A Best Practice Approach For a Compliant Annex 1 Biocide Qualification
Learn about the most important aspects of biocide qualification to minimize workload and comply with the regulator’s expectations.
Intermediate to expert
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Determining the efficacy of biocides is critical for maintaining the bioburden levels under control to have a safe, robust and reproducible pharmaceutical process.
However, qualification of biocides is a challenging process, which requires you to consider many parameters and regulatory requirements. Not doing it correctly may lead to contaminations and regulatory complications, which could lead to business shut-down.
This training will help you consider the most important steps in biocide qualification on the surface and accomplish the authorities’ expectations.
This will ease the work of the operators and SME to understand how the biocide will maintain the bioburden of the facility under control.
Completing this course will help you:
Who is the training for?
The webinar will be highly beneficial to anyone involved in a GMP aseptic production. That includes quality professionals, productions operators, validation experts, Contaminations Control Strategy SMEs, auditors and regulators.
About the speaker
Marc García Gómez
Marc is an expert on the qualification of disinfectants and sporicides and validation of cleaning and disinfection processes of Pharmaceutical Facilities. He is also the author of various articles in Spanish pharmaceutical magazines about cleaning and disinfection. Marc has performed training sessions in dozens of pharmaceutical manufacturing sites about personnel behaviour, hygiene and gowning, cleaning and disinfection of surfaces, Contamination Control Strategy and Risk Analysis following ICHQ9 principles.
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Up to 60 minutes private consultation meeting with our expert Marc García Gómez.
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