A Best Practice Approach For a Compliant Annex 1 Biocide Qualification
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Determining the efficacy of biocides is critical for maintaining the bioburden levels under control to have a safe, robust, reproducible pharmaceutical process.
However, qualification for biocides is challenging, requiring you to consider many parameters and regulatory requirements. Not doing it correctly may lead to contamination and regulatory complications, which could lead to the shutting down of business.
This training will help you consider the essential steps in biocide qualification on the surface and accomplish the authorities’ expectations.
It will ease the work of the operators and SMEs to understand how the biocide will maintain the bioburden of the facility under control.
COMPLETING THIS COURSE WILL HELP YOU:
- Optimize biocide qualification workload and time consumption. Prevent typical mistakes or misunderstandings.
- Avoid possible contamination on surfaces that could affect the safety and efficacy of the pharmaceutical product.
- Avert safety problems for the patients.
- Minimize batches rejection.
- Avoid observations/warnings from the authorities.
- Comprehension of bacterial spores.
- Determine biocide efficacy on all microorganisms range.
Who Should Attend:
The webinar will benefit anyone involved in a GMP aseptic production. That includes quality professionals, production operators, validation experts, Contaminations Control Strategy SMEs, auditors, and regulators.
- Skill Level: Intermediate , Expert
- Critical Concepts
- What New Annex 1 Will/Could Proclaim About Biocide Qualification?
- Under What Premises a Biocide Qualification Should Be Done?
- Factors To Consider Before Starting A Qualification In A Laboratory
- Once All Qualifications Are Done, What Could Be Wrong with Applying The Biocides On Surfaces?
- Example Of An FDA Warning Letter
Marc García GómezEU QA Associate / Consultant of pharmaceutical contamination control strategy
Marc is an expert on the qualification of disinfectants and sporicides and validation of cleaning and disinfection processes of Pharmaceutical Facilities. Marc is 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 behavior, hygiene and gowning, cleaning and disinfection of surfaces, Contamination Control Strategy and Risk Analysis following ICHQ9 principles.
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