Efficiently monitoring microbial contamination in the cleanroom has become even more crucial over the recent years, specifically with the impending release of EU GMP Annex 1.
Modern pharmaceutical manufacturers are already generating and managing big data from environmental monitoring; the next step is to create actionable insights and ensure 21CFR11 compliance. This webinar discusses data collection, 21CFR11 data management and the generation of actionable insights.
On 26 February, we will review how this is accomplished by leveraging industry standards such as the FDA / ICH guidelines that encourage the use of control charts as statistical tools to guarantee that a manufacturing process remains in a state of control (the validated state).
Attend this webinar to learn:
- Critical microbial data management – Interpretations, considerations and solutions for data integrity, statistical control and FDA guidelines.
- FDA and ICH guidelines and recommendations – How to leverage this information for better contamination control.
- Data integrity – Definition and Inspectors’ perspective regarding environmental monitoring and data management, with attention to 21CFR Part 11.
- Elements to consider to ensure that a process is under statistical control.
- The future of microbial monitoring in the Pharma industry – Benefits of single use microbial monitoring.
Paola Lazzeri and Giulia Artalli will be presenting the webinar.
Paola is currently part of the EMEA Sterility Assurance / Microbiology Product Specialist Team and the Advisory Team in Particle Measuring Systems. She is a subject matter expert in the field of cleaning and sanitization of Pharmaceutical Cleanrooms through constant dialogue with operators, quality officers, and financial and production teams.
She has experience in examining and understanding contamination issues with a specific focus on microbiological hazard, setting rational cleaning and sanitization of cleanroom and pharmaceutical manufacturing plants with relative drafting of VMP, and supporting pharma companies in the validation of sanitizing and decontaminating agents. Paola participates as a speaker at national and international conferences.
Dr Artalli has a degree in biology from the University of Milan with over 20 years’ experience in Microbiology, specifically for pharmaceutical applications.
Dr Artalli has covered different roles acquiring knowledge on different topics useful for supporting customers in their needs; she is a Global Product Line Manager at Particle Manager Systems for the Microbiology product line.
This presentation is offered at multiple times to suit various time zones. To find out the session that is best for you, please fill out the enquiry form attached to this page.