An exclusive Live Webinar

Approaching Digital Transformation:

How Biopharm Should Prepare for Validation and Compliance

Hosted by
Advanced Instruments
ahubbell ,
Shweta Nair and
Angela Bazigos

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July
23
Thursday
July 23rd
12:00 pm EDT


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

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

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

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.

July
23
Thursday
July 23rd
12:00 pm EDT