Missed our live webinar? No worries! You can now register to access the recording at your convenience. Dive into the essential components of a viable sampling program and discuss key elements that an organization should consider when developing its program.
EM challenges and benefits with the implementation of Annex 1
In this event, we will analyze the challenges and benefits of implementing a correct particle and microbiological monitoring plan and the analysis of the resulting data.
Abstract:
Annex 1 for sterile production underlines the importance of the absence of microbiological contamination in the finished product through the control and mitigation of microbiological, particulate and entotoxin risks during the production process.
This webinar focuses mainly on chapter 9 of annex 1 “Environmental and process monitoring” trying to analyze the challenges and benefits of implementing a correct particle and microbiological monitoring plan and the analysis of the resulting data.
Fill in the form below to register for on-demand access to the webinar. Once registered, you will receive a link and password to view the recording.
Our special guest: Gilberto Dalmaso
We are thrilled to announce that Gilberto Dalmaso, a key figure in the field of environmental monitoring, will be sharing his valuable insights and expertise with us.
What to expect?
The objectives of this webinar are to stimulate reflection on how to design a correct particle and microbiological monitoring plan and how to analyze the data that are generated.
Why join us?
- Interactive Sessions: We believe in two-way communication. Each webinar includes a Q&A segment, giving you the opportunity to ask questions and interact with experts.
- Free Access for All: Our mission is to spread knowledge. These webinars are open to everyone, from industry professionals to students and enthusiasts.
- Be a Part of a Learning Community: Join a network of like-minded individuals. Share your experiences, learn from others, and become a part of a community that’s shaping the future of environmental monitoring.
Who should attend:
This webinar is designed for professionals working in pharmaceutical manufacturing, quality assurance, quality control microbiology, sterility assurance, regulatory affairs, and anyone interested in staying informed about environmental monitoring trends in the pharma industry. If you’re passionate about advancements in contamination control, this webinar is a must-attend!
Reserve your spot today!
Don’t miss out on this opportunity to expand your knowledge and network. Sign up now and take your first step towards becoming a key player in the world of environmental monitoring!
Our special guest:
Gilberto Dalmaso
Gilberto Dalmaso has over 35 years’ experience in pharmaceutical microbiology and sterility assurance, primarily with GlaxoSmithKline (GSK) where he started in 1984 within Glaxo Verona (Italy). During his distinguished career he led a series of technology-driven process improvements using scientific methods, while achieving GMP compliance and regulatory approvals mainly for aseptic processes and sterile products.
Today Gilberto is the Global Pharma Advisor and Subject Matters Expert for GDM Pharma Consulting. In this role he collaborates and consults with global pharmaceutical companies to develop and implement science-based strategies and processes that utilize Quality by Design (QbD) principles to monitor, control, and improve the chemical, physical, and microbiological state of various production processes.
He’s also a qualified training for the most important regulatory agencies. With his extensive experience in sterility assurance and microbiology, Gilberto has the capability of supporting pharmaceutical manufacturers in a wide variety of aseptic processes, machinery, regulations interpretation and methods.
Hosted by:
Alexandra Bezilla
Having contributed significantly to industry leaders such as Lonza, Qiagen, Roosterbio, Emergent Biosolutions, and CBMG, Alex brings a blend of technical acumen with hands-on expertise. As a career QC scientist and growing compliance expert, she has consistently demonstrated a commitment to operational excellence and continuous improvement.
Alex holds an undergraduate degree in Biochemical Engineering from UMBC and a graduate degree in Biomedical Engineering from Clemson University. Beyond the laboratory, she brings a global perspective, having lived abroad in China, and is fluent in Mandarin Chinese. Alex also enjoys rock climbing and indulges in tabletop gaming.