Quality by Design (QbD) & Paperless Lab Consultancy
Making Informatics Work Across Your Teams
Academy 2015

MANAGE THE LABORATORY CHANGE PROCESS



 

Publications Peter Boogaard
  New scientific data consumers are increasing the value of laboratory. Managing change in the laboratory to deliver more value. Many research, manufacturing and regulatory procedures have been unchanged for years. There is an urgency to revisit these. The need to integrate the legacy silo based departments is becoming a top priority agenda item in many boardrooms.
It is pure waste to perform labour-intensive hunting for information across multi-vendor, multi-technique databases, manual transcription checking and to manually create reports. What are these challenges to create value for the consumers of the laboratory data?
When considering data integration, we must first stop thinking ‘technology’. Integration is not just about instruments or other software platforms. Instead, it is about integrating processes, accelerating ideas and facilitating mandatory compliance requirements more economical
The power of a Paperless Laboratory is the ability to enable organizations to implement self-documenting processes that produces GxP-compliant documentation which eliminates unnecessary tasks from the workflow, to result in a significant cost of non-compliance to support corporate Cost of Goods Sold (COGS) optimization.
Headaches about upgrading your software? Considerations for software expansions and upgrades. Before you decide to rock the boat, several key decision-making steps can help to ensure a smooth and successful upgrade. The last thing to do is to start is a project to change a working enterprise application environment.
It is time to put more emphasis on the preventing facet and re-order the sequence of the CAPA abbreviation into PACA. It is proven that his theory to adopt continuous improvement strategies to decrease variability resulted in significantly better products and financial performance.
For years, other industries, including the automobile, aviation and food & beverage industries, have adopted, very successfully, the Six Sigma QbD philosophy. An introduction how informatics will drive Pharma development towards Quality by Design.
Food companies are becoming pharma companies. Developing pro-active approach adapting QbD as a standard model and implementing new tools such as PAT, KQI and CQA  will leverage learning’s from both industries. Agile processes integrating “intelligent Equipment” will result in a new system-landscape allowing a seamless dataflow from start-to-end

    Full program booklet Media coverage Foto Impression
 Day 1  14th April 2015  Workshop details Sponsors / Suppliers  

Chairman's Welcoming Address
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P.J. Boogaard - CEO
Industrial Lab Automation 

Managing Change to Maximize Value
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Patrick Pijanowski - Partner, Pharma & life Sciences
LabAnswer 

Advancing Analytical & Pharmaceutical Development at Bayer Pharma: Optimizing systems & processes to achieve more effective laboratory operations
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Christian Wolf - Head of GCPD (Global Chemical & Pharmaceutical Development) Operations IT Systems
Bayer Pharma
Can Bluetooth simplify laboratory instrument integration?
TRENDWATCH DISCUSSION
Case study: elimination of paper in a Pharma company
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Juan Granados - IT Director
Farmasierra
The impact of ergonomics and lab layout on adoption and use ability of scientific software
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Dr Paul Denny-Gouldson - Vice President Solution Strategy
IDBS

Big Data in Drug Discovery: Implementation of Dotmatics’ Browser for data querying and visualization
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Jean-François Fournier - Unit Manager Lead Optimisation
Galderma R&D Medicinal Chemistry
Sophia Antipolis/France
Managing R&D data for Biomarker Discovery
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Nicolas Goffard - Bioinformatics Platform Manager
Enterome Bioscience
ELN Implementation Case at Formulation Departments
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Albert Irles - Business Technology Project Manager
Pere Guiro - Head of Pharmaceutical Technology
Almirall S.A.
Building an Open Framework to Address the Data Management Problems Facing the Analytical Laboratory
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Rachel Uphill - Data Provisioning Business Consultant
Allotrope Foundation - Glaxo Smith Kline
Deploying a commercial off-the-shelf Environmental Monitoring solution for Global manufacturing in a FDA/EMEA regulated environment with vendor provided documentation
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Terry McMahon - LIMS Specialist / QC Supervisor
Hologic
Is SAP QM able to consolidate LIMS in regulated pharma?
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Thomas Wolff - Managing Director
Labvisory UG
Big Data: new data structures for a new concept of regulated manufacturing
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Toni Manzano - ISPE España
Pep Gubau - ISPE España
de Bigfinite

  Workshop session 1A
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Workshop session 1B
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Workshop session 1C
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Workshop session 1D
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   How vendors can assist customers manage complex Lab Informatics applications Building a framework for change management Find Efficiency Killers
Multi Moment Analysis for reshaping IT Landscapes
New technologies for automated self-documenting instrument software integration

Workflow implementation in the laboratory
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Steffen Gloth - Product Manager for High Performance Balances and Individual Solutions
Sartorius
Improving the impact of data through the use of data analysis, modelling and reporting
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Colin Gray - Senior Specialist Scientist
SEPA (Scottish Environment Protection Agency)
Automation/Workflow Optimization in Discovery DMPK
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David Hand - Research Informatics
Merck Serono
Delivering Scientific Data Anywhere using the AnIML Data Standard
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Burkhard Schaefer - President
BSSN Software GmbH
Cocktail reception - Patio - outside
   
Conference dinner - Restaurant    

 
 Day 2  15th April 2015      

  Chairman's recap of day 1
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Roberto Castelnovo & Isabel Munoz - Founders
NL42
Simplifying Analytical Knowledge Transfer in an Externalized World
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Ryan Sasaki - Director of Global Strategy
ACD/Labs
Legal Aspects of Big Data Analytics
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Sofie van der Meulen - Attorney at Law
Axon Layers

  Workshop session 2A
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Workshop session 2B
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Workshop session 2C
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Workshop session 2D
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  Harmonization Tools for a successful Global Implementation of a Paperless QC Solution Building the Bridge between ELNs and Analytical Data Cloud + mobile: improve sampling activity, save time and become real-time Time for a change? Discovering alternatives to LIMS

  Workshop session 3A
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Workshop session 3B
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Workshop session 3C
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Workshop session 3D
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  Using Standardised Recipes
Not Only For Cakes!
The Data Odyssey:
E-Notebook and Spotfire the solution for Scientists
Connect your iPad to
OpenLAB ELN in the cloud
Managing process and data integration across ERP, LES, LIMS and analytical instruments

   Workshop session 4A
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 Workshop session 4B
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 Workshop session 4C
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 Workshop session 4D
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  Facilitating real time collaborative research in the mobile era  Advanced Paperless Compliance Meta-data transfer and SOP guidance – without overwhelming project time/costs? Automating Laboratory Processes & Achieving Secure & Compliant Data Management

Towards paperless in laboratory: Nugenesis experience
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Gorka Jiménez Bueno - QA Manager
IDIFARMA
What's next after being paperless?
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Corne Nous - Business Analyst
former Merck Sharp & Dome
Improving quality management by replacing  routine “paper based” laboratory “task” recording, using Aurora Vigilant software
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Stephen Pownall - Business Development Manager
Stratec
Exploring the FDA’s Approach Quality Assessment in OPQ
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Giuseppe Randazzo – Director Pharmaceutical Program and Regulatory Office
FDA
Wrap-end and closing Paperless Lab Academy congress P.J. Boogaard
Industrial Lab Automation