Global Head of Quality IT at Wockhardt Limited

Deepa Pangaonkar is a results-driven professional with over 25 years of experience in implementing computerized systems across various domains, including laboratory systems (QC). She is the Global Head of Quality IT at Wockhardt Limited at the moment. Her areas of expertise are GAMP 5, 21 CFR Part 11, Annex 11, and other regulatory requirements related to computer system validation. Her areas of expertise also include digitalization and automation projects, creating compliance- and data-focused quality systems, and encouraging an internal CSV (Computer System Validation) culture in businesses.

Founder & CEO of Archimedis

Duraisamy Rajan Palani is the Founder & CEO of Archimedis Digital and a technology entrepreneur with over 25 years of experience in life sciences, software engineering, quality systems, product management, and digital transformation. His career spans leadership roles at Cognizant, Johnson & Johnson, and executive product management, where he has led quality engineering, GxP compliance, product strategy, and go-to-market initiatives for global pharmaceutical organizations. With deep expertise in AI, validation, and connected manufacturing, Durai is leading Archimedis Digital’s mission to transform regulated industries through intelligent, AI-powered solutions. A serial entrepreneur with two successful exits, he is currently building his third venture, focused on accelerating digital transformation, compliance, and operational excellence across the global life sciences ecosystem.

 

America’s Steering Committee Member

FDA Industry CSA Team And GAMP

Ken Shitamoto is a technology and quality leader with more than 30 years of experience in the pharmaceutical industry, including roles at Genentech, United Biosource Corporation, and Gilead. His work focuses on modernizing quality and validation practices for regulated computerized systems, emphasizing risk-based approaches and software quality engineering.

Ken actively contributes to the global industry through organizations such as the FDA Industry CSA (FICSA) team and the GAMP Americas Steering Committee. As a member of FICSA and co-lead of GAMP’s Computer Software Assurance Special Interest Group, he is helping advance the practical implementation of modern assurance and validation practices. He has also contributed to industry guidance publications including GAMP 5 Second Edition, Enabling Innovation, and Data Integrity by Design.

 

VP & Global IT Head
Actylis

Dr.Mukund KS (DLitt) is a Distinguished Global CIO Certified (ISB) Technology and Business Visionary, with Executive Hands-On experience in Heading End-To-End IT, Digital Transformation, Infrastructure, Governance & Security, ERP & CRM Programs.

Endowed with Rich & Diversified Industry Experience spanning over 20+ years, across various Industries, Domains and Geographies. A Strategist proficient at fragmenting Corporate Objectives into actionable technical programs, solutions and systems through Innovative means of Simplification, Automation, Design Thinking and Digital Transformations to maximize revenues and profits.

A fiscally conscious Technology Evangelist focused on Rapid-ROI backed Initiatives / Programs with Documented and Quantified Business Benefits.

Visionary thinker with entrepreneurial attitude, an inspirational leader and outstanding team player, creates robust strategies through a collaborative approach translating vision into achievement.
People’s leader, responsible for Motivating Global Teams for top achievements and retaining High value Diversified IT Talent Globally.

A Charismatic Communicator and Speaker easily interfaces with C-Level Executives and across various lines. A winner of multiple awards and recognitions for Global Deployments. Mentor for start-ups and students.

 

Vice President and CIO

Reliance Life Sciences Pvt. Ltd.

Pranav Gadre is the Vice President and CIO at Reliance Life Sciences Pvt. Ltd., where he leads the organization’s digital transformation, enterprise IT strategy, cybersecurity, and AI-driven innovation. With over 25 years of experience across the pharmaceutical, biotechnology, healthcare, and consulting sectors, he has successfully delivered large-scale technology initiatives that enhance operational excellence, regulatory compliance, and business growth. Prior to joining Reliance Life Sciences, Pranav held leadership positions at Piramal Enterprises and Infosys, building deep expertise in GXP Compliance, CSV, digital transformation, cloud technologies, enterprise applications, data analytics, and GxP-compliant systems. He has led the implementation of mission-critical platforms including SAP ERP, Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), Quality Management Systems (QMS), and cloud-first digital ecosystems. A strong advocate of responsible Artificial Intelligence, Pranav is driving the adoption of Generative AI, advanced analytics, and intelligent automation to accelerate scientific research, manufacturing, and business operations. Pranav is a frequent speaker on digital transformation, AI strategy, and technology leadership, sharing practical insights on building future-ready, data-driven enterprises.

 

 

Founder of TrustBridge Compliance

Sachin Bhandari has spent 25 years in pharmaceutical quality IT, with close to two decades in computer system validation. His work runs from CSV and GxP compliance across South Asia and the UK, through global validation governance at Boehringer Ingelheim, to direction of UCB Pharma’s global digital quality estate as Business Process Owner for Quality IT. He now advises regulated manufacturers and life-sciences software vendors through TrustBridge Compliance on the shift from document-heavy CSV to risk-based CSA, paperless validation, quality-system modernisation, and the validation of AI and machine learning for GxP.

STANDARDS AND INDUSTRY ROLES

—  Member,  Global GAMP Steering Committee

—  Draft Reviewer,  EU GMP Annex 22 (AI)

—  Contributor,  GAMP AI Special Interest Group

—  Former Chairman, GAMP India;  former Director, ISPE India

TRACK RECORD

—  25 years in pharmaceutical quality IT; close to 20 in computer system validation.

—  Zero critical regulatory findings across 300+ inspections (FDA, EMA, PMDA, WHO, TGA, ANVISA).

—  Global validation and quality-IT leadership at Boehringer Ingelheim, UCB Pharma and Sun Pharmaceuticals.

SELECTED WORK

Sachin’s work sits where regulation meets engineering. At UCB Pharma he directed the global Quality IT estate and put validated, inspection-ready AI to work inside live GxP processes — from deviation authoring and root-cause investigation to CAPA and predictive quality — with no Health Authority observations to date. At Boehringer Ingelheim he authored DiVAL, the enterprise move from document-heavy CSV to Computer Software Assurance across more than fifteen manufacturing sites, aligned to GAMP 5, EU GMP Annex 11 and 21 CFR Part 11. At Sun Pharmaceuticals he delivered an enterprise paperless validation platform and an automation-driven eQMS across forty-plus sites. The thread through all of it is the same: technology that makes quality faster, and evidence that holds up the moment an inspector asks.

FRAMEWORKS AND AUTHORSHIP

—  Creator of the DRIVE framework (CSV to CSA) and DiVAL (paperless validation).

—  Author, Validating AI in GxP: A Practitioner’s Guide (2026), with the companion AI Validation Cookbook series.

—  Author of the ‘Trends in CSV(A)’ newsletter (16,700+ subscribers).

RECOGNITION AND SPEAKING

—  70+ international presentations at ISPE, PDA, DIA and Veeva Summit.

—  Top 10 Innovator 2024 (AI in CSV).

EDUCATION AND CERTIFICATIONS

—  Doctoral research in progress — Validating AI Frameworks in GxP Environments.

—  MBA, Manipal Academy of Higher Education; B.Com, University of Rajasthan.

—  ISO 9001 Lead Auditor; ITIL v3; PMP (trained).

 

Senior Director – Quality, Emcure Pharmaceuticals

Chetananad Pathak is a seasoned pharmaceutical quality leader with over 28 years of experience across sterile and non-sterile APIs, oral formulations, and injectables. Currently serving as the Senior Director – Quality at Emcure Pharmaceuticals, he oversees corporate quality and compliance functions, ensuring global regulatory alignment and operational excellence.

Chetananad holds a Master’s degree in Microbiology and is a certified Six Sigma Green Belt. His expertise is backed by multiple credentials in leadership, critical thinking, and digital transformation. Over the years, he has led and managed inspections from top regulatory bodies including the USFDA, MHRA, ANVISA, TGA, and WHO.

Beyond operations, he has played a key role in vendor qualification programs, QAMS implementation, and API contract manufacturing oversight. He is also the author of “Hired”, a practical book offering insights and preparation tips for young professionals entering the job market.

Chetananad brings not just experience—but a deep commitment to fostering a quality-first culture in the pharma ecosystem.

 

Head – Information Technology, Inventia Healthcare Ltd.

Sanjay Nandavadekar is a passionate Information Technology executive with more than 20 years of experience in the Manufacturing – Pharmaceutical industry. Sanjay’s strategic leadership and certified skills in managing IT strategy, business process optimization, and creating a culture of cross-functional teams and his experience in SDLC have helped organizations achieve greater automation, efficiency improvements, and technology leadership using technology as a catalyst.

Sanjay has a proven track of leadership expertise in managing large enterprise projects targeted for process improvement, compliance, and greater ROI. His business relations with the vendor ecosystem and peer CIO network are helping him to stay abreast of technology trends. Sanjay is leading a portfolio of implementing cutting-edge technologies like Industry 4.0 (AI, IoT, RPA, Chatbot, NLP, BI, and Cloud) and has demonstrated the skill of owning high-volume budgets. Sanjay is a well-recognized individual in the industry and has received good recognition, and awards during his stint.

Principal eCompliance Specialist, Dr. Reddy’s Laboratories.

Yogesh C. Jagtap brings over two decades of deep expertise in Computer System Validation (CSV) and IT Quality Assurance, with a distinguished career spanning global consulting and leadership roles. He has spent 20 years in the field, including 8 years providing international CSV consulting to leading pharmaceutical and life sciences organizations.

His career includes pivotal roles at renowned Indian pharmaceutical companies like Ranbaxy, as well as global consulting firms such as Deloitte Touche Tohmatsu. Currently, he serves as the Global CSV Lead at Dr. Reddy’s Laboratories, where he manages the company-wide CSV/IT compliance program, ensures its conformance across the organization, and strives to keep it aligned with evolving regulatory expectations. He is committed to optimizing the compliance framework to balance IT regulatory requirements with the company’s digital transformation goals.

Sr. Director, Cognizant – Life Sciences Quality Engg. & Assurance.

Vinod brings over 24 years of leadership experience in the software industry, specializing in global delivery, transformation consulting, and quality engineering. As the Portfolio Delivery Lead for Cognizant’s Life Sciences QA division, he has successfully led large-scale transitions, Agile and DevOps transformations, and the establishment of Test and Quality Centers of Excellence across multiple global engagements. He is a recognized strategist in quality assurance, known for defining enterprise-wide QA frameworks, metrics, and governance models that drive measurable improvements in time-to-market and product quality. Vinod has authored several thought leadership papers on AI and automation, including “One Digital,” “AI-Driven Automated Failure Analysis & Resolution,” and “Intelligent AI – Driven through AI Hub.” A passionate advocate for innovation, Vinod is a frequent speaker at industry forums and holds certifications in Agile and Project Management. He earned his Bachelor of Engineering degree and continues to champion the integration of AI and GenAI into enterprise QA platforms.

Associate Director, Cognizant – Life Sciences Quality Engg. & Assurance

With nearly two decades of experience in the Quality Engineering domain, Kumaresan Lakkapuram Murugesan has been instrumental in driving transformation for Pharma clients. He has helped modernize validation processes by integrating tools, automation, artificial intelligence (AI), and Computer Software Assurance (CSA).Kumaresan has played a pivotal role in collaborating with large enterprise customers to adopt CSA and implement technological transformation initiatives. His strategic contributions have enabled organizations to optimize costs, accelerate validation cycles, and significantly enhance overall quality and compliance.

 

Director – Enterprise Platforms & Programs | Technology Site Leadership, AMGEN

With over 21 years of international leadership experience, Sushil Pathak has been at the forefront of designing, building, and scaling enterprise platforms that deliver measurable business impact. He specializes in technology strategy, large-scale transformation programs, and establishing Global Capability Centers (GCCs) and Centers of Excellence (COEs) across APAC, Europe, the US, and the UK.
Sushil has led multi-million-dollar global initiatives across life sciences, manufacturing, CPG, oil & gas, and BFSI—driving operational transformation, accelerating growth, and enabling sustainable innovation.
With leadership roles at Amgen, Reckitt, and Heubach, Sushil blends vision with execution to deliver measurable business impact.

 

SVP & CIO, Matrix Pharma Corp.

Krisna Sai T is a seasoned technology leader with over two decades of experience driving digital transformation, IT strategy, and enterprise innovation in the pharmaceutical and life sciences sector. As Senior Vice President & Chief Information Officer at Matrix Pharma Corp, he spearheads the organization’s technology vision — building scalable IT infrastructures, modernizing operations, and enabling business growth through digital excellence.

Prior to Matrix Pharma, Krisna Sai played a pivotal role at Biocon Biologics, where he successfully led the Global SAP Center of Excellence and IT Infrastructure. His expertise spans IT project and program management, SAP solution design, business process optimization, and enterprise digital strategy, making him a recognized voice in aligning IT with core business objectives.

A strong believer in leveraging technology as a growth enabler, Krisna Sai has been instrumental in fostering organizational efficiency, innovation, and resilience. His leadership has been recognized with multiple industry awards, reflecting his contribution to pushing the boundaries of IT in the bio-pharmaceutical domain.

At industry forums, Krisna Sai shares thought-provoking perspectives on digital transformation, future-ready IT ecosystems, and the evolving role of CIOs in driving business value.