Moderated by Shri Vinod Arora, Principal Advisor, IGMPI
Moderated by Shri Vinod Arora, Principal Advisor, IGMPI
Moderated by Shri Vinod Arora, Principal Advisor, IGMPI
GMP: A continous process
Fighting fakes with technology
Trends in lab design
Oral solid dosage forms: Trends and opportunities
Optimising FR&D to expedite regulatory complaince
By Shri Vinod Arora, Principal Advisor, IGMPI
Aligning Drug Safety and Regulatory Compliance with Argus Safety Software
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CHMR, IGMPI Faculty
She is associated with IGMPI as an Assistant Professor and prior to that, she has worked for more than 6 years with esteemed healthcare sector, Operation Head at a Cogito on USA based project related to Artificial Intelligence. She is an MPH (Masters in Public Health) from ICRI Himgiri Zee University Dehradun, and B.D.S from I.D.S.T Modi Nagar She brings a rich experience of nearly a decade in the areas of Patient Care, Quality Audits, Hospital Administration, Quality Management, Accreditation Programmes with ability to lead, supervise and manage. Moreover, she has also been associated with various renowned organisations like Scale NGO, Drona NGO and Dabur Lal Tooth Paste & Amar Ujjala as Programme Coordinator. Additionally, Dr Richa has also worked as Dentist in various hospitals for their accreditation programmes of multiple hospitals. Over the years, she worked on Ayushman Bharat Project as Claims Manager & Apollo Munich healthcare at the highest standards so that the patients receive the highest level of healthcare. She ensures Quality Assurance and Compliance functions. She also monitors different Health Policies, expenses and suggest cost-effective alternatives along with creating and reviewing multiple documents of organization including SOPs, Manuals, Protocols,and annual budgets. She has been involved closely in conducting and lead quality audits, drills, awareness, and training programmes. She also leads the periodical assessment of health Policies on quality check list, Identifying the gaps and developing action plan.
She is associated with IGMPI as an Associate Professor and prior to that, she has worked for more than 5 years with esteemed healthcare sector, Shri Ram Singh Hospital & Heart Institute and Ashok Multispeciality Hospital as a Quality Head and NABH Consultant. She is an MBA in Health and Hospital Administration from Jamia Hamdard University and BUMS from Delhi University. She brings a rich experienceof nearly a decade in the areas of Patient Care, Quality Audits, Hospital Administration, Quality Management, Accreditation Programmes with ability to lead, supervise and manage. Moreover, she has also been associated with various renowned organisations like Fortis and Metro Group of Hospital as a Senior Quality Coordinator. Additionally, Dr Saniya has also worked as a RMO in various hospitals for their accreditation programmes of multiple hospitals. Over the years, she designs and implements Hospital policies& programs at the highest standards so that the patients receive the highest level of care. She ensures Quality Assurance and Compliance functions. She also monitors expenses and suggest cost-effective alternatives along with creating and reviewing multiple documents of organization including SOPs, Manuals, Protocols,and annual budgets. She has been involved closely in conducting and lead quality audits, drills, awareness, and training programmes. She also leads the periodical assessment of hospitals on quality check list, Identifying the gaps and developing action plan
Ms. Megha Bhardwaj is working as an Associate Professor in IGMPI. She has completed her Masters in Clinical Research from Cranfield University, Bedford, U.K. She also has a certified 1 year PG Diploma in Clinical Research Management. She has 8 years of experience in Clinical Research Industry. She has worked as a Clinical Research faculty with Jims College. She has also worked with Medanta The Medicity Hospital (In Liver Transplant Department, Kidney Dept.). She had also worked with Panacea Biotech and Bristol Mayer’s Squibb. She is a proficient professional with expertise in Clinical trials. She has faced a Global Audit for her Project “CRAD001H2307 Site 4001, Novartis Phase III Drug Trial”. She has immense experience in Clinical Trial Projects that include Sponsor initiated: A 24 month, randomized, controlled study to evaluate the efficacy and safety of concentration-controlled everolimus plus reduced tacrolimus compared to standard tacrolimus in recipients of living donor liver transplants”. Sponsor initiated peritoneal dialysis outcomes, Incidence of graft rejection and risk associated in Patients undergoing Liver Transplantation, Global: Medical Device versus Standard of Care Drug Therapy in patients with Chronic Hepatitis C infection, Prospective, Open label study comparing enteric-coated mycophenolate sodium (EC-MPS) with Mycophenolate mofetil (MMF) with calcineurin inhibitor (CNI) de-novo in patients after primary liver transplant and Acute Kidney Injury. At IGMPI, her responsibilities include teaching, training and guiding of students over subjects of Clinical Research, QA&QC, Regulatory Affairs, and Pharmacovigilance.
Ms. Ria Banerjee is an Assistant Professor at IGMPI and has more than five years of total teaching experience in the Pharmaceutical Department. She has completed her B.Pharm from Annamalai University, Chidambaram, Tamil Nadu in the year 2013 and secured second position with a silver medal at her Department. She then completed her M.Pharm (Pharmaceutics) from Uttarakhand Technical University in the year 2015. She has worked as project trainee at CSIR-CDRI where she formulated “ Dual Acting Ciprofloxacin HCl and Calcium Phosphate Nanoparticles for therapeutic intervention of Osteomyelitis”. She specializes and possesses knowledge about various drug formulation and their characterization. She has hands on experience in Formulation and Development of Nanoparticles and Nanoparticles embedded drug dosage forms. She has keen interests in developing Novel Drug Delivery Systems and has attended various national and international conferences regarding NDDS. Her research interests include Formulation development and evaluation. She demonstrates a plethora of knowledge in the area of Novel drug delivery systems, Nanoparticulate drug delivery and targeted drug delivery systems. She has also worked in the IPR and drug regulatory sector where she monitored and analyzed new patent publications and their abstractions and annotations. She has worked with the pioneer organization like Thomson Reuters now Clarivate Analytics in Science and IP department. She aims to utilize her insights on research skills, formulation skills, analytical skills, regulatory knowledge, IPR and management skills about pharmaceuticals and cosmetic formulations to impart knowledge to students which contributes to their professional development.
At IGMPI, her responsibilities include teaching, training and guiding students over subjects of Pharmaceutical formulations, IPR and Cosmetic technology.
Ms. Priti Maurya is associated with IGMPI as an Associate Professor. She has completed her Masters in Biotechnology from MIMT,Grt.noida. She is competent professionally having 10 years of enriching experience in Quality Assurance, compliances GMP and Bio analysis. She has talent for proactively identifying & resolving problems and maintaining quality standards at the same time.Excellent communication & interpersonal skills with strong analytical, team building and Strong leadership organizational abilities.
She has worked with APCER Life Sciences as Assistant Manager in Training and Auditing department. Implemented quality procedures in the organization to reduce rejections and ensure zero defects as per guidelines. Ensure compliance and up gradation of Quality system in company so that there are no critical issues during audits of external regulations. She has also workedwith Parabolic Drugs Ltd asSenior Executive Quality Assurance. Handled and Implemented TQM, QRM, deviation, OOS & change control, Co-ordinate with production to address CAPA for deviation and closure of change controls. Prepared Annual Product Reviews report and Management Quality Review report, Quality Policies, Quality Manual.She has also worked with Panacea Biotech Ltd as Executive R&D. AnalysedIgG (Pn PS ELISA),IgG antibodies against Bordetella pertussis, Diptheria, Tetanus, Haemophilus influenza, Hepatitis in human serum, Hemagglutination inhibition assay (HAI).Analysed drugs using analytical techniques like HPLC/UPLC, NMR, LC-MS, FTIR, Flow Cytometer, Polarimeter, UV Spectrophotometer etc. She has got notable credits in audit conducted by FDA, MHRA, WHO, Customer Visits.
Conducted training and seminar on Topics: Manufacturing Process improvement in the pharma and Healthcare industry, Implementing Good documentation practice in organization, Approach toward Zero defects, Principle and working procedure of Basic Techniques and Instrumentation in Biotechnology, Phytopharmacological and pharmagonistical study of Nyctanthus –arbor tristis leaf for the treatment of arthritis.
At IGMPI, her responsibilities include teaching, training and guiding students over subjects of GMP, QA&QC, and Cosmetic technology.
Syeda Alisha Md Isha Ali is an Assistant Professor at IGMPI. She has completed her B.Pharm from Savitribai Phule Pune University in 2014 and M.Pharm (Pharmaceutical Quality Assurance) from Manipal University, Manipal in 2016. She has prior industrial experience in product development and evaluation in Apotex Research Private Limited, where she was involved in conducting stability studies of pharmaceutical oral solid dosage forms. She specializes and possesses knowledge about routine stability studies, quality assurance and regulations in GMP for ANDA, ANDS, MHRA, and TGA authorizations as per ICH. She is currently submitting her doctoral studies, Ph.D (Pharmaceutical Sciences) at Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal. Her credentials include three Scopus-indexed publications in good impact journals in areas of stability studies of pharmaceutical products and Ayurvedic formulations. She has represented her doctoral studies in various international and national conferences. Her research interests includes product development and evaluation, quality assurance and control strategies, stability studies as per ICH, developing scientific evidence for the stability of pharmaceutical and Ayurvedic formulations using modern analytical techniques. With her diverse involvement in Pharmaceutical and herbal domain, she demonstrates a plethora of knowledge in quality assurance, quality control, drug discovery and product development and regulatory aspects on Pharmaceuticals and herbals. She aims to utilize her insights on research skills, analytic skills, writing skills, regulatory knowledge, GMP, GLP, GDP, data integrity, quality assurance and management skills about pharmaceuticals and herbals to impart knowledge to students which contributes to their professional development.
Publications include:
Dr. Neha Ronald William is an Associate Professor at IGMPI. She has completed her B.Pharm from Kurukshetra University in 2010 and M.Pharm (Pharmacology) from Pt. B.D. Sharma University, Rohtak in 2012. She earned her PhD (Pharmaceutical Sciences) from Sam Higginbottom University of Agriculture, Technology and Sciences (SHUATS), Allahabad (Uttar Pradesh) in 2020. Her credentials include 8 publications in various journals of repute with high impact factor (Thomas Reuters) and one book published in lambert academy on memory enhancing activity on Fluvoxamine maleate. She has also represented project in DST. She has 9 years of experience in teaching and research. Her research interests include Alzheimer disease, cancer, Neurodisorders. With her rich involvement with the Pharma area, at IGMPI she contributes her insight and wide experience of the business to prepare and direct the students for the better methodology in the profession way and to take their ability advancement and information to the following step. Under her direction and management students can unquestionably take their vocation forward.
Book Published:
Papers Published:
Ms. Deepti Makhija is an Assistant Professor at IGMPI. She has completed her M.Pharm from Manipal University. She has sound experience in research and development in formulation of oral Solid Dosage form, Semi-Solid dosage form and Parentral formulations. She is the spectator of “International Seminar on “Innovation and Entrepreneural Opportunities in Nanotechnology”, 10th knowledge Millenium summit inaugurated by the honourable President of India on ‘Curing the incurables : sharing of innovations ‘ at Department of Biotechnology, Ministry of Science and technology, Government of India, CSIR sponsored National Seminar on IPR in Pharmacy: Patent Drafting & filling, AICTE sponsored seminar on Design of Experiments and Speaker of the Interactive Session of Pharmaquora, ICMR sponsored National seminar on Advanced Pharmaceutical Technology and dosage form- Where does India stand in global Context. She had been associated with various Pharma giants which include Ranbaxy Laboratories, Jubilant Generics Ltd., Lupin Pharmaceuticals, Kusum Healthcare and Mankind Research Centre. At IGMPI, she contributes her knowledge and wide experience to guide the students to pick their path for the better approach in their upcoming career from the industry related to Pharma, healthcare; Pharmaceutical Packaging, Pharmaceutical Technology Transfer, Pharma Product Management, Pharmaceutical Formulation and Entrepreneurship, Pharmaceutical Sales and Marketing Management, Pharmaceutical Process Engineering and Cosmetic Technology.
Ms. Priyanka Rautela is working as Assistant Professor at IGMPI. She has experience of more than six years in Sales & Marketing and Pharma Industry, she holds a Master’s Degree in Pharmacy (Pharmacology). She has worked in sales for with Cipla and has rich experience as a Product Specialist. Her main forte is training with good interpersonal skills, she has prepared strategies for various brands pan India, has an experience in new product launch with sound knowledge on data analysis, Brand planning, visual aid designing. She also carries an experience of Digital marketing, social media marketing, email marketing . In IGMPI, she is contributing as a faculty of Pharma Product Management, Pharmaceutical Sales and Marketing Management.
Mr. Vinod Kumar Arora is an internationally acclaimed industry professional having 35 years of rich experience in pharmaceutical development in the areas of Generics, Differentiated, NDDS/NCE Dosage Forms. He is now associated with IGMPI as principal advisor.
He joined Ranbaxy in 1983 where he initially worked as scientist for almost 4 years. He rejoined Ranbaxy in 1994 where graduated to Vice President level from Assistant Director position. During his association with Ranbaxy he developed products - Generics, Differentiated Generics, NDAs and NCE-Global, market specific and OTC. Prior to his association with Ranbaxy, he worked as an Assistant General Manager with the Formulation Development Research in Cadila Laboratories, Ahmedabad and helped in setting up of Onco-manufacturing facility and developed several oncology products. He has expertise in Dosage Form development in the area of dosage forms - Solids - Tablets / Capsules / Granules / Pellets / PFOS / TFOS; Non-solids-Liquid/Injectables including Lyophilised/Topicals, Inhalations - DPI/pMDI and Nasal Spray, Dosage Forms Technology such as Nanotechnology, Depot Injection; Modified Release tablets/suspension, Self-Emulsifying System, Oro dispersing tablets/oro-dissolving strips; Particles/Pellets coating and has good understanding of current Good Manufacturing Practices and QA/QC. He has made presentations to NDAC Committee for New Drugs Approval in India, had meetings with Oman MOH and Pre IND meetings with USFDA. He has also authored/co-authored over 100 patents in the area of NCE/ Differentiated products /NDDS/Generics. With his knowledge and rich experience, he is focused on practical aspects of current needs, contemporary and emerging trends, besides alerting the pharmaceutical industries for future challenges. He is holding many honorary positions - Present Member of Indian Pharmacopoeia Commission (IPC) Scientific Body, Consultant to Central Drugs Standard Control Organization (CDSCO), Panel member of INMAS-DRDO, Ranbaxy Science Foundation Scholars Award, Global Expert committee member of DFE Pharma, Germany and Distinguished Scientist from World Whos Who Society, Member of Indian Pharma Committee of Make in India Campaign etc. He was felicitated by Honble former President of India Dr A P J Abdul Kalam, for development and launch of first NCE - Anti malarial from India. Mr. Vinod Arora is a M. Pharm degree holder from BHU and DBM from IMM, New Delhi. As one of our principal advisors he is continuously supporting our initiatives nationally and internationally to rest of faculty members of IGMPI in imparting education, training and continuing education programs as well as our knowledge dissemination initiatives like Current GMP,QA/QC, Regulatory affairs,Clinical research guidelines and news updates.
Dr. Mahesh C Gupta is an experienced and internationally reputed Scientist in the field of calibration, quality assurance and testing. He has last worked with National Physical Laboratory (NPLI), New Delhi for 32 years where he played a vital role in developing the lab accreditation program of India as Head National Calibration Program. He is also the founder president of Indian quality association. He has expertise and proficiency in various fields like calibration, GLP, analytical techniques, quality assurance, laboratory inter-comparison, proficiency testing, QMS and many more. With his knowledge and rich experience, he is focused on practical aspects of current needs, contemporary and emerging trends, besides alerting the laboratories for future challenges. A PhD from Indian Institute of Technology (IIT), New Delhi, Dr. Mahesh C Gupta has been associated as a research fellow of Optical Society of India, Fellow of Indian Society of Lighting Engineers and Vacuum society of India. He has also worked with Dubai Central Laboratory, Dubai as Principal Quality Officer. He is also currently managing Lab World Magazine- renowned world class magazine dedicated to Quality Testing and Calibration laboratories in all sectors-as the Editor in Chief.
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