On Demand Webinar – The Importance of Digitalizing Pharma and Biopharma Laboratories
Why Digitalize Your Laboratory? Learn More about the Inherent Business Benefits and Increasing Regulatory Expectations
プログラム概要
- Why pharma and biopharma laboratories should increasingly digitalize their laboratories
- The key business benefits that such digitalization brings – not only to the laboratory but to the entire company's value chain
- The increasing regulatory expectations in relation to automation and digitalization, such as, those within the forthcoming EU GMP Annex 11
- The value of knowledge management, with ICH Q10 as guidance
Pharma and biopharma companies stand to benefit enormously from the increased digitalization of their laboratories.
On the one hand there are substantial benefits in terms of time, accuracy, better trend analysis, and faster release of product from Q&A labs, for example, and on the other hand digitalization is increasingly expected by various regulators.
As a case in point, two particular proposals within the updated EU GMP Annex 11 highlight that:
- there is an increased expectation of advancements in data integrity, ideally using technical solutions and automation and
- an expectation of overall digital transformation within laboratories.
Gunnar Danielson of METTLER TOLEDO will delve into these topics with two keynote experts - Peter Baker and Bob McDowall.
Speakers
Peter Baker
Peter Baker spent 11 years working as a US FDA Drug Investigator and was the FDA`s Investigator of the Year in 2013. He has substantial experience in uncovering serious breaches in data integrity and has a special interest in big data management and compliance with Annex 11/21 CFR Part 11. Peter now works as an independent consultant helping companies to improve the quality of medicines through good data management.
Bob McDowall
Bob is an analytical chemist with over 50 years of experience in the pharma and life sciences industry. In particular, he has over 35 years of experience in automating laboratories and providing consultancy and validation advice about laboratory computerized systems and informatics, especially LIMS and CDS.
Gunnar Danielson
Gunnar Danielson leads METTLER TOLEDO`S software solutions business development team while having a core focus on digitalizing laboratories and on systems integration. Drawing on his 25 years in computer systems and business, Gunnar has extensive experience in laboratory workflow automation and data integrity. He also contributes regularly to evolving industry standards and regulatory conversations.
