The topic will focus on the various aspects of study designs in order to perform for Medical device and Pharma product in a general view. The main focus will be on sample preparations, extraction techniques and quantifications approach in a systematic approach. This will enable to design the studies with scientific rationale. Also, I would like to discuss the aspects of dealing with Identification and classification of compounds observed in the E & L studies. The presentation is focused on approached to be followed while working with various categories of Identification level of compounds.

Presented by Divya Regulagedda, Manager, Global SME- Extractables & Leachables at Chemo

Divya Regulagedda is Manager in Chemo (part of Insud Pharma group), with 15+ years of experience in Pharmaceutical Analytical field including 12 years in the field of E & L for 11+ years. I have hands on experience with LC-MS/MS, LC-QTOF, GC-MS/MS, ICP-MS and IC. Her expertise includes analytical method development, laboratory investigation, study coordination, project leader and process improvement. Currently, she is responsible for the E & L work in Insud Pharma for Pharmaceutical products and medical devices and have worked with various dosage forms and evaluated the materials to be used in packaging

Followed by a live Question and Answer Session