Rapid and Alternative Testing Methods – How to Implement quality and data integrity in a Modern Lab
The implementation of advanced microbiological methods should be part of continuous improvement in modern Pharma and Bio Pharma manufacturing. Most recent Global Regulatory updates and guidances are supporting the introduction and use of modern technologies. During this presentation an in-depth overview of the changes in requirements will be provided and an approach for the validation and successful implementation of these methods into routine QC will be shared.
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.