Risk, Training and Data Integrity in EM Programs
Abstract:
In the dynamic field of environmental monitoring, ensuring robust and compliant systems is crucial. This December, we’re bringing together top industry experts to explore the essentials of effective EM programs, covering topics that bridge Risk Management, Training, and Data Integrity. In an interactive “fireside chat” format, our panelists will dive into best practices, challenges, and emerging trends to help you strengthen your EM protocols and drive compliance.
This session is not a lecture—it’s an engaging conversation with those who know the landscape best, and who can offer practical, field-tested insights.
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 guests:
We’re thrilled to welcome back our distinguished speakers who have led our past webinars:
- Vanessa Figueroa: Contamination control and sterility assurance expert with extensive experience in establishing Environmental Monitoring (EM) programs using a risk-based, lifecycle approach.
- Abby Roth: Specialist in Risk Management and Quality Assurance for sterile and non-sterile compounding.
- Gilberto Dalmaso: Renowned consultant in regulatory compliance and environmental monitoring standards.
Each expert will bring their unique perspective and extensive experience to this roundtable, providing you with actionable guidance.
What to expect?
This roundtable will be an engaging, interactive discussion with:
- Live Polling: Participate in real-time polls to share insights and learn about industry trends.
- Panel Discussion: Our panelists will tackle key topics around risk, training, and data integrity.
- Rapid-Fire Round: In the last 10 minutes, get answers to your most pressing questions in a fast-paced Q&A.
Key Topics:
- How do companies prepare to speak with inspectors about their EM program: differences between pharmacy compounding sites vs sterile drug manufacturers?
- How do I decide which EM samples to Identify beyond action and alert excursions (evaluating risk)?
- How do 503A compounding facilities compare to GMPs on EM data integrity and compliance expectations?
- Training considerations specific to EM programs, and how they differ between pharmacy compounding and sterile drug manufacturers.
Why join us?
- Gain Insights: Get practical advice directly from seasoned experts with proven track records in environmental monitoring.
- 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.

Vanessa Figueroa
Vanessa Figueroa leverages her combined knowledge of the Pharmaceutical, Biotechnology and Medical Decives industries to provide manufacturers across the US, Europe and India with critical laboratory operations management and personnel training programs to ensure compliance with cGMPs as well as global regulatory standards.
Combining hands-on Quality Control, Sterility, Inspection, and Compliant Operations with an educational leadership approach and natural business acumen, Vanessa brings 17+ years of real-time experience to deliver transformational real-world results.

Abby Roth
Abby Roth, founder of Pure Microbiology, has been supporting the testing and consulting needs of the pharmaceutical, medical device, and compounding industries since 2004. Her background in pharmaceutical microbiology includes extensive knowledge of environmental monitoring.
Abby served as a USP Compounding EC member during the 2015-2020 cycle.
She is an involved member of the Controlled Environment Testing Association (CETA), serving on the Board of Directors, speaking at its annual meetings, and chairing committees for the revision of five CETA Application Guides. Abby has been invited to speak for state boards of pharmacy and for national organizations.

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.

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.