+91 76663 51726conference2017@iaia.org.inContact Hitesh Asrani

Conference on Regulatory Compliance and Emerging Technologies for Pharmaceutical Laboratories










NAME : P. SANATH KUMAR GOUD
Title: Associate Director – AR&D
Degree: Ph.D., (Chemistry)
Specialization: Chromatographic Method Development and Validations, Purification techniques, Characterization of the molecules by NMR spectroscopy and Mass Spectrometry.










Dr. Sanath Kumar joined USP–India in June 2011. He has 16 years of experience in pharmaceutical industry that includes 6+ years association with USP. Before joining USP, he served in a key technical position at ADVINUS Therapeutics Bengaluru, Prior to that he worked with Aurobindo pharma at Hyderabad. He has worked in different area of pharmaceutical developments including analytical developments/validations, isolation and characterization of unknown compounds, degradation pathways, structure-activity relationships, GLP compliance and laboratory management.

Dr. Sanath Kumar is Associate Director for Research and Development at the USP facility in Hyderabad, India. In his current position he directing the Process analytical and Isolation & Characterization laboratories. Apart from this, he is also responsible for the AR&D activities for development of reference standards pertaining to USP NF and FCC. He closely works with USPRockville and International sites for Reference Standards activities.

Dr. Sanath has received his Ph.D. degree in Organic Chemistry from Jawaharlal Nehru Technological University, Hyderabad, India and has authored more than 20 peer reviewed scientific publications of Analytical and Organic Chemistry and presented few posters in professional conferences.
Name & Degree : Sharad D. Mankumare, Ph.D.
Organization : United states Pharmacopeia – India (P) Ltd, Hyderabad
Presentation Title : Advances in chromatography / Method validation, verification and transfer











Biographical Information

Dr. Sharad Mankumare is a Director of Reference Standards Laboratory and Verification Programs at the USP facility in Hyderabad, India. He is responsible for the collaborative testing of reference standards for the USP NF, medicinal compendia and food chemical codex.

Dr. Sharad joined USP-India in June 2012. He has more than 20 years of experience in generic pharmaceutical industry. Before joining USP, Dr. Sharad has worked with several company includes Cipla, German Remedies, Glenmak and Sandoz (Novartis).

He is a FDA certified technical personnel for chemical and instrumental analysis. Dr. Sharad is holding Ph.D. in chemistry and Master’s degree in Organic chemistry from Mumbai University. He has published more than 05 scientific articles in international and national journals.
NAME : P. RADHAKRISHNANAND
Title : Associate Director
Degree : Ph.D., (Chemistry), MBA
Specialization : Method Development and Validations, Chiral Chromatography, Mass Spectrometry and Hyphenated Techniques











Dr. P. Radhakrishnanand is Associate Director for Research and Development at the USP facility in Hyderabad, India. He is working in Compendial Development Laboratory carries out the modernization of USP’s documentary standards through the monograph modernization process. He has more than 16 years of industrial experience where he has successfully accomplished projects on analytical methods development and validations for raw materials, intermediates, API and finished products. He also possesses expertise in Quality Assurance and laboratory management.

He has been associated with USP for about 10 years where he also worked for qualification of reference standards. In his current role of Associate Director-Compendial Development Laboratory, he is responsible for modernizing the monograph methods for chemical medicine with current technological advances. He closely works with USP-HQ and International sites for Compendial Development activities.

Radhakrishnanand has authored more than 20 peer reviewed scientific publications. He has received his Ph.D. degree in Analytical Chemistry from Jawaharlal Nehru Technological University, Hyderabad, India. He has also received his MBA degree in Marketing from Osmania University, Hyderabad, India.
Name & Degree : K. Kalyana Seela, Ph.D.
Organization : United States Pharmacopeia
Title of Talk : Packaging Systems for Therapeutic Products: Extractables and Leachables Standards












Biographical Information

Dr. K. Kalyana Seela joined USP-India in January 2011 and since that time she has served as the scientific liaison. Before joining USP, Dr. Seela worked at Vimta Labs as a Group Leader in Drugs Division where she was leading the teams responsible for Analytical Method Development for drug substances & drug products, Method Validation, Characterization, and Reverse engineering. She has also worked at Matrix Laboratories (a subsidiary of Mylan Laboratories), as Executive in analytical method development and characterization of APIs and at Biological E Ltd as an Assistant Manager involved in the peptide synthesis for the conjugation of vaccines.

Prior to working in the industry, Dr. Seela was a postdoctoral fellow at University of Nebraska developing column materials for bio separations and at Indian Institute of Chemical Technology developing nanomaterials for drug delivery systems.

Dr. Seela received a Ph.D. in Catalysis from Indian Institute of Chemical Technology, Hyderabad, and M.Sc. Chemistry from Andhra University in India. She also has completed a certificate course in Statistical Quality Control and holds a Six Sigma Green Belt from Indian Statistical Institute, Hyderabad.
Name & Degree : Dr. Amit Biswas, Executive Vice President .
Organization : Dr. Reddy’s Laboratories Ltd.
Title of Talk : Integrated Product Development (IPDO)












Amit has 24 years of diverse and rich international experience, spanning academic and industrial research, product development, technical service and management of research & technology in the areas of pharmaceuticals, engineering polymers and plastics, high performance fibers and coatings, and alternate energy technologies. He worked earlier with companies like DuPont (USA), ICI India and GE Advanced Materials.

Prior to joining Dr. Reddy’s, he worked with Reliance Industries as Senior Vice President, Technology Services & Emerging Technologies - Reliance Technology Group, and was responsible for design and implementation of Research & Technology Management processes, Business Transformation & Change Management, including Safety, Health & Environment, and interfacing with private/public institutions on Alternate Energy Technologies.

Amit is a Master Black Belt in Six Sigma (GE Certification). He is also a member of various councils viz. National Chemical Laboratory (Pune) Research Council, Indian Institute of Chemical Technology (Hyderabad) Research Council and IIT Bombay Advisory Council. Recently, he was made an Adjunct Professor at the IIT Bombay Centre for Research in Nano-technology & Science. Amit has 44 international publications, 3 book chapters and 4 patents.

Amit is a Ph.D and Masters in Polymer Science from Case Western Reserve University, Ohio, USA; and a Bachelor of Technology in Chemical Engineering from Indian Institute of Technology, Bombay.
Name & Degree : Dr. Aniruddha J. Vaidya, Ph.D.
Organization :
Title of Talk :












Dr. Aniruddha Vaidya has over 26 years analytical chemistry experience with in-depth knowledge of separation techniques and pharmaceutical analysis. He has exposure to Quality Assurance and various regulatory audits including those of USFDA, MHRA, WHO, TGA, MCC, etc.

Before joining Analytical Solutions, he was head of Analytical development team in Cipla and member of corporate QA team. He also led Sitec, a contract research organization and was involved in set up of BA/BE study centre as well.

Since joining Analytical Solutions he has held the position of Director. He is involved in managing the country wide trade and industry projects designed to develop and promote new analytical technologies and methods for analysis. These have involved extensive collaborations with industry, Universities and Regulatory Authorities. He has led the team at Analytical Solutions for 5 consecutive USFDA audits till now successfully.

He is member of Technical and Regulatory sub committee of Indian Drug manufacturer’s Association and involved in the support to Indian Pharmacopoeia Commission. He participated in writing SOP’s for reference standards, General Chapter for Related Substances and review of monographs.

He had been nominated as industry faculty by Mumbai University for the course of Master of Science in Bioanalytical Chemistry.

He has presented thoughts and views about issues in regulatory guidelines on bio analytical methods, analytical method development and validation, Extractable & Leachable studies in various Indian and International conferences.
Name & Degree : Mr. Ganadhish Kamat, Executive Vice President and Head of the Global Quality Organization
Organization : Dr. Reddy’s Laboratories Ltd.
Title of Talk :












Ganadhish Kamat is Executive Vice President and Head of the Global Quality Organization at Dr. Reddy’s. He joined Dr. Reddy’s in April 2016 from Lupin Limited.

Ganadhish brings with him over three decades of experience in various leadership roles in the pharmaceutical industry. At Lupin, where he served for close to 10 years, he was instrumental in building strong quality systems and was also a member of the Steering Committee of their Six Sigma initiative. Prior to this, Ganadish handled leadership roles in the Quality function at companies such as Sandoz Limited, Ranbaxy Laboratories in India and Ohm Labs in the USA.

He is a member of the International Society for Pharmaceutical Engineering (ISPE), the expert committee of Indian Pharmacopoeia, and the Quality Forum of the Indian Pharmaceutical Association (IPA).

Ganadhish holds a Master of Pharmacy degree from Mumbai University and a Diploma in Business Management from Goa University.
Name & Degree : Shivkumar Vishwanathan, B.E. (Chem), Dip Packaging Technology, Director and V.P. Marketing
Organization : GVS Cibatech Pvt Ltd
Title of Talk :












Biographical Information

Shivkumar Vishwanathan is a Chemical Engineer and a Packaging Technologist by training. He has close to 2 decades of experience in the Manufacturing, R&D, Audit and Laboratory testing and consulting. He has worked in Multinationals like Clariant, Bureau Veritas, Ciba, BASF and Intertek. For the last 8 years along with process risk assessment he has been involved in creating awareness in the Pharmaceutical Industry on Extractable & Leachables through several training programmes and lectures. He has been involved in more than 100 EL studies on various dosage forms including Injectibles, Ophthalmics, Transdermal patches, nasal sprays, Liquid Orals etc. He started his own testing and consulting facility – GVS Cibatech in 2015 and continues to provide his expertise in both testing and consulting on pharmaceutical packaging.
Name & Degree : Ajit Ganesh Datar, M.Sc, Ph.Dg
Organization : Shimadzu Analytical India Pvt. Ltd., Mumbai
Title of Talk :












Ajit Ganesh Datar is working as an Advisor to Shimadzu Analytical India Pvt. Ltd., Mumbai in the Customer Support Centre. His main job profile is to provide instrumental analysis support to the customers and provide training. Prior to Shimadzu, he was with Thermo Electron and served this organization as General Manager, Advanced Mass Spectrometry. He was responsible for promoting advanced Mass Spectrometry products of Thermo Finnigan in India. He retired in 2007 after completing 58 years. He served for Chromline and IR Technology as Technical Director and Sr. Manager respectively for period of 15 years. His first assignment was with Central research Station of Associated Cement Cos Ltd as Research Officer. He served ACC for 12 years. He has developed methods for characterization of catalysts and process products using catalysts. He indigenously developed BET Surface Area Analyser and particle size analyser.

Dr. Datar received his M.Sc. in 1971 and Ph.D. in 1976 from Mumbai University. He was recipient of Department of Atomic Energy Fellowship in 1971 and carried out his Ph.D. research from Analytical Chemistry Division of BARC.

He is currently also working as Adjunct Professor in Khalsa College and a visiting faculty at several other colleges in Mumbai. He has several publications in his name and is a guide for Ph.D. in Mumbai University.
Name & Degree : N.Subramanian ,M.Pharm., Ph.D
Organization : Mylan laboratories limited
Title of Talk : Head of Formulation Injectables - India












Biographical Information

Subramanian, Ph.D., has over Eighteen years’ experience in the pharmaceutical industry and has worked at various positions in Formulation development department. He has done his Ph.D in the field of Drug delivery systems. He has authored more than 10 international publications and has 4 patents to his credit.

Dr. Subramanian is currently working as Head of Formulations R&D for Injectables in India and he has a strong team of 80 + scientists working on various types of sterile dosage formulations. He has delivered various lectures on parenteral dosage forms in various national and international forums.
Name & Degree : Dr. Rajiv Desai
Organization : Lupin Limited
Title of Talk :












Dr Rajiv Desai, heads the Corporate Quality Management at Lupin Ltd.

Lupin Ltd is the ninth largest Pharmaceutical company in the world with manufacturing facilities located in India, USA, Japan, Brazil and Mexico.

Dr Rajiv Desai has around 30 years of experience in Pharmaceutical Industry. In his previous assignments, he has worked as head of Corporate Quality Management at Dr Reddys, Mylan, Piramal and Alembic Pharmaceuticals. He started his career with Ciba Geigy (now Novartis) in R&D and Technology transfers with assignments in India and Switzerland.

His experience in the Pharmaceutical Industry spreads across basic research, Technology transfers, Quality Management and Regulatory affairs.

He was a member of the US Pharmacopeia Expert committee between 2010 and 2015. He has been invited to deliver lectures at various international and national scientific forums. He has actively worked on several board of studies of reputed universities in India for short term teaching assignments and syllabus revision programs for post graduate courses. At UDCT, he was appointed as visiting faculty, under the Daiichi Karkaria memorial endowment faculty program for the year 2013 - 2014.

Dr Rajiv Desai, has a Ph.D from UDCT ( now ICT) in Pharmaceutical Chemistry and a post graduate degree in Management from NMIMS.
Name & Degree : Ms. Paramjeet Khandpur
Organization : Liquid chromatography, Agilent Technologies
Title of Talk :












Paramjeet Khandpur, M.Tech. received Bachelor’ degree in Chemical Engineering from VTU University and Masters under Dr. Parag Gogte in Bioprocess Technology from the Institute of Chemical technology, Mumbai. During her research tenure, she has published 6 research articles in several international journals.



Paramjeet is working as Application Scientist with Agilent Technologies India Pvt. Ltd. and is based in Bangalore. At Agilent, she has been working on liquid chromatography platforms like HPLC, UHPLC, 2D LC and preparative LC solutions. She is working in collaboration with several users in the Pharma industry for method development activities, HPLC to UHPLC method transfer, troubleshooting method related issues and has experience on various workflow of Pharma & Bio-Pharma markets. Prior to joining Agilent, she worked as a faculty at Biotechnology Department, VTU university, Karnataka.