Mayank Bhanti
Dr. Mayank Bhanti has been with USP since 2019 and holds the position of Senior Director in the Compendial Development Laboratory at USP India. He leads a team of scientists involved in the modernization of monographs for small molecules (drug substances and drug products), excipients, and food ingredients. Dr. Bhanti obtained his Ph.D. from […]
Dr. Archana Bahuguna
Dr. Archana Bahuguna is a Professional with a career spanning over two decades in Pharmaceutical companies – Unichem, Zydus Cadila, Merck KGaA, Pfizer, Accutest, KPMG, Raptakos Brett. She has extensive Global experience in leading Analytical R&D teams supporting development programmes (Phase 1 to Phase 3) for drug substances and drug products for diverse portfolios of […]
Andrew Teasdale
Former Chair of AstraZeneca impurities advisory group. Responsible for the development and oversight of policy relating to all impurity categories, including impurity qualification / genotoxic impurities / metals and extractables & leachables. Expert within the field of Genotoxic Impurities. Editor of the first book specifically focused on the subject matter : Genotoxic Impurities: Strategies for […]
Malcolm Rossi
Dr. Ross has over 35 years experience in the Generics Industry, the last 15 being at corporate level. He has been intimately involved in strategic planning, pipeline management and related activities. His early industrial experience with Teva and Taro were directed primarily to the US markets but later, as President of IPR, a company jointly […]
Lightening the nitrosamine load
Regulatory requirements for nitrosamine impurities are evolving, and the long-running issue continues to present pharma manufacturers with significant risk assessment, confirmatory testing and control strategy implications. As companies contend with the management of nitrosamine drug substance-related impurity (NDSRI) formation across a growing number of products, this session will cover:
Karen Capper
Karen is a pharmaceutical microbiologist with over 30 years’ experience in microbiology positions within the pharmaceutical industry. She has extensive knowledge in managing and operating QC microbiological and analytical laboratories as well as manufacturing experience in aseptic production. She has specialist knowledge in the microbiological assurance of aseptic processes, environmental control of non-sterile pharmaceuticals and […]
The Smart Lab Revolution:
Digitalisation and Automation for Enhanced QA/QC Efficiency and Reliability
