We are glad to propose a dedicated session to that important topic, our keynote speakers, two thought leaders in the industry will address the situation and give the industry food for thought for their digitization projects. Mr. Kamlesh Padiya, Director at SynVision Chem Pvt. Ltd and Mr. Chandra Sai Dusanapudi, Assistant General Manager at Aurobindo Pharma Ltd.

“The advantages of an electronic database system over a paper-based system are well known and accepted,” explains in our interview Mr. Kamlesh Padiya.

As such in this particular session, we will take this as a given and focus on why it is still so difficult to successfully implement those lab informatics systems.

Human factor is key for successful implementation

Presenting Mr. Kamlesh Padiya, Director at SynVision Chem Pvt. Ltd

With nearly 20 years of experience implementing ELN and LIMS, Kamlesh will share his matured reflexions and conclusions about what prevents companies from getting the most out of these implementations. Everyone uses barcode reading in every store these days to capture and pay for merchandise. So what’s holding analysts, back at work, from realizing the full potential of an ELN ?

Change management, the mindset challenge, the cultural shift, the user interface … or the need to properly involve all business experts in defining the new digital processes and configuring the systems?

A deep analysis that Kamlesh will share with PLA2023India attendees to make them think and bring it to your teams.

Approach “3A-3C” for better digital-GxP 4.0

Presenting: Chandra Sai Dusanapudi, Assistant General Manager at Aurobindo Pharma Ltd.

Chandra has recently published the 3A-3C approach to digital solutions in the pharmaceutical and healthcare sector and will further develop the 3A3C concept during his presentation.

Chandra proposes a better approach to overcome the current challenges in the digitization of the Pharma sector

3C, the challenges:

• • • • Compliance
      • Cost-effective solution
      • Comfy to use by end users

3A, the key steps to achieve the 3C:

• • • • Analyze the requirements
      • Assess the best fit to purpose solution and vendor
      • Adopt the solution at its best

A recent survey conducted by Mr. Dusanapudi found that 75% of participating Indian companies are still in the process of implementing LIMS applications, but not only, but also QMS and DMS.

The largest companies implemented solutions 10 or even 20 years ago. They have acquired extensive knowledge about digital data management, process digitization, automation, system connectivity, data lakes and more……Nevertheless, they are in a very single position of dedicated teams for digital transformation and operational excellence.

Thousands of companies are still struggling with the very first steps of their digital journey. Some are simply forced to think about it because auditors are becoming more demanding when they do not see digital processes. Others because the pandemic period has awakened the reluctant CFO and empowered the CIO, still others because they see the need to remain competitive, efficient, productive and compliant in a fully digitized ecosystem, and so on and so forth

In India and the rest of the world, there is still a high percentage of companies that are still struggling to find the right solutions, even though they have been in the market for almost 40 years. So let´s stop thinking that this is because of the solution and start putting the right pieces of the puzzle together for a successful implementation project.

Chandra Sai Dusanapudi, Assistant General Manager at AurobindoPharma Ltd

Currently working as AGM in AurobindoPharma Ltd. Having 17 years of experience inthe GxP domain. worked in Digitalization, CSV,IT Compliance, Analytical R&D and Quality control. He also has Published different articles on Data integrity,CSV, GxP cloud and other topics.

Kamlesh Padiya, Director at SynVision Chem Pvt. Ltd.

A seasoned Chemistry professional with 20 years of experience in the entire drug discovery cycle, from target scouting to Process Development and cGMP manufacturing of drug substances. I have managed all aspects of the Research and Development R&D project from planning and budgeting to scale-up and production support. Proven record in leading, managing, and delivering projects in a global environment. An accomplished leader in the development of a sustainable process for the manufacture of KSM and API, and the digital transformation of drug discovery and process research laboratories.

Successfully, configured and implemented several digitization projects at various organizations:

1. E-Labnote book: Piramal Research Centre and Lupin Limited.
2. LIMS: Piramal Research Centre
3. CIMS (Chemical Inventory Management System); Nycomed Pharma
4. KRISCH (Compound Registration System): Nycomed Pharma
5. Spotfire (Data analytical tool): Lupin Limited.

In-house system developed and implemented

1. LInfoViz (Lupin Information Visualization): Lupin Limited
2. LuCIN (Lupin Chemical Inventory System): Lupin Limited
3. LuCAS (Lupin Compound Archiving System): Lupin Limited

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The Paperless Lab Academy^® works in providing the audience food for thoughts in their digital transformation journey and in coordinating access to the latest technology offering of the lab informatics industry.

Fact is that when looking at laboratory and quality processes to be digitalised, several layers need consideration and multiple questions need answers. It is not always easy to even understand where to start and how to formulate decisions. A strong recommendation is to start with mastering your own data life cycle, and as such verify that the required regulatory compliance are observed in each steps and phases: eConnect, eManage, EDecide & eArchive.

Master you  Data Life Cycle

That is why we’ve collected a series of presentations developing further more from Raw Data capture moment to efficient use of the data for analytics, business and artificial intelligence.

Whether they are raw data from chromatographs or any other analytical instruments, they have been at the heart of many data falsification and poor data management practices found in many FDA warning letters since the Able Laboratories fraud case in 2005.

Breaches to data integrity can be avoided by creating flawless data transfer from instruments to systems, including avoiding use of spreadsheets for calculations. If you’re open of being challenged We Mr. Bob McDowall, we warmly recommend you to attend his provocative yet funny and to the point presentation: Are Spreadsheets a Fast Track to Regulatory Non-Compliance?

Consider an electronic process with validated calculations and electronic signatures 

The message will be reinforced by Mr. Mark Newton´s presentation on Data Forensics with a  pragmatic example and exercise about the importance of metadata. The information about the data that brings a deeper understanding about the quality of the final results. 

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” and Co-editor of the GAMP Good Practice Guide “A Risk-Based Approach to Compliant Computerized Laboratory Systems”.

Systems Integration approaches 

Yet more instruments are involved in a analytical processes and additional metadata and unstructured data are to be facilitated alongside the raw data. Andreas Steinle from Roche Diagnostic will take us through their very specific Instrument integration strategy and journey and explain how to unlock your analytical instrument data for data science 

Mr. Vipul Krishan Yamdagni, now independent GMP consultant and advisor, brings 34 years experience in the industry with major Indian Pharma organisations about digital strategy and systems integration. Vipul will share his view on  Digital Pharma Laboratory – challenge | opportunity | way forward 

Implementation experiences by time of COVID

Despite the pandemic situation and the lockdown, manufacturing companies had to react quickly to the situation, remain productive while implementing safety procedures for their employees.  Three presenters will explain us how they’ve overcome the situation, implemented solutions and taken benefit of them during this though and challenging moment.

Ms. Preeti Gaonkar, SEAP Quality Excellence Manager at SGS India Private Limited will explain how they have accelerated  their quality with digital transformation. By implementing of a Quality Management System digital system they could incorporate efficient electronic workflows to manage their quality events, audits, SOPs, quality documents and employee training records.

Mr. Albert Almajano, Chief Information Officer at Indukern Group will share their company strategy and experience in remaining focused to the implementations during the lockout situation with his presentation, Albert will show us a Roadmap to Digitalisation with Success

Mr. Sergio Nasi, Head of IT Operations Laboratory Execution at Boehringer-Ingelheim  will provide and overview of an ongoing implementation of a laboratory execution system and explain how additional challenges and opportunities the global COVID-19 pandemic have meant to the project implementation. Sergio will help us to Define your own pathway to the paperless QC laboratory: lessons learned from an ongoing project

Data Analytics and Artificial Intelligence

Toni Manzano, Chief Science Officer, R&D Director and Co-founder at Bigfinite brings a strong experience on data analytics, machine learning, artificial intelligence and sound knowledge on all related algorithms and statistics concepts behind. A unique opportunity to listen to an AI specialist with strong domain knowledge of the manufacturing industries.

Do not miss  the opportunity to benefit from his presentation and learn about Data Centricity: What is behind the AI implementation in Pharma

Dr. Lloyd F. Colegrove, Director at  Dow Chemicals, now retired and consultant, has 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´s talk “Digital Transformation in the Chemical Industry. The Devil’s in the Details” will feature artificial intelligence as an example of a key future value delivery mechanism in digital transformation. The road to installing AI in the Chemical Industry is fraught with challenges and many dead ends.

Those are the topics and presenters  that you should expect to listen to and discuss about during the Paperless Lab Academy 2020 India online event.

Make sure to Register  for you to access the virtual event platform !

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Once again, our Premium Media Partners, Scientific Computing World and Editrice Industrial and their 2 dedicated portals Labworld.it and Industrychemistry.com are facilitating an exhaustive presentation of the Paperless Lab Academy 2018 Sponsors in English and in Italian respectively. Our sponsors are making possible to maintain the free access to attendees.  Solutions and services providers of the Lab informatics market are given the opportunity to introduce themselves and present their latest offering.

The event has become one of the best showcase where to meet and discuss the future coming technologies to the lab, clarifying basic concepts like web-based and SAAS, metadata and master data, electronic signature and CFR21/11, data archival and data backups but also discover what´s boiling these days, as  the digital twin, the General Data Protection Regulation ( GDPR) May´s deadline, blockchain, Internet of Lab things….

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Above all, the event has the ability to attract well known international leaders in the market and an impressive long list of new comers. They might come from US or India yet new to the European market, they might come from Europe, young company with fresh ideas and innovative alternatives. They might also be very dedicated to a concrete area of the R&D laboratory for new molecule design. They might propose a solid solution for microbiology quality control or a dedicated tool for managing unstructured data or in the contrary propose a full portfolio of assets covering the complete data life cycle.

See all sponsors interactive workshop proposal for the PLA2018 – here

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Video: TV3 a la carta / generación digital / ens-endinsem-en-el-fenomen-paperless-viure-sense-papers

The program starts with the Paperless book written by David Sparks that was selected as one of the “Best of 2012” by the iBooks Store.

Paperless takes the mystery (and fear) out of going paperless with your Apple technology. The book includes 32 screencasts, 4 movies, over 26,000 words, and other rich-media assets to turn you into a paperless ninja. The material is accessible to beginners and power users alike with a thorough explanation of all the hardware, software, and workflows necessary to finally conquer paper.

The TV3 camera went through the paperless lab academy congress and discovered what is the industry investing in. Isabel Muñoz took them to the laboratory data management concept with practical daily life example  like all the metadata associated to a single smartphone picture. As for all interviews, in the end we´ve got our  1 minute fame!

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