Paperless Lab academy 2021 program

The PLA2021 is an opportunity for visitors and providers to connect in these time of limited travelling and business meetings

The event will take place on a virtual platform accessible from your browser and also downloadable as an app in your smartphone. 

Access to all recorded sessions to registrees is now closed only available upon request

WHAT WILL YOU LEARN 

  • About the future of the laboratory within the industry 4.0
  • Business decisions and companies’ processes supported by scientific data management
  • The relevance of a Master Data strategy for mastering your data
  • The reality of the #IoLT, Internet of Lab Things and #Ioi, Integration of instruments
  • How to apply the FAIR principles and secure your data
  • Why archiving is the beginning and not the end of a solid #eDataLifeCycle
  • Practical sessions on Audit trails, data integrity, and new Compliance guides
  • Demystification of the Cloud-based solutions
  • How to successfully implement laboratory system solutions

WHO SHOULD ATTEND

Industries that significantly benefit from the Paperless Lab Academy congress include: Pharmaceutical, Lab Services, Biotech, Food & Beverage, Consumer Goods, Cosmetic, Chemical, Oil & Gas 

People visiting us every year range from Laboratory Directors and Managers, Operational Excellence, IT Business Partners, QC, and QA Management, Research departments, and Manufacturing

ORGANIZATION WELCOME MESSAGE

roberto castelnovo paperless lab academyPresenting: Isabel Muñoz-Willery Ph.D. & Roberto Castelnovo, owners & organizers at NL42 Consulting | Paperless Lab Academy 

Isabel and Roberto are entrepreneurial persons involved in paperless laboratory processes projects. Coming from international managerial roles with strong domain knowledge in laboratory processes, laboratory automation, laboratory informatics, and project management, they launched their personal project, NL42 consulting,  by 2012.  Soon their own
customers were asking for better visibility of the industry solutions and learn about the latest technological trends and best-recommended methodologies.
Along the time, the Paperless Lab Academy® has become the platform where to find the answers. 

NL42 organiser Paperless Lab Academy

DIGITAL LAB HUMAN CENTRIC DESIGN. AN APPROACH TO ENABLE MODELLING & PREDICTIVE ANALYTICS - Vijay Raju | Novartis

Novartis Paperless Lab AcademyVijay Raju, Global Head of Analytical R&D at Novartis

Master Science in Chemical Engineering  from Mississipi State University and MBA from The Ohio State University Fisher College of Business. Vijay started his career as project manager at Boehringer Ingelheim before moving to Novartis. At Novartis, Vijay has pursue then a pathway to Director/Principal Fellow, Technical R&D, becoming Global Head of Analytical R&D (VP) by 2018 based Basel, Switzerland...

 

>> see more about the Digital lab at Novartis

INSTITUTIONAL ELN and LIMS DEPLOYMENT IN ACADEMIC RESEARCH - Nicolas Argento | EPFL

Nicolas Argento EFLP at paperless lab academyNicolas Argento, ELN/LIMS services manager at École Polytechnique Fédérale de Lausanne, EPFL

For the last 5 years, Nicolas has been transforming an ELN/LIMS project into a core service serving the research laboratories and technology platforms in an academic life sciences research institute. Focused on the added value for scientists and laboratory staff, he coordinated 55 LIMS implementations in a wide variety of laboratories. His team of 4 engineers ensure tailor made deployments, the maintenance and evolution of an in-house infrastructure. IT engineer by training, his previous experience was in IT project management in the banking industries. He decided to embrace an innovative training to specialised in IT for healthcare. Acting as a lead link between laboratories and IT departments, his expertise covers biology R&D, healthcare and telemedicine information systems as well as IT project and services management.

>> see abstract about Institutional ELN and LIMS deployment in Academic research

EPFL logo

INTERNATIONAL TRANSFERS of PERSONAL DATA and the IMPACT of Schrems II

Sofie van der Meulen, Senior Supervision Officer at the Dutch Data Protection Authority

Sofie works for the Dutch Data Protection Authority. In her position as senior supervision officer she focuses on privacy in the healthcare sector. Before joining the Dutch Data Protection Authority, Sofie has gained broad experience dealing with various kinds of legal issues in both profit and non-profit environments. In her previous position as attorney at law in the field of life sciences, Sofie specialised in legal and regulatory issues related to medicinal products and medical devices, with a special focus on medical software, big data and data protection.

 

THE RIGHT IMPLEMENTATION of an END-TO-END DIGITAL LABORATORY PLATFORM for GENERICS PHARMACEUTICAL DEVELOPMENT - Jernej Grmas | Sandoz

Sandoz paperless Lab academyJernej Grmas, Project Manager at Sandoz Development Center Slovenia, a Novartis Company

Jernej Grmaš is a Project Manager at Sandoz Development Center Ljubljana, a division of Novartis group developing generic pharmaceutical products. After graduation, he joined Sandoz in 2008 as a scientist in Analytical Development, becoming involved in the development of nasal spray products, a topic on which he completed his PhD study at University of Ljubljana in 2019...

 

 

>> see more about Sandoz digital lab platform project 

ACCELERATING NEW PRODUCT INTRODUCTION AND BATCH RELEASE TIMES USING EFFECTIVE DIGITAL TRANSFORMATION IN A POST COVID ERA - Mark Fish & Barry Heavey | Accenture

Barry Accenture Paperless Lab AcademyBarry Heavey Managing Director at Accenture’s Digital Manufacturing and Quality

Barry is a Managing Director based in Dublin, Ireland and leads Accenture’s Digital Manufacturing and Quality offering for life sciences in Europe. He has over 20 years of experience in the pharmaceutical industry and holds a PhD in Genetics from the University of Vienna.

 

Mark Fish Accenture Paperless Lab AcademyMark Fish, Managing Director at Accenture’s Scientific Informatics Services Business

Mark Fish is a Managing Director in Accenture’s Scientific Informatics Services Business. Mark has over 20 years of experience in various leadership roles delivering innovative solutions to the pharmaceutical sector and is passionate about drug discovery and development, translation research and precision medicine, digital transformation, agile software development and analytical quality control automation.

>> see abstract about Accenture live presentation

 

 

PAPERLESS LAB PROJECTS AND THE PANDEMIC: CHALLENGES AND BENEFITS OF RUNNING AN IMPLEMENTATION VIRTUALLY - Sinead Cowman | Lonza

Lonza at Paperless Lab academy 2021 Europe
Sinead Cowman, Global Business Development & Marketing Manager at Lonza Informatics

Experienced Business Development Manager with a demonstrated history as an informatics specialist for the Pharma and biotechnology industry. Skilled in QC Microbiology, Data Integrity, Verification and Validation (V&V), Good Laboratory Practice (GLP), Medical Devices, and Change Control. Graduated from University of Oxford - Said Business School.

LONZA PAPERLESS LAB ACADEMY

 

 

>> see more at LONZA goes live at #PLA2021Europe

DIGITAL & AUTOMATED SCHEDULING at GSK: BEFORE & AFTER - Jenna Gerber | GSK

GSK paperless Lab academyJenna Gerber, Quality Control Specialist Supervisor at GSK

Jenna has 10 year experience in the pharmaceutical industry as a scientist to now a quality control specialist supervisor at GSK, Philadelphia. She previously worked at PPD as scientist, project manager and then associate group leader. Jenna got her Bachelor of Science in Pharmaceutical Sciences the University of the Sciences in Philadelphia and master  and a Master of Science in Regulatory Affairs and Quality Assurance.

 

 

 

LEAN LAB PROJECT CHEMICAL & BIOCHEMICAL QC - Barbara Pirola | ESSECO & Roberto Rollini | Patheon


Barbara Pirola, director QA/QC at Esseco 

Barbara has about  20 years of experience in the Pharmaceutical field, FDA regulated
10 years in leadership roles: Quality assurance manager, Quality Compliance Manager, Quality Control Manager in the pharma services at Patheon and now at Esseco Srl. Enthusiastic manager who is recognised leader in driving Quality Culture and motivate teams to be best in class.  Clear goal vision and persistence in achievement by providing continuous improvement and problem solving attitudes.

 

 

Roberto Rollini, Sr Manager Practical Process Improvement, Operational Excellence at Patheon

Roberto considers himself a modern leader able to connect and to everyone at different level of the organisation. Very determined in achieving a mature lean status where Continuous Improvement is part of site’s day life. He is promoting  the culture of continuous improvement into the site making the change sustainable and effective. From formulation Development technician at Bracco, he moved to managerial roles in Sandoz, Mipharm, before dedicating his career to operational excellence at Patheon now part of ThermoFisher Scientific.

 

 

>> see more about the Lean Lab project at Patheon and Esseco

DIGITAL LAB IN A NUTSHELL - Daniel Juchli | Wega

Daniela Juchli Paperless Lab academy 2021 Europe

Daniel Juchli, Head of Lab & Research IT at wega Informatik AG, Switzerland and Chief Technical Officer at the SiLA Consortium

Daniel’s professional background is based on a dual qualification, as a chemist and as an IT professional. He has over 20 years of professional experience in both disciplines.
Daniel speaks both the language of scientists and IT experts and can translate between the participants in project teams. His life science knowledge enables him to bridge the gap between the needs of users and the technical possibilities of IT systems.He is an expert in leading projects for the development of laboratory automation and IT solutions in life sciences environments, such as research and development laboratories or QC laboratories in regulated environments.
Daniel joined SiLA in 2014 as a representative of SiLA’s supporting Member wega Informatik. Since then, he has been instrumental in the development of SiLA 2.

WEGA paperless lab academy

>> see more at WEGA goes live at #PLA2021Europe

WORKSHOPS SESSIONS  

PREMIUM: AGILAB WORKSHOP

LOGO AGILABDigital Unified Laboratory Platform: The benefits of a strong UX for R&D and QC processes

During the demo session areas covered are the overview of AgiLab’s powerful UI and how it drives the following processes: QC Product Lots, Stability Protocols, Method Execution, Equipment and Material Management and Booking, R&D Experiments (ELN) and Requests

>> see Agilab workshop abstract and more

PREMIUM: LONZA WORKSHOP & INTERACTIVE LIVE SESSION

LONZA PAPERLESS LAB ACADEMYPractical applications of Data Integrity and Audit Trail Review

The why, what, when, where, who and how of audit trail review. Learnings from this workshop will be: Regulatory requirements around audit trail review, Examples of audit trail review strategies, Roles for audit trail review.

>> see Lonza workshop abstract and more  

>> see more at LONZA goes live at #PLA2021Europe

PREMIUM: WEGA WORKSHOP & INTERACTIVE LIVE SESSION

Wega gold sponsor PLA2019Agile validation in GMP Projects

Onboarding a QA into the validation concept & Interactive live session
Meeting between the Validation Expert, the Vendor SME and the QA of the LIMS project. The QA is new and needs to take over the responsibility from his predecessor who left the company. He knows agile framework from the theory and has only supported classical V-model validation projects.
See how the Validation Expert and the Vendor SME explain him the agile project setup and the validation concept in order to get the commitment of the new QA for the project.  A subsequent Q&A session as the new QA has tons of questions and is challenging the new agile approach. This session will be interactive, allowing the audience to also ask questions, express their doubts and share experiences.

>> see more about wega workshop abstract 

>> see more at WEGA goes live at #PLA2021Europe

GOLD: ABBOTT WORKSHOP

LOGO ABBOTTA LIMS solution for Lab 4.0

Information technology has transformed the way laboratories operate through ever increasing degrees of automation. We have reached a point, where technology enables us to implement digital solutions that make paper reports completely superfluous for operating a laboratory while being fully compliant with ALCOA+ principles.

>> see Abbott workshop abstract and more

GOLD: BINOCS WORKSHOP

Optimize Your Lab Performance by Building the Digital Twin of Your Lab

Are you curious to discover the digital twin of your lab performance? What it looks like? You have probably seen a lot of theoretical models and abstract articles about it. In this workshop, we will make it tangible and build it up together with you.
Automated lab scheduling enables your team to move away from firefighting and allows it to work more efficiently and optimally.

>> see Binocs workshop abstract and more

GOLD: DASSAULT SYSTEMES WORKSHOP

How the cloud is revolutionizing the lab

Scientific organizations need to optimize operations by improving efficiency while maximizing quality and adhering to regulations, while driving innovation. Across product development and quality control domains, they are increasingly turning to cloud-enabled solutions to increase deployment flexibility, lower total cost of ownership, and maintain data security.

 

>> see Dassault Systèmes Workshop and more

GOLD: DEXSTR WORKSHOP

Inquiro from Dexstr: How the combination of Search and AI eases the digitalization process of life science companie

The amount of data available internally and externally is increasing at an unprecedented rate. Structured data (about 20% of all data) is historically well managed with solutions such as LIMS, ELN, SAR (Structure-Activity-Relationship) database, and many others. But how to effectively manage the remaining 80% of unstructured data (report, document, literature, patent, ...) and access and extract valuable information for the decision-making process [in life science companies]?

>> see DEXSTR workshop abstract and more

GOLD: EPPENDORF WORKSHOP

eppendorf logoYour Sample Goes Digital

Who’s not familiar with being lost in samples and processes? Clear labeling is recommended to make sample identification as easy as possible. Though all labs strive for this standard, you often find vessels in your freezer with illegible labels or without any labelling at all. One of the main reasons is that reliably cataloging samples is usually a painstaking and time-consuming task.

>> see EPPENDORF workshop abstract and more

GOLD: GILSON WORKSHOP

gilson paperless lab academyAutomation without the Robot

Manual pipetting is a fundamental lab skill. Even in labs where automation is present, pipettes are still critical for certain tasks — often ones that are either too routine or too dynamic to automate. See how Gilson’s TRACKMAN® Connected pipetting platform addresses this gap, providing the reliability, traceability, and reproducibility expected of automation — all in a simple, fast platform that fits in a backpack.

>> see Gilson workshop abstract and more

GOLD: INPHARMATIC WORKSHOP

Logo InpharmaticCollect your instruments in a unique platform and review data digitally

Discover an innovative platform able to:
Collect instrument measurement details, enriching them with all essential metadata: Date&Time, attributability, measurement context, sample ID…
Connect all your laboratory instruments to a unique repository, solving data integrity issues.
Drive the measurements through an approval workflow and review with Electronic Signature.
Reduce human errors, improving data reliability.
Increase efficiency, gaining time for quality.
Create a safe data flow between the lab and the business.
Generate reports based on data acquired, according to your needs.
Be smart, use Ioi wherever you are through Tablet, Smartphone, PC

>> see INPHARMATIC workshop abstract and more 

GOLD: LABFORWARD WORKSHOP

Smart labs: How to solve the connectivity puzzle

Laboratories are going smart, and the current pandemic accelerated that process. But what does smart really mean? For sure connectivity is important, but how to distinguish true connectivity from fake connectivity? And how to not only transform digitally on paper but also truly transform your lab and last but not least your people in the lab. To help you build a truly connected lab we created the ABC of smart labs: a checklist of what you should Avoid, Buy and Consider.

>> see LABFORWARD workshop abstract and more 

GOLD: LABWARE WORKSHOP

labware paperless lab academyHow the Internet of Lab Things, #IoLT, is changing the Laboratory World

More and more devices are including connectivity technology, allowing them to be part of a persistent network. This includes laboratory instruments such as balances. These instruments can become a seamless part of a laboratory’s Internet of Things (IoT) environment, allowing quick interfacing and simple usage. During this session, we will discuss the practical ways of creating an Internet of Lab Things (IoLT) environment, and the technical and regulatory challenges to be expected.

>> see LABWARE Workshop abstract and more

GOLD: MERCK WORKSHOP

Merck Paperless Lab AcademyHow FAIR Data Can Accelerate AI-Driven Drug Discovery

Unstructured scientific data is one of the biggest drains on productivity in the pharmaceutical industry today, at an estimated impact of €10 billion per year. In this talk we will explore the hidden costs that data silos and proprietary file formats have—from manual data-cleansing to compliance to enterprise-wide digital transformation.

 

>> see MERCK Workshop abstract and more

GOLD: PERKINELMER WORKSHOP

perkinelmer PAPERLESS lab academyDigital Transformation in R&D: the Signals Research Ecosystem

Research Scientists daily face the challenge that the science they are doing is complex and often generates a high volume and variety of data. In addition, they are spending too much time preparing this data and learning the tools to explore it vs the time they can spend on ideation and innovation. In this workshop we will present the PerkinElmer Signals Research Platform which is designed from the ground up to consider these challenges.

>> see PERKINELMER workshop abstract and more 

GOLD: THERMO FISHER SCIENTIFIC WORKSHOP

thermo fisher scientific at paperless lab academyFrom strategy to action: How to accelerate digital transformation

Scientific organizations are continuing the discussion around digital transformation, but the narrative is shifting from strategy to execution. Organizations are looking at how they can leverage scientific developments, technological advancements, and digital solutions to create an enhanced laboratory and increase productivity. Join our talk as we discuss the focus of Thermo Fisher Scientific’s digital solutions in driving industry evolution and helping our customer’s to prepare for the next set of digital transformation goals.

>> see Thermo Fisher Scientific  workshop abstract and more 

ACADEMY EXTRA: TOP 5 presentations from #PLA2020India

UNLOCK YOUR ANALYTICAL INSTRUMENT DATA FOR DATA SCIENCE & MORE - Andreas Steinle _ Roche Diagnostics

andreas Steinle roche diagnostics

Andreas Steinle, Manager Digital Solution at Roche Diagnostics GmbH

#Case Study #Data Transfer #FAIR principles #SCRUM #Cloud #GXP

Andreas Steinle is accountable for digital transformation in the analytic department of Roche Pharmaceuticals Technical Development Europa since early 2018.
Between 2005 to 2017, Andreas was head of the group “Analytical Systems” with the responsibility for support of validation of analytical systems and laboratory equipment (pH Meter, HPLC, LIMS, Archiving, etc.) in Roche Pharma Biotech Production in Penzberg.
In addition in this role he he was also responsible for the integration of laboratory equipments into enterprise systems and the representation to health authorities.

>> see the abstract about Unlock your analytical instrument data for data science 

 

roche logo transparent

ARE SPREADSHEETS A FAST TRACK TO REGULATORY NON COMPLIANCE?

Bob McDowall Paperless Lab AcademyPresenter: Bob McDowall,  director at R D McDowall Limited

#Chromatography #CDS #LIMS #ELN 

An analytical chemist with over 45 years’ experience including 15 years working in the pharmaceutical industry and over 25 years working for the industry as a consultant.  Bob has been involved with automating analytical laboratories since 1980 and was an early implementer of a Laboratory Information Management System (LIMS).

Bob is an auditor and he has been involved with the validation of computerized systems for over 30 years and is the author of books on the Validation of Chromatography Data Systems (two editions 2005 and 2017) and in 2019 published his book on Data Integrity and Data Governance - Practical Implementation in  Regulated Laboratories.

>> see abstract  about if spreadsheets are a fast track to regulatory non compliance 

DATA FORENSICS IN QC LABS: FROM DATA TO TRUTH

Mark Newton at Paperless Lab AcademyPresenter: Mark Newton, Principal at Heartland QA

#Data Integrity #Metadata #Chromatography 

Mark is an independent consultant who specialises in data integrity, laboratory informatics, computer systems validation, and Quality. He has 35 years of experience in the pharmaceutical industry in QC Labs, computer systems validation and lab informatics at Eli Lilly. Mark co-lead Eli Lilly’s data integrity remediation program for QC Labs worldwide in 2012, consulted and audited several Lilly sites preparing for data-integrity focused inspections.
Mark is a co-leader for the GAMP Data Integrity Special Interest Group and Chair of ISPE Global Documents Committee.
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.

>> see the abstract about data forensic: from data to truth 

DEFINE YOUR OWN PATHWAY TO PAPERLESS QC LABORATORY: Lessons learned from an ongoing project

Sergio Nasi Paperless Lab AcademyPresenter: Sergio Nasi, Head of IT Operations Laboratory Execution at Boehringer-Ingelheim

#LabInformatics #Paperless Processes #Systems Interface #Pandemic Situation  

Sergio has been in the laboratory informatics business since year 2000 and worked predominantly in the Laboratory Information Management Systems domain ever since, in several companies and under various roles: developer, consultant, business analyst, project manager and team lead. Having a passion for cats and technology, Sergio thinks that an innovation-driven pharmaceutical corporation and top player in the Animal Health business just seems the right place to be.
Boehringer Ingelheim logo
DIGITAL TRANSFORMATION IN THE CHEMICAL INDUSTRY -  THE DEVIL´S IN THE DETAILS

Lloyd Colegrove Dow ChemicalsPresenter: Dr. Lloyd F. Colegrove, Director of Data Services at Dow Chemical

#Industry4.0 #Artificial Intelligence #Digital Transformation Strategy #Change Management 

Lloyd F. Colegrove recently retired as the Director of Data Services and the Director of Fundamental Problem Solving within Manufacturing and Engineering. He was also the Analytics Platform Director for Dow’s Manufacturing and Engineering’s Industry 4.0 program. Lloyd’s background is in Chemical Physics where he obtained a B.S. and Ph.D. from Texas A&M University. He spent 7 years in Polymer Research in Dow (R&D and TS&D) before moving into Manufacturing in an Analytical Improvement role and then a Quality Leader for five Dow businesses before moving to help establish a new capability called Fundamental Problem Solving, where top chemists and engineers work on complex, often multi-effect, plant problems. With this established, he refocused his efforts working to establish the data initiatives that support this work. Lloyd is married with two daughters and is an avid cyclist, hiker and landscaper.

>> see more about Digital Transformation in the Chemical Industry. The Devil's in the Details.

Dow logo transparent

*agenda subject to changes