Presenter at Tema Renrum 2025

Read more about Michel’s presentation below

Michel Domingues

Ecolab Life Sciences

Michel is a microbiologist with over 15 years of experience in water, food and pharmaceutical sectors.

He has in depth knowledge of quality systems, microbiological contamination control and risk management, and extensive experience in regulatory compliance.

Michel is IRCA qualified.

 

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With over 15 years of experience in microbiology across the water, food and pharmaceutical sectors, Michel is a seasoned pharmaceutical microbiologist specializing in Quality Control (QC) and Quality Assurance (QA).
 
Throughout his career, Michel has been committed to improving processes, fostering organizational development, and implementing advanced technologies. His expertise includes driving operational excellence, maintaining strict quality standards and leading continuous improvement initiatives. Michel is experienced in GMP requirements, bioburden testing, environmental monitoring, endotoxin testing,
microbiological method validation, and microbial identification. His career has focused heavily on regulatory compliance, including harmonized pharmacopeia method validation, initiatives to meet evolving regulations and managing Quality
Management Systems.
 
Before joining Ecolab, Michel worked for several years as the manager of the microbiology laboratory and quality assurance manager for the drug product
department at a multinational pharmaceutical company.
 
In his past roles, he led a team of analysts and several technical expert teams responsible for routine operations, microbiological analysis of raw materials,
finished products and water systems. He also provided training in aseptic practices and ensured the quality assurance of processes and procedures from batch
manufacturing to batch release. Michel has driven innovation by implementing automated and rapid microbiology techniques and electronic notebooks
throughout his career.
 
Michel joined Ecolab as a Senior Global Technical Consultant in 2024 and is based in Portugal. In this role, he is responsible for providing support and guidance on contamination control best practices in a GMP environment, ensuring compliance with current regulatory expectations and industry standards.
Presentation:

The importance of detecting and effectively removing disinfectant residues in the GMP environment

EudraLex Vol.4 Annex 1 (August 2022) resulted in an increased regulatory focus on the residues associated with cleaning and disinfection agents.

This presentation highlights the importance of detecting, proactively controlling and removing residues, as well as the visual and chemical impact of residues if not effectively removed. Michel will present their published analytical methodology, to give the audience guidance on how to quantify disinfectant residues in situ and demonstrate the effectiveness of the removal techniques employed at a facility level.

The audience should go away with a framework on how to perform this analysis themselves, retrospectively for their existing regimes or as part of performance qualification.

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