How Digital Lab Assistants Can Improve GMP Data Integrity

Good Manufacturing Practice (GMP) regulations require that companies maintain minimum standards for processes, equipment, facilities and quality management systems. However, it can be challenging to accurately record and track various data streams in real-time, within manufacturing facilities.

Voice-powered digital lab assistants provide a solution by directly communicating with lab instruments and by automatically transcribing voice notes from staff. Digital lab assistants ensure complete, accurate, contemporaneous data that can be easily attributed to staff members via user identification, automatic timestamps and electronic signatures.

Join a panel of industry experts in this round-table style webinar to learn:

• The importance and challenges of data integrity in a GMP environment
• How digital lab assistants help maintain data integrity, security and auditability
• How digital tools can facilitate real-time data-driven decisions and improve quality management

Speakers

Steffen Gloth, Co-Founder & Head of Operations, LabTwin

Steffen Gloth is a mechatronics engineer with more than a decade of successful experience in the biotechnology industry. Before co-founding LabTwin, Gloth served for over 12 years in various positions at Sartorius, where he helped empower scientists and engineers to simplify and accelerate their scientific progress. As a pragmatic and strategic thinker, Gloth is responsible for all business operations at LabTwin.

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Cheryl Blasie, Director of Analytical Quality & Compliance, Bristol-Myers Squibb

After obtaining a PhD in Chemistry from the Johns Hopkins University, Cheryl worked as a Senior Research Scientist at Centocor, a biotechnology company subsidiary of Johnson & Johnson before taking responsibility in the CMC program management. After a second experience in Promedior, another biotech company recently acquired by Roche, Cheryl started her now well-established career at Bristol-Myers Squibb. There, she has worked in CMC program management, biologics analytical compliance and specifications, early assets quality and compliance, and is currently working as the Director for Analytical Quality and Compliance.

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Eric Cooksey, Principal GMP Auditor, Karyopharm Therapeutics Inc.

Starting as a QA specialist at Bayer, Eric has since then developed an extensive experience in the quality arena of biotechs and pharmaceutical production, managing and implementing quality systems at Pharmavite, Dendreon, Vical and Peregrine Pharmaceuticals. He is today in charge of auditing CRO and vendors for Karyopharm Therapeutics who outsources its lab work, to ensure GMP compliance at each level.

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Sofía Lange, Head of QA, Atrium Innovations

With an education in Biochemistry and Quality Management, Sofía has more than 10 years of experience in GMP regulated environment in Pharmaceutical Industries (Parexel, Teva Pharmaceuticals, Atrium Innovations), from research experience, to analytical laboratory and manufacturing practice in QC and QA role. In her current position, she leads and drives the Quality Management System for the Berlin site of Atrium Innovations.

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