Dr M Damodharan

Chief Quality Officer - Sai Lifesciences Ltd.

Dr. M. Damodharan holds a doctorate in Analytical Chemistry and carries rich experience working in the Pharma industry in various disciplines and capacities for over 28 years.

He is currently associated with Sai Life Sciences Limited since 2014, prior to which, for almost a decade, he was associated with Ranbaxy Laboratories Ltd., as Head-API Global Quality. His professional journey includes assignments with GSK, Max Pharma, and Shasun Pharmaceuticals Ltd.

He has vast expertise in handling regulatory inspections like USFDA, KFDA, TGA, MHRA, PMDA, etc.

He is the pioneer in establishing electronic systems and digitalization at Sai Life Sciences Limited. Under his leadership, “Sai” has received the most prestigious “Golden Peacock National Quality Awards - 2020” for world-class Quality systems and practices and the implementation of Learning technologies & best L&D practices. His Training, Learning Technologies, Learning & Development initiatives have bagged “Golden Peacock National Training Award,” 2 ATD Excellence in Practice Awards, Brandon Hall Award, and LearnX Award in 2021. He is also a proud recipient of “Learning Leader of the Year-2020”, awarded by Invention, Asia for his extraordinary feats in L&D. He is a Board Member of ISPE and an active member in many customer advisory boards and Pharmaceutical technical committees.

Igor Gorsky

Principal Consultant - ValSource

Igor Gorsky has been a pharmaceutical industry professional for over 35 years. He held multiple positions with increasing responsibility at Alpharma, Wyeth and Shire and has worked in Production, Quality Assurance, Technical Services and Validation, including as an Associate Director of Global Pharmaceutical Technology at Shire. He is currently holding a position as a Principal Consultant at Valsource. He is leading the PDA Water Interest Group. He is also leading the PDA Task Force for a revision of PDA TR 29: Points to Consider for Cleaning Validation. In addition, he is a member of ASTM E55 and one of the authors of ASTM E3106 and E3207. He is the author of several books, namely Principles of Parenteral Solution Validation (2019) and one of the authors of Pharmaceutical Process Scale-Up (1995, 2000, 2005).

Sanjeev Mahajan

Vice President Quality - Cadila Pharma

Sanjeev Mahajan is a highly accomplished and dynamic Pharma Professional with an impressive career spanning over 30 years. He has held significant roles in several reputable and GMP compliant pharmaceutical companies, including Ranbaxy, Sun Pharma, Symbiotec Pharmalab, and Aurobindo Pharma. Currently, he serves as the Vice President of Quality at Cadila Pharmaceuticals Limited.

Throughout his career, he has amassed rich experience in handling regulatory audits, having successfully managed inspections from esteemed authorities such as US-FDA, MHRA, TGA, WHO, and PMDA. His expertise extends to designing and establishing new facilities, where he excels in facility qualification, equipment qualification, cleaning validation, and quality system implementation.

With his extensive knowledge and leadership skills, he continues to make significant contributions to the pharmaceutical industry, ensuring adherence to stringent quality standards and regulatory compliance. His unwavering commitment to excellence has earned him a reputation as a respected and reliable professional in the field.

Dr. J P Khurana

Quality and Regulatory Consultant

Dr. J P Khurana is a distinguished Quality and Regulatory Consultant with a Ph.D. in Medicinal Chemistry from Panjab University, Chandigarh. With nearly 30 years of comprehensive experience in the pharmaceutical industry, he possesses unmatched expertise in establishing quality systems, conducting investigations, managing regulatory inspections, and leading remediation projects. His proficiency extends across various pharmaceutical products, including API and Drug Products and his extensive international exposure in countries such as the USA, Japan, Canada, and others has honed his global perspective and knowledge of diverse regulatory guidelines.

He has previously worked for organizations like Ranbaxy, NIPER and Sun Pharma. He currently serves as the Vice President - Corporate Quality at Lupin..

He has also authored 11 research publications related to Semisynthetic Antibiotics in esteemed research journals in the USA, Germany, Japan, UK and India.

Thomas Altmann

Global Technical Manager - Ecolab

Thomas is a highly accomplished RDE Service Engineer & Cleaning Validation Manager with over 20 years of experience in optimizing and validating cleaning processes in the pharmaceutical, biotechnology, and personal care industries. He holds a state certification as a food chemist from the University of Wuppertal, Germany. His expertise is recognized globally as he actively participates in various standard-setting organizations, including the ASTM E55 WK15778 Cleaning Process Development & Validation Team, which published the new risk-based Cleaning Validation Process Standard in March 2018. He is also an active member of the Parenteral Drug Association (PDA) and has contributed to updates in Technical Report 29 (2019).

As a Global Technical Manager, Thomas provides invaluable technical consultation to pharmaceutical, API, biotechnology, and personal care manufacturers across Europe, Middle East, Asia Pacific, and Africa, assisting them in optimizing their cleaning processes. With extensive experience in cleaning validation for product contact surfaces, Thomas has developed more than 1500 cleaning programs and recommendations over the past five years. His expertise extends to addressing regulatory inspection findings related to cleaning processes, implementing corrective and preventive action (CAPA) plans to prevent re-occurrence.

Thomas's contributions to the industry go beyond consultancy, as he regularly shares his knowledge and insights through presentations and workshops for renowned organizations such as ISPE (International Society of Pharmaceutical Engineering), Informa LifeScience, VDMA, and FDANEWS. Additionally, Thomas has co-authored articles in respected publications such as "Pharmaceutical Engineering," "Pharmaceutical Online," and "Biotechnology Online," showcasing his thought leadership and expertise.

Prior to joining Ecolab, Thomas garnered valuable experience in the healthcare/pharmaceutical and food industries, further enriching his depth of knowledge in cleaning chemistry, cleaning process optimization, and regulatory compliance.

Abhijit Kulkarni

Vice President - Corporate Quality Assurance
Lupin

Abhijit is a Seasoned Quality professional offering around 28 years of enriching experience, having worked in leadership roles with reputed pharmaceutical companies covering multiple dosage forms, products, technologies, and functions. I am presently working as "Vice President-Corporate Quality Assurance" at "Lupin Ltd., Mumbai, India".

For his outstanding contributions in implementing improved quality processes and demonstrating efficiencies in steering Quality Operations across a wide span covering new and mature sites, regional operations, external / contract manufacturing, and commercial operations, he has been awarded the citation of "SO Most Talented Quality Professionals of India" across all manufacturing & service industries in India in 2014 by World Quality Congress". As a senior professional, he is deft in looking after the Corporate Governance processes like Monitoring Business Competencies, Risk Management, Legal & Regulatory Compliance, Issue/ Crisis Management, and Due Diligence.

He has served as a Certified Auditor and a Trainer, having proven competencies in Auditing, and Capacity Building, Strategy Deployment. He has handled audits from multiple agencies like Indian FDA, WHO, MHRA, FDA, AFSAPPAS, etc. He is well conversant with Six Sigma & Operational Excellence principles & their applications and has proven achievements in commissioning & qualifying new sites & putting them in operation. He has trained many professionals on Qualifications & Validations and Quality Management Systems

Bhavish Agarwal

Founder
FDAlytics

Bhavish Agarwal has a background in Software Engineering and Machine Learning. He has experience in working in the top technologies companies of the world and worked on some cutting-edge Machine Learning problems in the field of Natural Language Processing. Bhavish started Fdalytics where he and his team are using ML and data to improve the GXP compliance and regulatory process for the Life Sciences companies.

Dr. David W Vincent

Chief Scientific Officer (CSO)
VTI Life Sciences

Dr. Vincent brings over 34 years of healthcare industry expertise, specializing in Biotechnology and Pharmaceuticals. With a focus on validation (C&Q), he boasts 26 years of dedicated experience. His educational background includes B.Sc. degrees in industrial microbiology, a Master of Public Health, and a Ph.D. His hands-on proficiencies span Regulatory Affairs, Quality Assurance, Commissioning/Qualification, Engineering, and more, including Cleanroom Design, Microbiology Lab setup, Process Validation, and Project Management.

His strengths encompass Upstream and Downstream Process Development, Aseptic Process Implementation, and Environmental Monitoring Programs. His career spans biological vaccine, pharmaceutical, Medical Device, Biopharmaceutical, and biological industries. For 27 years, Dr. Vincent has provided validation and quality consulting, both nationally and internationally. He's an active ASTM committee member, contributing to standards like Microbial/Sterility Assurance and Aseptic Training. He co-authored the ISPE GUIDE: Cleaning Validation Lifecycle. He also instructs at San Diego State University for their Masters of Regulatory Affairs program.

In summary, Dr. Vincent's extensive experience, diverse expertise, and commitment to industry advancement make him a driving force in healthcare.

Amit Verma.

General Manager- Quality
GSK

Amit is a competent self-motivated Pharma Professional with over 26 years of authentic, motivational, and inclusive leadership and on a journey to make a difference to people’s lives. His career comprises of rich multi-functional experience in reputed pharmaceutical companies including various leadership roles in areas like Quality, Regulatory Affairs, Manufacturing, handling of Greenfield projects and Remediation.

Currently, he is Quality Director at a GlaxoSmithKline site which produces more than 15% of total GSK volumes globally. He is motivated by meeting the needs and trust of patients who rely on us every day for quality medicines and believes in leading from the front with a proven track record in delivering transformation by building efficient quality systems and an ability to drive quality culture and team performance.

Mala Sivaramakrishnan

Director - Site Quality
Cipla

Mala Sivaramakrishnan is a seasoned quality professional with over 30 years of experience in the global pharmaceutical industry. She currently serves as the Director of Site Quality at Cipla. In addition to her role at Cipla, she has held leadership positions at Hikal and Biocon, focusing on quality and regulatory affairs.

With a background in quality (QC, QA), regulatory affairs, development quality, operations, compliance, remediations, and vendor management, Mala has led teams of highly qualified professionals. Her career has been dedicated to the pharmaceutical field, driven by the mission of "caring and curing" lives. She feels privileged to contribute to a renowned organization that values quality and better patient health.

As a site leader, Mala's responsibilities include finding solutions to challenges, motivating teams, and promoting excellence in the noble profession of healthcare. She has been instrumental in implementing automation best practices and refining procedures to enhance quality and productivity. Mala is also dedicated to coaching future leaders in quality.
Mala's expertise has been acknowledged through successful regulatory inspections and numerous customer audits worldwide. Beyond her routine responsibilities, she has chaired conferences, delivered impactful presentations, and contributed to industry-academia programs. She has also been recognized for her leadership in professional associations and has actively engaged in CSR initiatives for health and education.
Mala's commitment to education, coaching, and collaboration shines through her continuous efforts to engage with internal and external stakeholders. She aims to resolve problems, ensure compliance with global regulations, and maintain supply security while learning and applying industry best practices.

Dr. Praveen Cherukupalli

Senior Vice President & Head - API & Process Analytical R&D
Innovare Labs

Dr. Praveen Cherukupalli comes with 23 years of rich experience in API process development and has been associated with pharma companies like Dr. Reddy’s laboratories, Raks Pharma, Granules Omni Chem and Honour Lab Ltd. He is Gold Medalist in M.Sc Org Chemistry from Osmania University and has 35 international publications & Patents from his past research work. Dr. Praveen did his Ph.D from NCL-PUNE and Post-doc from University of Texas in Organic Total Synthesis.

Dr. Praveen Cherukupalli joined Innovare Labs in 2022 as Senior Vice President & Head-R&D and is responsible for the Research and Development, Technology Transfer, Pilot Scale executions and DMF filing.

His area of expertise includes API process development, Novel and non-infringing synthesis, Nitrosamines expert, Process scale-up, QbD based process development, Technology Transfer, Expert in Plant Troubleshooting, Plant Validations, Commercial Production and Regulatory filings.