Dr. David W. Vincent

Chief Scientific Officer(CSO) of VTI Life Science.

Dr. Vincent has over thirty-four (34) years of experience in the healthcare industry specializing in the Biotechnology and pharmaceutical industries. He has over (29) twenty-nine years dedicated to the field of Commissioning, Qualification, and Validation (CQV) He has B.Sc. degrees in industrial microbiology, as well as a Master of Public Health and Ph.D.

He has hands-on experience in many areas of Regulatory Affairs, Quality Assurance, Commissioning/Qualification, and Engineering including regulatory submission preparation, Cleanroom Design Review, Microbiology Laboratory setup and qualification. He is solid in Upstream and Downstream Process Development and Validation. He is a leading expert in developing and implementing Cleaning Development and Validation, Aseptic Process, Contamination Control, and Environmental Monitoring Programs. Most of his career has been in the biological vaccine industries but he has also supported the Medical Device, Biopharmaceutical, Pharmaceutical, Nutraceutical, and biological industries.

Dr Vincent is an ASTM committee member for Manufacture of Pharmaceutical and Biopharmaceutical Products - E55 (20-07), Microbial/Sterility Assurance for Pharmaceutical and Biopharmaceutical Products - E55.06 (20-01), WK74412 - New Standard Critical Airflow Visualization and WK69826 - Standard Template for Environmental Monitoring Trend Analysis, Best Practices for Microbial Control of ATMP, and Cleaning Quality by Design, and Risk-Based Cleaning. He co-authored the ISPE GUIDE: Cleaning Validation Lifecycle – Applications, Methods & Controls. ASTM Led for Developing and Managing Contamination Control Strategy.

He taught at San Diego State University (SDSU) for their Masters of Regulatory Affairs Degree program in the Field of Validation Technology RA-776. Inducted into Delta Omega Honorary Society in Public Health was founded in 1924 at Johns Hopkins University within the School of Hygiene and Public Health to promote the graduate study of public health, and to recognize outstanding achievement in the new field.

Mr. Jayakumar A V

President Quality - Ajanta Pharma Limited

Mr. A V Jayakumar has completed his master's in analytical chemistry from Sardar Patel University, V V Nagar Anand, Gujarat. He is a senior quality and compliance professional with over 28 years of experience. He started his career with Torrent and subsequently associated with Cipla, Aurobindo, USV, and Glenmark. At present, he is responsible for the global quality operations of Ajanta Pharma Ltd.

He is an expert in evolving sites from scratch to meet all SRA compliance requirements. He is also skilled at delivering training and has conducted several audits in India and overseas. He has executed several digital transformation programs at his current organization, making laboratory and manufacturing operations are paperless.

During his career, he dealt with all stringent regulatory authorities during inspections, preparing responses and their ongoing compliance program.

Mr. Subhrangshu Chaudhury

Vice President & Head of Quality - Centaur Pharmaceuticals Pvt. Ltd

Mr. Subhrangshu Chaudhury is a seasoned professional with over 17 years of extensive experience in the pharmaceutical industry. He is currently the Vice President & Head of Quality at Centaur Pharmaceuticals Pvt. Ltd. Having a strong background in Regulatory and Quality in the pharmaceutical industry. His experience in working with global customers and suppliers has enabled him to adopt global approaches to his work. In his current role as the Vice President and the Head of Quality for MNCsCentaur Pharmaceuticals Pvt. Ltd, Mr. Chaudhury heads all quality-related functions. He has held positions at reputable organizations such as Alembic pharmaceuticals Ltd, Astron Research Limited, Sequent Scientific Limited, USV Limited, and Indchemie Health Specialties Pvt. Limited, solidifying his expertise in the pharmaceutical industry and quality management. With his comprehensive experience and leadership skills, he continues to make significant contributions to the advancement of quality and regulatory standards in the pharmaceutical sector.

Mr. DVS Varma

Vice President-Quality-Sai Life Sciences Ltd

Varma DVS, did his post graduation in chemistry and carries rich experience of working in the Pharma industry in various disciplines and capacities for 29+ years.

He is currently associated with “Sai Life Sciences Limited” since 2000, prior to which he was associated with “Siris India Limited” between 1994-2000.

He is Instrumental in establishing the Quality Systems across product life cycle and ensure compliance of Quality Systems. Expertise in handling Regulatory as well as client inspections. Hands on experience in implementation of electronic systems to handle Quality systems.

He has handled 500+ customer audits, 10 USFDA audits, 2 PMDA audits and 1 Cofepris audit at Sai Life Sciences Limited.

He has also played an active role in publication of Sai's case study of Technology Transfer process in the 3rd edition of Good Practice Guide on Technology Transfer of International Society for Pharmaceutical Engineers (ISPE).

Dr. Kiran Kota

Head - Cluster Quality & RA - Harman Finochem Limited

Dr. Kiran Kota has more than 24 years of experience in Quality Management Area in Pharma Industry & currently he is working with Harman as a Vice President of Quality.

He is handling Quality and Regulatory Affairs department under his portfolio and around 400+ people are reporting to him directly/indirectly. Previously associated with major pharma players like Mylan, Natco, Aurobindo Pharma, Emcure Pharmaceuticals & SMS Pharma.

Mr. Kamaraj Abraham

Associate Vice President and Head Quality - Aurobindo Pharma

Kamaraj Abraham, is a Postgraduate in pharmaceutical technology, Vinayaka Mission University, India., having about 27 years of experience in Managing Quality operations in Leading organizations like Shasun chemicals, Alembic Pharma, Dr. Reddy’s, Actavis Pharma, Aurobindo Pharma, etc. Present assignment is as Associate Vice President - QA with Aurobindo Pharma Limited, wherein responsible for a plant Quality function. He has versatile expertise in major quality related functions like Quality Assurance, Quality Control, Analytical development and Regulatory affairs. He is well established as a Quality Leader in terms delivering all Quality System requirements. He has proven track record of facing various regulatory audits like US FDA, UK, MHRA, ANVISA successfully and instrumental in creating leadership team under his guidance to meet individual and organisational goals.

Mr. Divyesh SC

Sr. Manager BD
Pragvas Technologies

Divyesh holds a master’s in business administration from South Gujarat University, Gujarat and is a seasoned sales professional with over 13 years of experience. Currently, he oversees global sales operations at Pragvas Technologies LLP.

Specializing in Level 2 Integration and Cleaning Validation within pharmaceutical manufacturing, Divyesh focuses on optimizing these critical areas to drive digital transformation and operational excellence. His expertise also includes integrating Quality Management Systems (QMS) and Manufacturing Execution Systems to support overall digital transformation. His diverse experience in sales, project management, and strategic marketing has greatly contributed to the success of his clients in healthcare and life sciences. He has spearheaded several digital transformation initiatives, optimizing sales processes and enhancing customer engagement through innovative technologies.

With a robust background in strategic business development and extensive C-level contacts, Divyesh facilitates long-term relationships and guides industry leaders through their digital journeys. His role involves initiating and nurturing these relationships to foster collaboration and innovation within the pharmaceutical industry.

Dr. Vivek Chaudhari

Vice President Corporate Quality
Harman Finochem

With nearly 30 years of leadership experience, I am a seasoned professional specializing in Quality Control operations, regulatory compliance, and manufacturing process optimization for both sterile and non-sterile environments. My expertise encompasses risk management, inspection management, and the integration of automation in quality systems and laboratories. I excel in overseeing management escalations, field alert reporting, and recall management.

Compliance Leadership: Expert in leading compliance investigations, addressing inspection observations, managing 483s, and implementing corrective and preventive actions (CAPA). I ensure CAPA effectiveness through thorough follow-ups. Quality System Remediation: Proficient in handling out-of-specification (OOS) and out-of-trend (OOT) results, conducting root cause analyses, and preparing subject matter experts (SMEs) for regulatory interactions. Laboratory Oversight: Skilled in conducting retrospective reviews of laboratory OOS investigations, reducing human error, and enhancing laboratory operations and compliance. Analytical Development and Quality Assurance: Experienced in quality assurance for APIs and formulations, managing quality system inspections, audits, compliance reviews, and third-party activities. Quality Transformation: Lead initiatives to identify and optimize weak processes through comprehensive product assessments and statistical evaluations. Project Leadership: Contributed to greenfield projects, including sterile carbapenem production, OSD facilities, API facilities, and global transfer projects. Risk Assessment and Containment: Spearhead product and line risk assessments and containment studies for critical manufacturing sectors, such as cytotoxic and sex-hormone production.

My extensive background equips me to drive quality and compliance improvements, ensuring robust and efficient pharmaceutical manufacturing processes.

Mr. RL Prasad

Head Data Analytics
Sai Life Sciences Limited

Mr. RL Prasad, did his post graduation in chemistry and carries rich experience of working in the Pharma industry in various disciplines and capacities for 20 years.

He is currently associated with “Sai Life Sciences Limited”, before which he was associated with “Divis Laboratories and Aurobindo Pharma Limited”. He is Instrumental in establishing the Quality Systems across the product life cycle and ensuring compliance of Quality Systems.

Hands-on experience in the implementation of electronic systems to handle Quality systems. He has also played an active role in developing AI/ML models in various business use cases in Pharma Industry including manufacturing process.

Thomas Altmann

Principal Global Technical Consultant
Life Sciences Limited

Thomas has 25 years’ experience in cleaning chemistry, cleaning process, cleaning validation and regulatory compliance. As Global Technical Consultant, he provides technical consultation on cleaning and sanitization processes, optimization for pharmaceutical, API, biotechnology and personal care manufacturers in Europe, Middle East, Asia Pacific, North America and Africa. In his role Thomas is a subject matter expert in cleaning validation for product contact surfaces across all types of pharmaceutical and personal care production equipment. He is also a member of ASTM E55 WK15778 Cleaning Process Development & Validation Team and worked on ASTM E3106 Risk-based Cleaning Validation Process Standard what was published March 2018. Thomas is an active member of Parenteral Drug Association (PDA) and working on Cleaning Validation Process updates like the Technical Report 29.

Ashutosh Kumar Sinha

Chief Quality Officer
Neuland Labs

With over 28 years in the pharmaceutical industry (API and Formulation) specializing in Quality Management. Roles include Chief Quality Officer at Neuland Labs Ltd, Quality Head of Small Molecules at Syngene International Ltd, Quality Head at Symbiotec Pharma Lab, Cluster Quality Head at Dr. Reddy's Laboratories Ltd, QA Head at Glenmark Pharma Lab, and Ranbaxy.

Extensive knowledge of pharmaceutical manufacturing processes, Good Manufacturing Practices (GMP), and expertise in Cleaning Validation, Process Validation, and Investigations. Proficient in regulatory requirements (FDA, EMA, TGA, etc.) and Quality Systems.

Demonstrated success in leading and mentoring quality teams with strong decision-making skills and a strategic approach to driving quality improvements and ensuring compliance.

In-depth expertise in regulatory guidelines and standards for the pharmaceutical industry, including inspections, audits, and submissions.

Proven ability to address and resolve quality issues effectively, implement corrective and preventive actions, and foster a culture of continuous improvement.

Vishalakshi Naik

GMP Auditor & Founder
Quality Solutions

Vishalakshi Naik is a former microbiologist at Raptakoss-Bret. After two decades in corporate roles at Bohringer, Nicholas, and Servier, she founded Quality Solutions in 2007. Her mission is to serve more companies efficiently while maintaining a balance between work and family.

Several pharma executives have benefited from Vishalakshi’s expertise, as she simplifies complex GMP concepts for practical application. Quality Solution is into consulting, training & vendor Qualification, they conduct Audits across the world.

Additionally, she established CCRT to train pharma & medical professionals in Clinical Research, and also successfully conducted phase 4 trials for MNCs.

She is passionate about culture-building and strengthening GMP habits, and Vishalakshi coaches’ top industry executives. With more than 35 years of experience, her focus remains on helping executives of the pharma world achieve their goals with ease.