Unified Quality, R&D and Laboratory Management with Real Time Monitoring
Assure Data Integrity

A Free FDAnews Webinar • Sponsored by Xybion
Thursday, Sept. 24, 2020 • 11:00 a.m. - 12:00 p.m. EDT

In this new all-digital world, you will need to always be ready for the eAudit, eInspection, eSourcing and eReporting processes proposed by the FDA. Predictive compliance and quality risk management will be key to a strategic future with connected processes, connected systems and seamless data.

Emerging biotechnology and fast growing small and medium specialty bio-pharmaceutical companies can avoid the historical legacy systems driven handicaps that large companies are experiencing by implementing a fully unified informatics and data management system covering all scientific R&D, quality, compliance and regulatory requirements all on a single cloud platform. This will avoid costly, inefficient replication of the old legacy systems and will allow cutting edge inventions fast forward to market with pro-active quality risk management required for faster FDA approvals. Mature bio-pharmaceutical companies now can now undertake to rapidly transform their existing legacy quality systems with a cloud based unified quality, R&D and laboratory management with real time data integrity monitoring on a single platform. This will allow all employees across global sites to efficiently work remotely with full compliance.

In this free webinar, Pradip K. Banerjee, Ph.D., Xybion’s chairman of the board and chief executive officer, will explain how you can accelerate digital transformation of your QMS platform to unify with R&D and laboratory operations and risk management to assure data integrity and real time monitoring of 21CFR Part 11 requirements.

Dr. Banerjee will be highlighting a cutting edge scientific breakthrough case story where a large ROI was achieved by implementing a unified QMS, R&D, LIMS, ELN and DMS on a single database in the cloud from the beginning.

Dr. Banerjee will help you answer these questions:

  • How can I have all of my information, data, quality and compliance needs on a single cloud platform?
  • How can I have a unified digital cloud having QMS, R&D, LIMS, DMS, RISK and real time data integrity management on a single data and process platform?
  • How to have a fully validated and compliant system in the cloud so that I don’t need to go through the slow process of computer system validation?
  • How can I get what I need for my quality functions without compromising my quality needs?
  • How can I create a strategic digital future workplace with proactive automated real-time compliance monitoring?

Be proactive: avoid the mistakes of implementing obsolete legacy QMS systems. Explore how you can rapidly transform into a unified data integrity platform. Register today.


Who Will Benefit

  • CEOs of biotech companies with advanced pipelines
  • Senior Compliance Leaders of pharmaceutical companies and generic drugmakers
  • Senior Vice President of Regulatory Affairs and Compliance, Risk Management and Quality
  • CIOs of pharmaceutical and biotech companies

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Meet Your Presenter

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Pradip K. Banerjee, Ph.D.

Chairman of the Board and Chief Executive Officer, Xybion

Pradip K. Banerjee, Ph.D. is Xybion’s chairman of the board and chief executive officer. He is the founding Managing Partner (retired) of Accenture’s R&D Line of Business. He is an entrepreneurial senior executive with more than 30 years of in-depth experience in the global life sciences, healthcare and services industries in operations, strategic management, business development, investments and new venture creations. Previously, he held several R&D management positions at Abbott, Glaxo-Smith Kline and also served as president and CEO of the Science Center in Philadelphia.