The PLA® Conference is planned for offering a balanced mix of keynote presentations, workshops, panel discussions and interactive sessions catered for different learning preferences and levels of expertise.

More specifically, the #PLA2023USA program included speakers from various industries and functions. Both industry experts and end users shared their practical experiences and case studies. This diversity provided a well-rounded perspective on the challenges and opportunities of digital transformation journeys in the laboratories.

In addition, the industry experts centred their presentations around the main theme of the event, “Master your eData Lifecycle” and each session had clear goals of how and where they wanted to steer the discussions.

Embrace an Ecosystem Mindset for Successful Digital Transformation

The ecosystem mindset refers to viewing digital transformation as an interconnected and collaborative effort involving various stakeholders, both within and outside the organization. It recognizes that no single technology or department can drive successful transformation in isolation.  Instead, organizations are encouraged to create a dynamic ecosystem of partners, technologies, and talent that work seamlessly together to achieve common goals.

Pat Pijanowski, John Conway and Lloyd Colegrove drew our attention to what lessons we could learn from the massively successful consumer-led digital transformation and what we could use to shift our own digital transformation strategy in the lab to be more driven by an ‘ecosystem mentality’

To successfully bring digital transformation to the lab, we all need to think a bit differently than we have in the past. We need to adopt an “ecosystem mindset” instead of an “application mindset”

Rely on Fundamental Quality Culture for Quality Production 

In the search for a definition of culture, every anthropologist has a slightly different view of what culture means. However, there are common elements in answering the question of what culture encompasses. Culture is the holistic combination of learned and shared beliefs, values and practises that create cohesion in a group.

The employees of a company thus form a group that works and acts in the way they believe is expected of their company, or better still, in the way expected of everyone role and responsibility.

Mark Newton, Chinmoy Roy and George Bernstein drew our attention to the importance of the human factor for a successful transformation of the digital lab.

They emphasise the responsibility of top management to foster a culture of quality in the organisation from top to bottom and to empower everyone through learning opportunities, mentoring, coaching and the promotion of transparency and ownership at all levels.

They also magnificently cover the delicate topic of balancing business needs with compliance gaps.  Highliging the relevance to consider compliance as a function that is judged on how it supports the business but also recommending business to understand how important quality requirements, and therefore compliance, are to the success of the business itself.

Master your Data Management for easier Innovation and Scaling 

In a data-driven world, companies that succeed in gaining actionable insights through data management will be able to innovate faster, develop better strategies and manage change more efficiently.

Many organisations today, especially global organisations, have hundreds of separate applications and systems where data that crosses departments or divisions can easily become fragmented, duplicated and usually obsolete. When this is the case, answering even the most basic but critical questions about any kind of performance metric or KPI becomes a problem for an organisation.

Fundamentally, the need for accurate, timely information is acute, and with the proliferation of data sources, it is an ongoing challenge to manage them consistently and keep data definitions up to date so that all parts of an organisation are using the same information.

Luke Guerrero and Patrick Courtney explained us that organizations have initiated the conversation about scaling their software usage and mastering data management. Luke talk summarized the current state and suggested pathways for organizations that think differently and want to learn from the successes in biotech and other industries. While Patrick dive into the role of standards and ontologies explaining how SiLA (Standardization in Lab Automation) and AnIML (Analytical Information Markup Language) could drive automation, data management, and machine learning.

Those are few glances to what happen at the PLA® Conference USA this last month. We look forward to welcoming at the next edition in the USA, Europe or India in 2024.

Access here the presentations 

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To meet this challenge, this PLA2023USA session will further explore the topic of mastering your data management with the fol

Transforming biomanufacturing: breaking through today’s digital technology tropes

How communication and data standards enable the automation and data management lifecycle

Presenting Patrick Courtney, Board of Director @SiLA Consortium

Laboratory automation and data management remain challenging tasks, in part because of the diversity of needs, processes and tools. Managing such diversity through modularity and standardization has been a successful approach and is being applied in the laboratory.

However, the role of standards and ontologies is often poorly explained. We will explain how SiLA (Standardization in Lab Automation) and AnIML (Analytical Information Markup Language) are driving automation, data management, and machine learning.

SiLA ensures seamless instrument control and workflow orchestration, while AnIML structures data for consistent analysis and collaboration. Through real-world cases we will present the impact of standards in shaping modern laboratory practices and fostering innovation. Finally, some recently advances in closed loop systems to accelerate research will be presented.

Master data management  is in fact the reincarnation of the problem of how to manage the consistency and integrity of the myriads of data assets that exist across the enterprise.

This session will be held at the Paperless Lab Academy® USA Chapter on Day 2, November 16th from 15:00 to 16:30.

Join the discussions at the Paperless Lab Academy® 2023 USA!

Get your free pass! REGISTER NOW *

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In this particular session we will go through real-word cases and discover from one hand the approaches of Boehringer Ingelheim and Catalent Pharma going global with their LIMS, where standardisation and  harmonisation are key factors for the success.

Leveraging cross-business synergies as pathway to digitalisation

The case of the MyLIMS program currently under way at Boehringer Ingelheim will be presented as a pragmatic approach to address the digitalisation of two apparently diverse businesses such as Animal Health and Biopharma with one holistic template-driven solution which brings significant benefits in terms of simplification of the application landscape, and is the foundation for ongoing and future integration with ERP, MES, LES , CDS and paperless mobile-based sample handling.

Managing Change in Multiple Laboratories: LIMS Deployments and the Benefits of Standardization

Presenting Geoffrey Trullinger , IT Global Lab Automation Software Operations Manager @ Catalent Pharma Solutions

Geoffrey is the Software Operations Manager for Catalent’s Global Laboratory Automation team and has a background in laboratory informatics, laboratory operations, and IT quality/validation.  He has experience implementing laboratory systems, ranging from specialized benchtop instrumentation to multi-site LIMS and chromatography systems, working with a variety of different laboratories and systems.  His approach focuses on the way that software can improve workflows, standardize processes, and reduce risk.

Effective change management is crucial when deploying a Laboratory Information Management System (LIMS) to multiple laboratories.  This presentation will explore key strategies and best practices for navigating the complex process of LIMS deployments, including determining lab readiness, identifying opportunities for standardization, and maximizing user adoption.  Join us as we delve into the essentials of change management to drive your successful LIMS deployment journey.

On the other hand, completing this session a special use case from Regenxbio where strategic integration is here key.

Advanced digitalization of QC-Micro Processes

Presenting Caitlin Harrison, Sr. Manager, QC Microbiology @ REGENXBIO, Inc.

Caitlin is an experienced Quality professional with over 12 years’ experience, specialized in Quality Control Microbiology in the pharma industry. Experience with implementation and validation of several different computer systems, focusing on development of MODA-EM for the QC lab and integration with processing equipment and external monitoring systems for automatic data migration.

Utilizing real-world examples, Caitlin Harrison will showcase the transformative impact achieve through strategic digital integration at a Cell & Gene Therapy organization. Attendees will gain a comprehensive understanding of the critical role of a robust digital strategy, elevated capabilities achieved through the innovative & proactive application of the MODA® platform. How digital transformation can enable companies to maintain a competitive edge.

This session will be held at the Paperless Lab Academy® USA Chapter on Day 1, November 15th from 14:00 to 15:30.

Join the discussions at the Paperless Lab Academy® 2023 USA!

Get your free pass! REGISTER NOW *

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One of the critical aspects of this transformation is the digitization of laboratory processes in the manufacturing industry. Laboratories play a pivotal role in ensuring product quality, innovation, and compliance.

Digitalizing laboratory processes is not without its challenges. Laboratories generate vast amounts of data that need to be managed, analysed, and stored securely. Moreover, laboratory operations involve complex workflows, stringent regulatory compliance, and interdisciplinary collaboration between scientists, engineers, and data analysts. Overcoming these challenges requires more than just implementing digital tools; it necessitates a holistic approach, which is where the ecosystem mindset comes into play.

The ecosystem mindset refers to viewing digital transformation as an interconnected and collaborative effort involving various stakeholders, both within and outside the organization. It recognizes that no single technology or department can drive successful transformation in isolation. Instead, organizations are encouraged ­­­­­­to create a dynamic ecosystem of partners, technologies, and talent that work seamlessly together to achieve common goals.

This article anticipates the discussions that will take place at the Paperless Lab Academy® USA on November 15-16 in Raleigh, NC. The opening session in particular, led by Pat Pijanowski, John Conway, and Lloyd Colegrove, will set the stage by challenging the current paradigm of application-centric approach.

They will introduce the concept of ecosystem mindset. The digital ecosystem has much more to offer today than it did when labs started adopting LIMS, LES, and ELN. The ecosystem mindset approach is too powerful to simply be overlooked.

Key Elements of the Ecosystem Mindset

• Collaboration: An ecosystem mindset encourages collaboration between different departments, functions, and even external partners. In the context of laboratory digitalization, this means breaking down silos between R&D, quality control, and IT to create a unified approach to data management and analysis.

• Openness to Innovation: An ecosystem mindset means being open to innovative solutions from multiple sources. Manufacturers should seek out technology partners, start-ups, and research institutions to tap into cutting-edge advancements in laboratory automation, data analytics, Machine Learning and AI.

• Scalability: Digital transformation in laboratories should be scalable and allow for the integration of new tools and technologies when needed. An ecosystem approach ensures flexibility to adapt to evolving requirements.

• Data Sharing: Laboratories generate valuable data that can benefit other parts of the organization. An ecosystem mindset approach encourage data sharing across departments to enable better decision-making and process optimization.

• Compliance and Security: Regulatory compliance and data security are paramount in laboratory operations. An ecosystem mindset includes robust governance mechanisms to ensure that all digital processes comply with regulatory requirements and reinforce data integrity.

Benefits of an Ecosystem Mindset in Laboratory Digitalization

• Accelerated Innovation: Collaboration within an ecosystem can lead to faster innovation cycles. Scientists can access external expertise and resources, leading to the development of breakthrough products and processes.

• Improved Quality Control: Real-time data sharing and analytics enable better control of the production. Manufacturers can identify and address quality issues early in the production process, reducing waste and improving product quality. With adequate ML and AI models, issues can even be anticipated and avoid.

• Enhanced Efficiency: Streamlined laboratory workflows and automated data analysis can significantly improve operational efficiency. This leads to cost reductions and a shorter time-to-market for new products.

• Better Regulatory Compliance: An ecosystem mindset approach ensures that regulatory compliance is built into digital processes from the outset, reducing the risk of costly regulatory issues.

• Futureproofing: The scalability and adaptability inherent in an ecosystem mindset make it easier for manufacturers to keep pace with technological advances and market trends.

The digital transformation of laboratory processes in the manufacturing industry is not a stand-alone endeavour. To succeed on this complex and data-intensive path, organizations must adopt an ecosystem mindset. By fostering collaboration, openness to innovation, scalability, data sharing, and a strong focus on compliance and security, manufacturers can realize the full potential of digitalization in their laboratories. The ecosystem mindset is not just a strategic choice; it’s the key to staying competitive and resilient in the rapidly evolving landscape of modern manufacturing.

Opening session: Adopt an ecosystem mindset for successful digital transformation + panel discussion

The Ecosystem for Digital Transformation is All Around Us!

Pat Pijanowski, former Managing Director at Accenture Scientific Informatics Services

The Cloud, Edge Computing, 5G Networks, Low-Code/No-Code BPM solutions, Artificial Intelligence & Machine Learning, Augmented and Extended Reality, Broadband communications around the world….  The ecosystem for digital transformation is all around us!  One only needs to look at the many ways in which our everyday lives have been transformed over the past couple decades to see the promise of the tools available to us in today’s world.  And yet, so many organizations have struggled to leverage these same digital enablers within the laboratory environment.  Why is that?  And what must we do?

Successfully bringing Digital Transformation to the Lab requires us all to think about things a bit differently than we have in the past.  Successful Digital Transformation requires us to adopt an “Ecosystem Mindset” instead of an “Application Mindset.” And the good news is……. It’s Happening!!!

There is No Such Thing as “Just” a Digital Transformation

John F. Conway, Chef Visioneer Officer at 20/15 Visioneers

Culture Change enables strategy adoption and the ability to adopt new strategies such as a Scientific Data/Process and Decision Strategy and make them actionable. What also transforms is the science and technology as well as all their processes and very importantly the “unknown” art of the possible! This talk will highlight current use cases and lessons learned.

Fundamental Problem Solving, a simple but transformative discipline

Lloyd Colegrove, former Director of Data Service at Dow Chemicals

Digital transformation and culture change go hand-in-hand and are critical to taking advantage of what new digital technologies have to offer, but in your operational environment have you ever considered how your newly transformed and digitally enabled workforce will successfully perform to solve operational problems and improve operational performance?

“Fundamental Problem Solving” is a discipline formalized around the old elementary school science fair concept of hypothesis and testing, combined with the complexities of “adult” technological issues around problem identification and solving.

Three questions, which your elementary school science teacher did NOT teach you, form the basis for powerful industrial problem solving of operational issues that mysteriously recur even after you think you have put them to rest, or identifying and mitigating so-called “multi-effect” problems – problems that do not have one clear or obvious root cause. Serendipitously, the precepts of fundamental problem solving can be applied to all aspects of life including but not limited to – career development, family vacation debates, and even where you and your partner may go for dinner tonight!

Join the discussions at the Paperless Lab Academy® 2023 USA!

Get your free pass! REGISTER NOW *

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The “Data-driven” here implies much more than just technology and data.  it requires a special mentality,  a leadership attitudes, that makes it possible to take informed decisions by systematically using data to improve business performance.

To lead the data-driven culture, corporations need to first establish a stream of clean, accurate, reliable, and active data feeds reflecting all major business activities. All these qualities are critical for employees to trust the data, the technology, and the tools – any limitation can prove to be the single point of failure in making the data-driven vision happen.

The success of machine learning (ML) and artificial intelligence (AI) applications requires large quantities of training and test data. This need creates critical challenges not only concerning the availability of such data, but also regarding its quality.  ML and AI are highly dependent on the quality of data used to train models. Incomplete, erroneous, Poor data quality can lead to can lead to inaccurate predictions, unreliable model performance and ultimately poor decisions.

This why this session will be focused on the Data quality which is of critical importance especially in the era of Artificial Intelligence and automated decisions. Share real success stories on how the use of data allowed smart decisions with real financial gains for the company

There are many aspects to data quality, including consistency, integrity, accuracy, and completeness. According to Wikipedia, data is generally considered high quality if it is “fit for its intended uses in operations, decision making and planning, and data is deemed of high quality if it correctly represents the real-world construct to which it refers.”

Debabrata Sanyal, Senior General Manager – Corporate Quality Assurance and Digital Automation – MSN Laboratories Private Limited

Debabrata Sanyal is Senior General Manager in Corporate Quality Assurance and Digital Automation in MSN Laboratories Private Limited. He brings 22 years of experience in diversified field of Quality Management predominantly in Quality Assurance, Quality Compliance and Regulatory Affairs. Debabrata previously worked for Regulatory Affairs and Quality System in renowned organisations like Cadila Pharmaceuticals, Torrent research Center, Aurobindo Research Center and MSN Laboratories Private Limited. In his recent assignment at MSN Laboratories Private Limited, Debabrata works for transforming the long-term digitalisation and automation targets into process and solutions.

Use Cases of drug discovery automation and ML models

Samiron Phukan, Senior director Computational (AI/ML) Modelling & Digital Transformation integrated Drug Discovery and Development at Aragen LifeSciences

Samiron Phukan has nearly 20 years of experience in the field of informatics driven solution in drug discovery and development. He had worked in various pharmaceutical companies and CROs in India in the field of drug discovery and development from concept to clinic in various therapeutic areas like oncology, metabolic disorders and anti-infectives using computational modelling and informatics. He had set up the state-of-the-art informatics laboratories in various pharmaceutical companies like Jubilant Biosys, Dr. Reddys’s Laboratories, Lupin ltd. Presently he is heading the CADD/informatics division in Aragen Lifesciences Hyderabad. In addition to his current role of heading the scientific team of computer aided drug design scientist, he is involved digitization, automation and development of various proprietary platform technology using ML tools to aid drug discovery and development.

How communication and data standards enable the automation and data management lifecycle

Burkhard Schaefer, AnIML Task Group Lead, SiLA Consortium

Communication and data standards form the bedrock of efficient laboratory processes. This presentation explores the role of SiLA (Standardization in Lab Automation) and AnIML (Analytical Information Markup Language) in driving automation, data management, and machine learning. SiLA ensures seamless instrument control and workflow orchestration, while AnIML structures data for consistent analysis and collaboration. Learn how the synergy between these standards fuels closed-loop experimentation, enabling optimized parameter adjustments using real-time insights. Through real-world cases, this presentation discusses the impact of standards in shaping modern laboratory practices, fostering innovation, and accelerating research.

Followed by Panel Discussion: How to set standards for the Lab 4.0

DISCOVER FULL PROGRAM HERE

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The goal is to discuss how to get the most out of digitized labs so that all information provides valuable insights and accelerates innovation.

The #PLA2023India program therefore plans to take you through several reflection phases covering key topics to consider as you move towards the digital transformation of your labs and quality processes.

It is certainly necessary to clarify in advance what the concepts of digitization, digitalization and, above all, digital transformation mean.

Digitization would be what we used to call paper on glass a few years ago. Basically, it’s about translating analog information into a digital format and then storing it for better accessibility.

Digitalization entails changing business processes by using new software platforms to work faster.

Digital transformation goes beyond digitalization efforts and involves the entire organization. For most companies, it means moving away from traditional thinking and toward a synergistic approach where technologies are deployed across the enterprise to drive fundamental change.

The key benefits are increased efficiency, greater business agility and ultimately unlocking new value for employees, customers, and shareholders.

These new ways of working bring to light innovative solutions that, in turn, can improve the customer experience, drive employee innovation, and drive business growth at a fundamental level.

There are many different paths to digital transformation and each company’s journey is unique.

In this opening session, led by Raj Kumar Patra, Group Product Head – Quality & EHS/Supply at Reckitt and Dinu Abraham, Head Tech Apps Pharma R&D and Quality at Lupin, they aim to share their own experiences and insights with the audience.

Unlocking Data: the new gold mine

presenting: Raj Kumar Patra, Group Product Head – Quality & EHS/Supply at Reckitt

In today’s digital age primarily driven through technological innovations, data plays a key role to any organization’s success story. Whether it’s crucial business insights or trend analysis or investigative deep dive, data plays a crucial role in our life sciences and CPG industries.

Labs and R&D communities can benefit hugely from data led innovations and transformations if done correctly and scaled appropriately. Key is building the right foundations to then unlock multiple value streams powered through data pipelines and linked visualization solutions.

IT transformation and digitization programs in regulated environment

presenting: Dinu Abraham, Head Tech Apps Pharma R&D and Quality at Lupin

Collaborative innovation and operational excellence are possible through digital continuity. It requires organizations to transform from paper-based processes to data-driven approaches, from process execution to real-time business impact analysis, and from transactional to more standardized regulatory dossiers.

Companies that are data-driven tend to get where they want to go faster and more efficiently. As it becomes easier and easier to collect and store data today, data analytics is gaining momentum as the best technique for business decision making. Data and information are the basis of all actions, as such data collection and analysis are the main drivers. By using data from the past and present, a data-driven approach can help predict the future.

But again, we should not forget that the human factor plays an important role, as experience and background knowledge are crucial for final decision making.

On the other hand, many decision makers rely on their experience and instinct and base their decisions on a few numbers. However, how these numbers are interpreted remains subjective.

How to base decision making on hard facts, AKA data, and avoid the risk of making wrong assumptions and being guided by bias is the essence of the data-driven approach. not only for an appropriate approach to your digital transformation project, but also for sound business decision making.

Let´s hear more from our keynote speakers and panellists at #PLA2023India

Do not miss the opening session that will set the stage for the many discussions that will take place during these 2 fruitful days.

Raj Kumar Patra, Group Product Head – Quality & EHS/Supply at Reckitt

Raj comes with close to 2 decades of industry& technology experience across Lifesciences and CPG industries spanning R&D and Labs. He has led several large and complex business digital transformations spanning Cloud, Data and SaaS adoption. Currently he leads the product groups across Quality and Supply at Reckitt and is helping drive multiple value-based initiatives.

Dinu Abraham, Head Tech Apps Pharma R&D and Quality at Lupin

Dinu offers over nearly 20 years of thought leadership expertise in effectively partnering with the business, stakeholders, and product development team to manage large-scale Global IT Transformation / Digitization Programs in Highly Regulated Environments– Implementation of GxP Applications, IT Business Applications (cGMP / GxP Software, SOX & other commercials applications) Portfolio Management, CSV Lifecycle / Program Quality Management, Business Process Re-engineering, QC Lab & Mfg. Shop floor Automation, Setting up of CoE, Product Development/Enhancement. Dinu has also successfully led some of the Strategic GxP Automation & IT Programs

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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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We are glad to propose a dedicated session to that important topic, our keynote speakers Ms Madhurima Putcha, IT&D Product Manager at Reckitt and Mr. Saravanan Ilangovan, Corporate Registrar at Elanco will share their experiences about their own project, two very interesting data migration projects and strategies.

In this session, data migration will be addressed from two different angles. On the one hand, a data migration project with the main goal of standardization and harmonization within an on-premises infrastructure approach, and on the other hand, a data migration project to the cloud with strong focus on GXP requirements.

Transform your R&D with Digital Innovation and Legacy Wisdom

Presenting: Saravanan Ilangovan, Associate Director in ELANCO’s Clinical Operations.

Elanco has been part of Eli Lilly’s animal health business for more than 50 years. When Elanco separated from Eli Lilly, the two companies also had to separate their businesses and data in a very short period of time. Despite these special business circumstances, Mr. Ilangovan will present a typical situation where the main goal is harmonization and standardization. This is a remarkable challenge, considering that structured and unstructured data have different formats and that legacy systems usually work in silos to begin with. Saravanan will share with us his company’s strategy to implement a “one-system” approach” while employees work without interruptions.

Path to the Cloud for GXP Systems

Presenting: Ms Madhurima Putcha, IT&D Product Manager at Reckitt

With so much of cloud transformations happening everywhere, Life science industry is also taking steps towards the cloud transformations. While for technology-oriented systems have better approach towards cloud, it is always a complex path when we try to move a GXP/regulatory and highly human sensitive data into cloud. I will be talking about my experience in migrating some of LIMS and Clinical related system into IaaS and SaaS clouds and how easy or difficult it was for us to achieve this transformation without disrupting the business process.

Why a comprehensive data migration strategy prevents major issues

Whether data is migrating from inputs to a data lake, from one repository to another, from a data warehouse to a data mart, or to or via the cloud. Without a competent data migration plan, organizations may go over budget, face overwhelming data processes, or find that their data operations fall short of expectations. Less successful migrations can result in inaccurate data that contains redundancies and unknowns. This can happen even when the source data is fully usable and appropriate. In addition, problems that were already present in the source data can be amplified when transferred to a new, more complex system

The presentations will be followed by a panel discussion with the two experts, Ms. Putcha and Mr. Ilangovan, and Ms. Muñoz-Willery as moderator, in which the audience can actively participate to learn more about how to take the right steps for your project.

In preparation for this session, here some food for thoughts

Critical factors to be considered for a successful data migration

• Know your data: Before migration, source data needs to undergo a complete audit. Unexpected issues can surface if this step is ignored.
• Cleanup: Once issues are identified they need to be resolved. This may require additional software tools and third-party resources because of the scale of the work.
• Maintenance and protection: Data undergoes degradation after a period of time, making it unreliable. In order to maintain the data quality it is requires to put down some controls in place
• Governance: Tracking and reporting on data quality is important because it enables a better understanding of data integrity. The processes and tools used to produce this information should be highly usable and automate functions where possible.

In addition to a structured, step-by-step procedure, a data migration plan should include a process for bringing on the right software and tools for the project. At the Paperless Lab Academy® you should expect good overview of the industry offering by visiting the exhibition hall and attending their interactive workshop at #PLA2023India

Ms Madhurima Putcha, IT&D Product Manager at Reckitt

Ms Madhurima Putcha has 12 years of experience handling LIMS transformation programs, both on-pre migrations and cloud transformations. She got extensive experience in connected Labs specifically in QC and supply areas and recently working for R&D area as well.

Madhurima has a Masters in computer science. She is a very passionate women trying to build competent Lab and R&D tools and products for her business and always believe a product should go hand in hand with process.

Saravanan Ilangovan, Associate Director in ELANCO’s Clinical Operations.

He has 19 years of experience in pharmaceutical digitalization. He is a seasoned professional who has been at the forefront of driving digital innovation and transformation within the industry. Saravanan’s journey in pharmaceutical digitalization began with a strong foundation in technology and a deep understanding of the unique challenges and opportunities within the pharmaceutical landscape. Over the years, he has successfully led and implemented a wide range of large-scale digital initiatives across the pharmaceutical industry in India and EMEA, which includes Scientific Data Mining, Electronic Laboratory Notebook (GXP / cGMP), Compound Management, Inventory Management, Instrument Management, SDMS, and Legacy Data Migration with the adoption to latest technologies trending in the industries.

Saravanan’s expertise extends to areas such as process mining, supply chain digitalization, and regulatory compliance. He collaborated closely with cross-functional teams, stakeholders, and industry partners in planning and ensured the successful implementation of digital strategies that meet regulatory requirements and deliver tangible results.

As an industry leader in pharmaceutical digitalization, I am driven by the belief that technology can be a powerful catalyst for positive change in healthcare. I am dedicated to shaping the future of the pharmaceutical industry, creating a patient-centric ecosystem that embraces digital transformation and harnesses the full potential of technology to improve lives and make a lasting impact.

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In fact, when it comes to digitising R&D and QC lab processes that operate in regulated environments, discussions start (or better, should start) with how to properly manage the data generated in the labs. On the list of requirements set by the project stakeholders, compliance with industry regulations is certainly one of them and the measures to be taken are an essential part of the project plan.
Precisely because it is so important, discussions on quality are addressed in a special session at the #PLA2023USA consisting of presentations delivered by internationally recognised experts and followed by a panel discussion to further deepen the conversation with participants.

Defining the Quality Culture

We will talk about risk management, computer software validation and data integrity, but… this will not be a training session on concepts or an endless list of guidelines… this session will mainly deal with the concept of quality culture within an organisation and how to ensure appropriate behaviour of all components of the group.

In the search for a definition of culture, every anthropologist has a slightly different view of what culture means. However, there are common elements in answering the question of what culture encompasses. Culture is the holistic combination of learned and shared beliefs, values and practises that create cohesion in a group.

The employees of a company thus form a group that works and acts in the way they believe is expected of their company, or better still, in the way expected of everyone role and responsibility.

For this very special session, we are honoured to have as guests three internationally renowned experts who will share their experiences and use cases and lead us to a concluding Panel Discussion on challenging the paradigm of getting things done just for the sake of the next audit. Provocative but healthy and certainly respectful discussions.

Discussing Quality with our international keynote speakers

Mark Newton, owner at Heartland QA, will address the delicate topic of balancing business needs with compliance gaps. It is important that compliance remains a function that is judged on how it supports the business. However, it is important that the business understands how important quality requirements, and therefore compliance, are to the success of the business itself. Mark will take us in his presentation from his 30+ years at Eli Lilly as an Associate Quality Assurance Senior Consultant and his great contribution as co-editor of several GAMP guides.

Chinmoy Roy, CSV and Data Integrity SME, Independent Consultant, will develop further about the approach to data integrity risk management using data integrity maturity model and process mapping. He will also bring a case study about conducting DI risk assessment in a QC laboratory.
Chinmoy is a biopharmaceutical consultant with over 40 years of experience in CSV, Data Integrity, 21 CFR Part 11, Annex 11 and manufacturing process automation. His presentations blend his field experience to highlight the intricacies of implementing regulations

George Bernstein, Ph.D., President of MAI Consulting, will then focus largely on the human factor in the compliance execution: the Data integrity wild card. George has a Ph.D. in Chemical Engineering and over 30 years of experience in pharmaceutical manufacturing, laboratory operations, data integrity, effective training, and quality risk management. In his presentation, George will touch upon the opportunities and human factors that lead to data integrity breeches, and strategies to further mitigate that risk.

“We have engineering and software solutions to reduce opportunities for data integrity breech, but these are applicable for some but not all areas of exposure. Use of legacy equipment, logbooks, and manual entry into batch records requires training and QA oversight to minimize data integrity risk. Unfortunately, training is often ineffective, and QA staffing may be in short supply.” commented George during our interview.

Following these 3 master presentations, the panel discussion will be used to discuss the next steps for your projects.

Invitation to #PLA2023USA

Mark, Chinmoy and George are far more than senior advisors who can identify problems and potential root cause when they visit a customer site. They are independent voices with a strong desire to close the gaps identified with their clients.

Open and honest, they will tell you their truth. Whether you like it or not, no one is left untouched by what they have to say, based on their vast experience in the field and their vision from international exposure.

Whether your laboratory operates in a highly regulated environment such as the pharmaceutical, but also the forensic or the cannabis industry, whether your laboratory is dedicated to research and development or quality control… Quality is not only a matter of compliance, but also a matter of business success.

Join the discussions at the Paperless Lab Academy® 2023 USA!

Get your free pass! REGISTER NOW *

Mark Newton has been employed for 33+ years by Eli Lilly and Company in several cross-functional roles.  Starting as a Microbiologist, he spent 14 years within the chemical, pharmacological, and microbiological areas of QC Laboratories as an analyst, method developer and supervisor.  The balance of his career has been within IT and Quality, implementing GMP software, serving as computer system QA, then a Laboratory Data QA representative, developing standards for qualification of laboratory computerized systems and training lab personnel in data integrity auditing, gap identification and remediation techniques.
He is co-editor of the GAMP Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (2nd ed), and currently co-leader of the GAMP Data Integrity Special Interest Group (SIG) and the ISPE Global Documents Committee.  He has recent publications in Pharmaceutical Engineering, Scientific Computing and the ISPE Blog (ISPEAK).

Chinmoy Roy, CSV and Data Integrity SME, Independent Consultant. Chinmoy Roy is a biopharmaceutical consultant with over 40 years of experience in CSV, Data Integrity, 21 CFR Part 11, Annex 11and manufacturing process automation. He was one of the architects for designing and implementing the largest paperless biologics manufacturing plant in the world. He was a member of ISPE’s Data Integrity Special Interest Group (S.I.G). He travels the world to train industry personnel in the areas of his subject matter expertise of CSV and Data Integrity as well as to conduct data integrity audits…
Chinmoy has a bachelor’s degree in electrical engineering and a master’s degree in computer science.

George Bernstein, Ph.D., is President of MAI Consulting. He has a Ph.D. in Chemical Engineering and over 30 years of experience in pharmaceutical manufacturing, laboratory operations, data integrity, effective training, and quality risk management. Since 1988, Dr. Bernstein has consulted both nationally and internationally with major pharmaceutical companies to address compliance actions by Health Authorities. He has lectured internationally on quality systems and root cause analysis to industry trade groups, quality organizations, and at PDA and Interphex conferences. Dr. Bernstein’s experience, insights, and innovative problem solving have been integral to his work which ranges from training effectiveness, GMP compliance, facility design, construction, and commissioning to business process re-engineering and process optimization. He has developed global quality standards (GLP, GCP, GPP) for a major international pharmaceutical company, and has assisted many clients with audit preparation, remediation activities, and communications with the US FDA.

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The PLA has recently celebrated its 10^th European edition. In 2023, PLA  will celebrate it 4^th Indian edition in October 10 & 11 at the Marriott Westin Hyderabad Mindspace..

The two-day conference, organised by NL42 Consulting, brings together participants, industry though leaders, and solution providers in an environment designed to encourage mutual interaction and exchange of views during plenary sessions and theme-based interactive workshops.

NL42 Consulting is glad to announce its partnership with GarudaVARS for its second in-person edition in India.

Isabel Muñoz-Willery, owner of Paperless Lab Academy® and event director, said:

“ With the collaboration of GarudaVARS, we believe that the PLA’s successful formula will become a reference in the APAC region, sitting in India. GarudaVARS brings a team with strong experience on event management within the laboratory informatics arena. We believe this is the beginning of a promising journey for the PLA in the APAC region.”

 

Sruthi Shyamala, Director of Customer Relations & Partnerships comments:

“GarudaVARS collaborates with Paperless Lab Academy® for the Indian edition, which presents an opportunity to support the goal of connecting knowledge, skills, and business under one roof to simplify lab informatics and accelerate lab digital transformation.”

About the Paperless Lab Academy®

 The PLA conferences are held annually in Europe, India and US.

The PLA is aimed at directors and managers of research and development, IT, and quality departments in the pharmaceutical, cosmetics, biotechnology, consumer goods, food and beverage, petrochemical and chemical sectors.

The conference aims to provide the ideal learning platform for all organisations involved in running laboratories to discuss about the consolidation, integration, and management of the digital data they generate.

Registrations are available at https://www.paperlesslabacademy.com/india/

About NL42 Consulting

NL42 Consulting is the owner and organiser of the Paperless Lab Academy®.

It is also a dynamic, free-thinking, independent management consultancy. Combining the flexibility and enthusiasm of a team with decades of experience in laboratories digital transformation. The expertise the company offers is a powerful combination of technical know-how, in-depth management knowledge of laboratory workflows and international networking.

Contact: Isabel Muñoz-Willery Ph.D.  

About GarudaVars

At Garuda VARS, we are passionate about collaborating with businesses and assisting them in their business growth. With in-depth expertise and significant experience in Problem Solving, Business Analytics, Creative Services, Event Management, and Business Development, we offer our clients a variety of services tailored to suit their individual requirements and enhance their business acumen.

Contact: Sruthi Shyamala  

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