Executive Director, IT Quality and Compliance, Gilead Sciences

Ken Shitamoto leads the IT Quality Engineering function at Gilead Sciences, which performs software quality assurance (testing), validation, and infrastructure qualification. He is a member of the FDA-Industry CSA team, and a co-author of the appendix bridging GAMP and CSA in the GAMP good practice guide on Data Integrity by Design. Ken is a multi-disciplined professional with extensive experience in quality engineering, quality management, project management, audits, and software development. He has been in the biopharmaceutical space since 1993 and has worked on the manufacturer (GXP), vendor (GCP), and consulting sides of the business.

He holds a BA Molecular Cell Biology and MS Computer Science and from UC Berkeley and San Jose State University respectively. He is an avid supporter of the American Lung Association and WeHope.org (homeless services).

Global CSV / eCompliance Lead, Dr. Reddy’s Laboratories

I have 20 years of experience in field of Computer system validation including  8 years of international CSV consulting experience. Worked for Indian generic giants like Ranbaxy and service industry leads like Deloitte. Currently working as Global CSV and eCompliance Lead at Dr. Reddy’s laboratories Limited.

Head of Quality and Compliance, Zydus Group

I have 20-plus years of rich experience in pharmaceutical companies in Global quality, corporate quality, Site Quality, and Production functions from Cipla, Aurobindo, Sandoz, Fresenius Kabi, Apotex, Lupin, and Zydus. I have detailed knowledge of GMP, GLP, GEP, and Regulations in the US and EU and general Quality Management. Demonstrated ability to interact with Competent Authorities effectively. Excellent leadership and communication skills. Strong drive for results and problem-solving skills with a solid scientific background. Directly involved in more than 50 successful regulatory inspections as a host. I have been involved in the quality culture development program and data integrity compliance program. As an auditor, I led 350 plus audits of which 200 plus as a Lead auditor across the globe. I have travelled to the USA, CANADA, MEXICO, GERMANY, HUNGARY, FRANCE, SPAIN, ITALY, the UK, JAPAN, CHINA, SINGAPORE, and IRELAND for Business meets and audits.

Head of Strategic Consulting, Compliance Group

Sarada Ramamoorthy brings over 17 years of extensive experience in the field of strategic consulting and compliance. Currently, she is Head of Strategic Consulting, at Compliance Group. Her career spans reputable companies such as Cognizant, iGATE, Accenture, and Excelra. She specializes in Computer System Validation and Computer Software Assurance, with profound expertise in quality management systems implementation, audits, and inspections. Sarada has a robust background in managing large multi-site programs, including digital transformations, infrastructure transformation, and multi-country ERP implementations like SAP S4 HANA on the cloud. She is adept in CSV/CSA methods, encompassing waterfall, Agile, and hybrid applications/systems across all GAMP categories.  She has established and operated compliance offices for clients, providing models such as Validation as a Service, Quality as a Service, and Compliance as a service.

Global Head, Quality IT, 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.

Head Quality Assurance, Unichem Labs 

Nitesh Gaonkar is a postgraduate in industrial and analytical chemistry from the Goa Institute of Management. He has over 20 years of experience in the pharma industry and he is presently working as head of quality assurance, at Unichem Laboratories. He had previously worked for Cipla, Glenmark, FDC & Pfizer. He has undertaken many projects as a project leader such as Track Trace Serialization at Unichem & Pfizer, Quality assurance Management Software & many more.

Sachin Bhandari, Head of CSV and Qualification Standards at Boehringer Ingelheim International GmbH, brings over 25 years of strategic IT leadership. His expertise lies in digitizing quality processes, managing complex IT projects, and ensuring regulatory alignment. Sachin has a proven track record in software quality, infrastructure qualification, GxP compliance, IT risk management, and program delivery across IT and pharmaceutical industries. His domain knowledge in e-compliance is robust, particularly in GXP, 21 CFR Part 11, Annex 11, and GAMP 5 projects.

Sachin’s leadership extends beyond the corporate realm. He served as a member of the Board of Directors for ISPE India Chapter from 2020 to 2022 and was the ex-chairman of ISPE GAMP India Steering, the apex body of CSV and e-compliance professionals from 2018 to 2020. In international forums, Sachin has spoken in over 65+ conferences, sharing insights on CSA, cloud computing, and AI. His commitment to advancing compliance practices and fostering innovation underscores his impact in the industry.

With over 23 years of IT experience, Ragavan, the Delivery Head of Client Services at Archimedis Digital, brings a robust background in Quality Engineering and Compliance. He specializes in Client Services and Portfolio Management and has established Testing Centers of Excellence for global pharmaceutical clients. As a hands-on techno-functional leader, he has successfully delivered solutions aligned with the latest digital trends. His current interests include developing GxP frameworks on GenAI and AI/ML platforms.

Rangarajan has over 2 decades of experience in the Life Sciences domain, he serves as a Principal Consultant for Products & Solutions at Archimedis Digital, where he drives the creation and implementation of cutting-edge digital solutions for the industry. Renowned for his expertise in product management, presales, and delivery, he has successfully developed solutions like eCapsule, an Industry 4.0 smart factory solution for Pharma manufacturing. His leadership in complex global transformation projects has significantly improved quality and compliance for clients. Passionate about strategic innovation and agile methodologies, Rangarajan consistently delivers impactful, future-ready solutions for the Life Sciences sector.

Mr. Agnidipta Sarkar is the Vice President of CISO Advisory at ColorTokens, which specializes in breach-ready cyber defence solutions. 

With over 30 years of experience in cybersecurity, crisis management, privacy, and risk optimization, Agni assists organization leadership in building digitally resilient infrastructures capable of scaling with business growth and withstanding cyberattacks. His expertise lies in advocating for zero trust and digital resilience principles across on-premises, cloud, and OT/ICS environments.

Previously, he served as the Group CISO at Biocon, a global biopharmaceutical company, where he enhanced digital resilience and cybersecurity capabilities to support business and digital transformation initiatives. He adeptly balanced economic and cyber risks, streamlined operations, and ensured a safer digital capability for business leaders.

An active contributor to industry forums and standards bodies such as ISO, BCI, and CSA, Mr. Sarkar is a recognized evangelist and a zero-trust ambassador.

Nandhini Natarajan is the Validation manager in Sikich.

Nandini has an Engineering Degree in Biotechnology specialization from Anna University, Chennai. She is in the Computer System Validation purview for over 12 years now. Her expertise as consultant in leading multi-national organizations has ensured over 50 successful project implementations under her belt. She is a SME in Life sciences value Chain, FDA Guidelines and Agile Methodology.

As a subject matter expert in Computer system Validation, Nandhini works along with multiple pharmaceutical, biotechnology and medical devices organizations to understand the elusive situations and brings in efficient solutions for a compliant and cost-effective business processes.

Her extensive hands-on knowledge in TrackWise on premise and TrackWise Digital, Veeva Vault, AEGIS and ServiceNow tools and expertise in HP ALM, ValGenesis, JIRA and TestRail enables her to provide competent solutions to the regulatory challenges faced by the customers in Quality management, Resource management and Pharmacovigilance areas.

Venkata Naga Prasad Vaitla is a visionary technology leader with over 31 years of experience. Currently, he is working with Cadilla Pharmaceuticals as Senior Vice President of IT Developments – Head. He boasts an exceptional track record in managing enterprise systems, spearheading digital transformations & fortifying IT infrastructure, enhancing cybersecurity, and overseeing vendor management. His multifaceted background equipped to navigate and lead complex technological landscapes, ensuring sustainable success and innovation.

Munish Sharma is the head of CSV at Arcolab Pvt Ltd, an ISO-certified Global Capability Centre specializing in life science services. With a well-rounded 29-year career in the digital ecosystem of IT, CSV, and compliance within the pharmaceutical industry, Munish brings extensive expertise to his role. His professional journey includes associations with leading pharma companies such as Sun Pharma, Ranbaxy Labs, and Strides Pharma Science. He leads a dynamic team of over 40 CSV subject matter experts, driving innovation through a CSA-themed, technology-centric solution in CSV. With a strong focus on customer-centricity and delivering excellence, Munish has established a robust digital compliance infrastructure for Enterprise IT and ITeS across manufacturing, R&D, and corporate sectors.

Rishabh Tripathi brings nearly 17 years of experience in the pharmaceutical commercial sector. Beginning his career as a medical representative at Ranbaxy, he transitioned to Business Analytics in 2007, contributing his expertise to companies like Mu-Sigma, Genpact, WNS, ZS Associates, and GSK.

As the BI Lead for GSK’s Emerging Markets, Rishabh leverages data to enhance commercial decision-making. He excels in setting up incentive compensation schemes, driving forecasting and valuation, implementing the latest reporting platforms and technologies, and pioneering persona-based analytics reporting for stakeholders ranging from CXOs to medical reps. Rishabh is committed to ensuring high data integrity, availability,
usability, and security, maintaining regulatory compliance, and fostering organizational trust through informed decision-making.