Etienne Michel
Global QA for E&L
Etienne Michel, Global Quality Expert for GSK Vaccines
Etienne MICHEL currently holds the position of Global Quality Expert at GSK Vaccines, with an oversight on several expertise areas such as Extractable & Leachable, Cleaning, Bulk processes, Homogeneity and Chemical compatibility. Before that, in his role as Global Cleaning Expert, he has led the development and implementation of new cleaning strategies within GSK. Etienne is a Civil Chemistry Engineer with a master’s degree in environmental sciences and management from the Université Catholique de Louvain-la-Neuve in Belgium.
DAY 2: MARCH 8th, 2024
SESSION: Cumulative effect vs lego mode: how to simplify extractable approach
The goal will be to present how to manage the cumulative effect and to explain which simplifications can be implemented for extractable studies and patient exposure scenario:
◆ Why extractable studies are not always representatives?
◆ How to deal with cumulative effect described in regulations?
◆ The concept of Lego approach to simplify cumulative evaluation?
◆ How to use of digital tool to support approach and simplify patient exposure scenario and toxicological evaluation?
DAY 2: MARCH 10th, 2023
SESSION: How to implement USP 665 requirements before 2026
◆ Management of existing items, lifecycle and retrospective approach.
◆ Management of new items created between 2021 and 2026
◆ Ensure full compliance for items after 2026.
◆ Quid of Chinese pharmacopea?
DAY 2: MARCH 31st, 2022
SESSION: How to construct a quality risk assessment to define E&L requirements for sus in parenteral processes?
◆ Advantages / Risks of SUS.
◆ Balance between Fixed Equiment & SUS and regulatory evolution.
◆ Leachable Risk assessment: steps, methodology and associated testing requirements.
◆ Open discussion and conclusion on E&L requirements.
