A new initiative within the Paperless Lab Academy framework
With this webinar program we are looking for maintaining the momentum created during the event editions and leverage the educational and learning aspects of this European platform.
Want to contribute?
Should you have any case study to share the experience gained along your company digitalisation, automation project...
Should you be willing to share your expertise on any related topics to the laboratory informatics...
the PLA is your platform
Setting the stage for a successful Digital Transformation project
Roberto Castelnovo, Owner at NL42 Consulting and Paperless Lab Academy
Master degree in Computer Science from Milan University, Roberto has worked almost 30 years in the area of laboratory information management and built a large experience in managing complex sales and services organizations to provide solutions at international level. During the majority of his professional career, he has been dealing with complex environments, partnering with product managers, marketing team, R&D and quality at global level and had opportunity to work in multi-cultural and global environments, travelling intensively throughout Europe, Middle East, Africa, Asia and United States.
Roberto will share with the audience his experience in driving successful projects. When it comes to digital transformation projects that aim for flawless paperless laboratory processes a good preparation is key. Such preparation requires considering several parameters such as change management, scope, technical and users requirements, business priorities and corporate commitment.
This webinar is an excellent opportunity to learn more on the topic. #digitaltransformation #paperlessproject #lessismore
NL42 is an independent consulting firm which provides specialized services dedicated to paperless projects, specifically focused in the areas of operations, quality assurance and quality control.
In 2016, NL42 has acquired the rights of the International Event Paperless Lab Academy which takes place yearly in different European locations.
A journey from data, through DATA, to BIG DATA
May Roca Statistical Manager - Continuous Improvement - Manufacturing Analytics at Dow Chemical Company
Ms. Roca has shared her experience at the Paperless Lab Academy 2018, and her presentation has been acknowledged as one of the most interesting about data analytics. We have now a new opportunity to travel the journey of her company discover their very latest conclusions in managing data.
“Your data talk to you. Do you listen ? Do you understand their meaning and take actions according to them? The organisations tend to underestimate the power of their data while generating and storing them. I like sharing what we do at Dow Chemical. In the last past years, we have been able to obtain successful results working intensively in bigdata along different areas of the company. Dow is a Chemical Company setting the stage for good data analysis program in any industry ”
This webinar is an excellent opportunity to learn more on the topic. #dataanalytics #bigdata
Dow combines the power of science and technology to passionately innovate what is essential to human progress.
The Company is driving innovations that extract value from material, polymer, chemical and biological science to help address many of the world's most challenging problems, such as the need for fresh food, safer and more sustainable transportation, clean water, energy efficiency, more durable infrastructure, and increasing agricultural productivity. Dow's integrated, market-driven portfolio delivers a broad range of technology-based products and solutions in high-growth sectors such as packaging, infrastructure, transportation, consumer care, electronics, and agriculture.
Qualification of Analytical Systems for Regulated Laboratories
Mark Newton, principal at Heartland QA
Mr. Newton is an independent consultant with 30+ years of experience in pharmaceuticals as a laboratory scientist, then as a QA professional, supporting LIMS systems, standalone lab instruments, lab informatics and metrics, validation, quality systems, and data standards. Mark has been deeply involved in data integrity audits and data integrity training to people in QC Laboratories, Manufacturing, and IT.
Mark is also an important contributor at the International Society for Pharmaceutical Engineering.
- Current Chair of the ISPE Global Documents Committee
- Current co-leader of the ISPE/GAMP Data Integrity Special Interest Group
- Co-author for “GAMP Guide: Records and Data Integrity” April, 2017
- Co-author of "Harmonizing USP <1058> and GAMP for Analytical Instrument Qualification" Schuessler, Newton, Smith, Burgess, McDowall. Pharm. Engineering, Jan/Feb 2014
- Co-editor of the GAMP Good Practice Guide "A Risk-Based Approach to Compliant Computerized Laboratory Systems" Nov. 2012
The webinar will cover the qualification and validation of analytical equipment, from requirements through purchase, installation, verification, maintenance and retirement. It will draw on the GAMP Good Practice Guide for Laboratory Computerized Systems (2nd ed) and USP<1058> Analytical Instrument Qualification.
#validation #CSV #riskmanagement #GAMP #USP