Jason Creasey
Managing Director
Jason Creasey is a graduate analytical chemist. In 2019, he established Maven E&L Ltd, as its Manging Director and Principal Consultant. Maven E&L was setup to provide advice to clients working in the pharmaceutical industry on all aspects relating to the topic of extractables and leachables (E&L) and the risks that leachables pose to the quality and safety of drug products. Prior to this, he worked for GSK where he was the director of their R&D E&L Team.
He has worked in the topic area of E&L since the mid 1990’s on a wide range of modalities and dose forms seeing this area expand and grow in significance for the pharmaceutical and medical device industries. In addition to running his consultancy, he is a scientific advisor to the ELSIE consortium. Since setting up Maven E&L; he continues to present, discuss, and write about E&L. He now publishes a regular E&L blog through LinkedIn and his Website (www.MavenEandL.com), for the exchange of ideas and discussion.
As well as supporting client projects, among recent E&L activity, he is presenting and commenting on risk- based approaches to E&L requirements within the pharmaceutical industry that he hopes will form part of an ICH guidance in the not-too-distant future and has helped ELSIE publish and discuss their whitepapers linked to Concepts in Leachable Risk Management and develop their database further.
DAY 2: MARCH 8th, 2024
SESSION: Leachable risk assessment approaches: a comparison of USP , biophorum, and other methods for assessing leachable risk in biopharmaceutical manufacturing systems
◆ There is no agreed format for leachable risk assessment.
◆ Both USP and Biophorum have published guidance.
◆ Presented is an alternative approach that might be considered, covering both severity and probability of leachable risk.
