An exclusive Live Webinar
Approaching Digital Transformation:
How Biopharm Should Prepare for Validation and Compliance
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Data is critical for operations within the pharmaceutical and life sciences industries, whether it is for compliance, operational excellence, reporting or development. Data integrity enables convenience and trustworthiness in all types of data generated in several areas across the workflow. As more people, systems and tools consume data, it becomes increasingly valuable because it can be translated into action to improve quality and performance while reducing costs and time to market. However, with additional systems and users comes a risk that, if not managed correctly, can compromise the integrity of data.
Here is What You'll Learn
The importance for Data Integrity in Lifesciences
The impact of Digital Transformation in Lifesciences value chain
Understand how people are a key enabler in a Digital Transformation effort
Understand how culture can strengthen or weaken Data Integrity
Understand how a well-designed governance structure can support Data Integrity and embed Quality into a Digital Transformation
About Angela Bazigos
Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, a firm dedicated to providing expert compliance consulting and support services to pharma, biotech, medical devices, CMOs, and CROs. Angela is a co-author and prototype contributor of 21 CFR Part 11 guidance with the FDA. She continues to collaborate with the FDA on new guidance documents.
About Aaron Hubbell
Aaron is the East Coast Director for Delta Project Management, a life sciences consulting firm, where he is responsible for business strategy, client relations, team leadership, and consulting in the areas of Quality Culture, Training, and Data Integrity. Aaron has worked in biopharmaceuticals since 2000 and prior to joining Delta Project Management has held roles in Quality, Manufacturing Sciences, Operational Excellence, and Validation at CDMO and biopharmaceutical innovators.
About Shweta Nair
Shweta Nair is the Senior Product Manager, Biotechnology portfolio, at Advanced Instruments, a manufacturer of scientific analyzers that serves the biotech and pharma industries. The company recently launched a portfolio of osmometers that include data integrity features in support of 21 CFR Part 11 and EU Annex 11 compliance.