USP 621 Decoded
USP <621> is a crucial chapter in the USP guidelines, affecting around 5000 monographs. It emphasizes the importance of establishing meaningful system suitability criteria for chromatography procedures to ensure valid, compendial, and regulatory compliance. The latest version of USP <621>, effective from December 2022, provides detailed guidance on method adjustments and transfers, facilitating the modernization of existing USP monograph methods. The revisions also expand the scope for modifying gradient method parameters and allow the transition from totally porous silica-based analytical columns to superficially porous particle-based columns to better meet industry needs.
Key Learnings:
- Strategies for optimizing chromatographic performance using right HPLC system
- Understand the latest updates in USP <621> and how they impact chromatographic practices
- Techniques for enhancing laboratory productivity and reducing operational costs
- Strategies to modernize chromatographic conditions with case-studies
- Revised System suitability requirements and allowable chromatographic system adjustments
- and more
Presenter: Dr. Manoj Kumar Singh (Senior Vice President, Microlabs Analytical Research Lab)
Dr. Manoj K Singh hold over 30 yrs of professional experience of working with global pharma companies leading their Analytical labs to support different pharma work-flows.
He holds a Ph.D. degree (Chemistry).
He started his professional career in 1993 with Wockhardt and spent significant tenure at major pharma R&Ds like Lupin, Novartis, Orchid, Dabur & Sentiss Pharma.
Currently he is associated with MicroLabs Bangalore as Senior Vice President (ADL) leading team of Analytical Chemistry scientists to support formulation development, Validations and method transfer.
Presenter: Dr. Kuldeep Sharma (Sales Development Manager - Pharma, Agilent Technologies)
Kuldeep Sharma has over 19 years of experience in area/s of Bioanalytical research, Drug metabolism & pharmacokinetics and Pharma regulatory compliance. He has accomplished PhD in Biotechnology. His professional journey covers over 12 years in Analytical research (associated with R&D’s of Zydus Cadila, Lambda, Pliva and Jubilant Biosys) and last 7 years in analytical instruments sales, marketing & business development. With over 21 research articles published in international Journals, He presents convention of continues learning.
