How Digital Lab Assistants Can Improve GMP Data Integrity

Life Sciences, Pharma Manufacturing & Supply Chain, Laboratory Technology,
  • Thursday, June 11, 2020

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

http://Steffen%20Gloth,%20LabTwin

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.

Message Presenter
http://Cheryl%20Blasie,%20Bristol-Myers%20Squibb

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.

Message Presenter
http://Eric%20Cooksey,%20Karyopharm%20Therapeutics%20Inc.

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.

Message Presenter
http://Sofía%20Lange,%20Atrium%20Innovations

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.

Message Presenter

Who Should Attend?

Professionals in the following areas will benefit from this presentation:

  • Research Informatics
  • Quality Assurance
  • GMP compliance in Pharma
  • Quality Control
  • Digital Strategy

What You Will 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

Xtalks Partner

LabTwin

LabTwin is creating the next generation of digital lab tools for smart labs, starting with the world’s first voice-activated lab assistant. With LabTwin, scientists can collect data, access information, manage experiments and streamline documentation simply by talking. Using voice recognition and machine learning technology, LabTwin’s smart assistant simplifies data capture, structures valuable information, and provides suggestions to scientists in real-time so they can make more informed data-driven decisions. With a mission to empower scientists, LabTwin is backed by BCG Digital Ventures and Sartorius. Its voice-powered assistant is used by hundreds of scientists in leading biopharma companies and academic institutions around the world including Deutsches Primatenzentrum (DPZ), University Medical Center Göttingen, and the University of California, San Francisco.

Visit the website or request a demo to learn more.

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