automated systems. We will discuss how the pharma industry has systematically avoided using Big Data and which areas are already accessible and available. Digitization & automation can allow us to use predictive indicators for effective & real risk knowledge management.

Speaker Information:

Karen Ginsbury is a UK trained pharmacist with a master’s degree in microbiology, Karen has a passion for Quality. She believes the industry needs to stop pulling data manually out of batch records in order to perform quality reviews of retrospective data more than a year after its generation. We MUST use disruptive techniques and modernize the pharma industry. The way forward is USING big data…not just having it! Karen (pre-COVID) regularly lectured around the world using conferences and courses as an opportunity to poll participants & benchmark best practices.