Extractables & Leachables Studies For Pharma & Medical Device Companies
Listen to our expert’s share their insights on Compliance with USP <665> and USP <1665> Guidelines and Chemical Characterization for Medical Devices
Ensure the safety and compliance of your pharmaceutical and medical device products with our in-depth webinar on Extractables & Leachables (E&L) studies. Our expert speakers will guide you through the critical aspects of chemical characterization and regulatory compliance, specifically focusing on USP<665> and USP<1665> guidelines. Understanding and implementing robust chemical characterization strategies is crucial for meeting stringent regulatory requirements, particularly those outlined in ISO 10993:18 &12
In this webinar, you will learn –
- Master USP compliance – understand the nuances of these critical guidelines and how to implement them effectively
- Practical tips for achieving regulatory compliance and minimizing delays
- The importance of chemical characterization in medical device development
- A comprehensive overview of ISO 10993:18 &12 requirements
- Strategies for designing effective chemical characterization studies for medical devices
Speakers
Vudathu Trinadh
Vudathu Trinadh Senior Manager Analytical ServicesEurofins BioPharma Product Testing, IndiaTrinadh brings extensive analytical chemistry expertise, holding a master’s degree. He has been working with Eurofins Biopharma Product Testing India since October 2023, where he has led the Extractables & Leachables (E&L) section, specializing in packaging materials and medical devices. With seven years of experience exclusive in E&L studies and 18 years of experience in characterization, development, validation and transfer for drug substances and drug products, he empowers global drug manufacturers to achieve regulatory compliance, particularly in E&L testing.
Simone Carrara
Business Unit Manager, E&L TestingEurofins Biopharma Product Testing, ItalySimone joined Eurofins BioPharma Product Testing Italy in 2012. he is the Business Unit Manager of the Extractables & Leachables and packaging testing department. He is also E&L Senior Scientific Director in eurofins. Starting from a biotechnology degree at the University of Milan in 2005, he built his experience as a bio-analytical researcher through LC/MS method developing for Pharmacokinetics analysis and ADMET profiling. He has led projects in a wide range of areas of the analytical chemistry including method developing/validation by LC/MS-GC/MS and drug product impurities characterisation. In the last 10 years his job was focused on Extractables & Leachables testing to support drug-manufacturing companies in the fulfillment of the regulatory requirements.