About the Webinar
The ISPE’s Special Interest Group (SIG) on Validation 4.0 has been meeting since late 2019 to work on new approaches to ensure that Pharma manufacturing processes are fit for purpose to produce safe and reliable quality products. This webinar will contain extracts from the SIG’s work including:
An introduction to Validation 4.0 based on recent PE article: ‘Laying the foundation for Validation 4.0” including an explanation of the conceptual model that is being developed within the SIG.
The relevance of QbD and Pharma 4.0, using case studies on continuous verification for OSD manufacturing
About the Presenters
Dave Margetts is the CEO and co-founder of Factorytalk and focuses his advice, consulting and technical experience for clients in the Pharmaceutical and Biotech industries on quality, technology capability and process performance. Dave‘s background spans shop floor integration and control through manufacturing execution and quality management systems up to corporate operational improvement and regulatory compliance initiatives. He is responsible for leading the company and developing it’s vision and key people and he remains an active resource for our clients in both technical solutions and consulting roles.
Before moving to Asia in 2004 to start Factorytalk, he worked in systems and validation roles across one of Europe’s largest pharmaceutical production sites for AstraZeneca.
Michelle currently leads the Quality Practice at Tulip Interfaces, Inc, who develops and sells a frontline operations platform where manufacturers of many industries can build digital content to manage their operations. Before joining Tulip Michelle spent over 24 years in the biopharmaceutical and medical device industries in many different roles ranging from QC laboratory, engineering technical support, Quality Assurance management and Computerized Systems Compliance.
