Rapid Sterility Test A challenge or an opportunity to increase Quality within Pharma QC
About the Webinar
The implementation of Rapid Microbiological Methods has been supported by regulators for many years. Meanwhile, it is a common expectation that appropriate technologies are used to increase the safety and the quality of pharmaceutical drug products.
The webinar will cover:
• Relevant guidelines and validation parameters
• A successful approach for the validation of an ATP Bioluminescence based Rapid Microbial Method
• A well-defined method of stressing microorganisms to investigate a “worst case approach”
About the Presenter -Dr. Lucia Ceresa
Dr. Ceresa is a Senior European Technology Manager at Charles River Microbial Solutions. She is also a Vice President at present of PDA Italy Chapter, being member of PDA since 2005, and part of the Steering Committee since 2009. Graduated at the University of Milan on 1981 and specialized on Microbiology, Dr. Lucia Ceresa has an extensive international experience.
After 10 years of Permanent Qualified Teacher on Chemistry and microbiology, she started her career within the Life Sciences Industry at Millipore Corp., Gelman Sciences Corp, Pall Corp. and Particle Measuring Systems. Her expertise includes pharmaceutical aseptic production and all aspects of validation and quality control, particularly focus on GMP’s and of Alternative Microbiological Methods.
Видео Rapid Sterility Test A challenge or an opportunity to increase Quality within Pharma QC канала Pharma Best Practices Webinars
The implementation of Rapid Microbiological Methods has been supported by regulators for many years. Meanwhile, it is a common expectation that appropriate technologies are used to increase the safety and the quality of pharmaceutical drug products.
The webinar will cover:
• Relevant guidelines and validation parameters
• A successful approach for the validation of an ATP Bioluminescence based Rapid Microbial Method
• A well-defined method of stressing microorganisms to investigate a “worst case approach”
About the Presenter -Dr. Lucia Ceresa
Dr. Ceresa is a Senior European Technology Manager at Charles River Microbial Solutions. She is also a Vice President at present of PDA Italy Chapter, being member of PDA since 2005, and part of the Steering Committee since 2009. Graduated at the University of Milan on 1981 and specialized on Microbiology, Dr. Lucia Ceresa has an extensive international experience.
After 10 years of Permanent Qualified Teacher on Chemistry and microbiology, she started her career within the Life Sciences Industry at Millipore Corp., Gelman Sciences Corp, Pall Corp. and Particle Measuring Systems. Her expertise includes pharmaceutical aseptic production and all aspects of validation and quality control, particularly focus on GMP’s and of Alternative Microbiological Methods.
Видео Rapid Sterility Test A challenge or an opportunity to increase Quality within Pharma QC канала Pharma Best Practices Webinars
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23 июля 2020 г. 18:41:30
01:24:30
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