Challenges in Analytical Method Transfer

About the Webinar
The webinar provides brief outline of analytical method transfer activity and signifies its role in product life cycle management. It covers information on available regulatory as well as other important guidances. It further discusses different types of analytical method transfer approaches and challenges associated with them. The most common approach, “comparative testing” has been emphasised and discussed by means of sufficient statistical examples. This will help in selecting appropriate statistical approach when performing comparative testing. It also covers elements of a successful method transfer like well-designed protocol, training etc. The presentation concludes with discussing common challenges of an effective method transfer.
About Mrunal Atul Jaywant, Ph. D., PGDMM,
Dr. Mrunal is a Senior Director - R&D at USP India. She is overseeing Compendial Development Laboratory, Isolation and Characterization Laboratory and Documentary Standard Division (Science) at USP India. The main responsibilities are to support Development of Documentary standards (such as Monographs for Drug substance, Drug products, Excipients and Food) and Reference standards. Dr. Mrunal has over 24 years of Pharmaceutical Industrial experience that includes 4.5 years of association with USP India. She has successfully led Analytical Research and Development Department at various capacities in Indian as well as Multi-National Organizations and contributed in Development, Validation and Transfer of Stability Indicating Analytical Methods for Drug Substances and Drug Products. She has also been actively involved in Estimation of Potential Genotoxic Impurities by LC-MS/MS, GC-MS/MS etc.
Dr. Mrunal has been conferred with prestigious ‘Prof. Dr. R. T. Sane - Outstanding Pharmaceutical Analyst Award’ at 20th IDMA-APA Pharmaceutical Analysts Convention (PAC) 2018 on May 18, 2018.