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What stayed with us from a year of Environmental Monitoring

If we had to describe 2025 in a single line, it wouldn’t revolve around a milestone or a headline event. It would be about the small moments; the ones

scientific thinking in QC microbiology

Rediscovering the Microbiologist’s Mindset in a regulated world

Why today’s QC laboratories need both scientific intuition and regulatory discipline In many GMP environments, daily microbiology work has gradually n

Project Manager and Technical Specialist at SherpaPharma |  + posts

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.

Seeing beyond limits: uncovering new insights in Environmental Monitoring data

Environmental Monitoring data hold far more insight than what’s visible through traditional alert and action trending. For decades, cleanroom programs

Project Manager and Technical Specialist at SherpaPharma |  + posts

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.

Curiosity, Legacy, and Practical Wisdom at PMF 2025

It was late, 10:30 p.m., when I finally stepped out of the muggy Tampa night and into the hotel lobby. I had just got in from a delayed and turbulent

Digital tools don’t fix culture but they can reveal it!

Intro: The myth of the digital fix In the world of pharmaceutical operations, there’s a persistent belief that software will fix broken systems. Compa

Project Manager and Technical Specialist at SherpaPharma |  + posts

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.

From innovation to compliance: New technologies and Data Integrity in Microbiology

Environmental monitoring in the pharmaceutical industry is a critical component in ensuring the safety, quality, and efficacy of pharmaceutical produc

Owner and Senior Advisor at GDM Pharma Consulting |  + posts

Gilberto Dalmaso has over 35 years’ experience in pharmaceutical microbiology and sterility assurance. 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.

Optimizing Environmental Monitoring in sterile compounding: Best practices and insights

Environmental monitoring (EM) is an integral part of ensuring sterile compounding and aseptic manufacturing environments remain compliant and contamin

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.

Key strategies for optimizing Environmental Monitoring Programs

This webinar featured an engaging discussion among industry experts, including contributions from my esteemed colleagues Gilberto Dallas, Abby Roth an

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.

SherpaPharma: 2024 milestones and developments

As 2024 comes to a close, we reflect on a year filled with progress, collaboration, and growth at SherpaPharma. From significant software developments

Q&A Summary on Environmental Monitoring and EU Annex 1

At the end of the webinar on environmental monitoring and the EU Annex 1, a series of key questions were addressed regarding the practical implementat

Owner and Senior Advisor at GDM Pharma Consulting |  + posts

Gilberto Dalmaso has over 35 years’ experience in pharmaceutical microbiology and sterility assurance. 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.

Project Manager and Technical Specialist at SherpaPharma |  + posts

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.

Environmental Monitoring and EU Annex 1 Implications: Key Insights

In a recent webinar, Gilberto Dalmaso, a pharmaceutical microbiology expert with 35 years of experience, discussed key implications of the EU Annex 1

Owner and Senior Advisor at GDM Pharma Consulting |  + posts

Gilberto Dalmaso has over 35 years’ experience in pharmaceutical microbiology and sterility assurance. 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.

Mitigating human error in Environmental Monitoring Investigations

Poster: Mitigating human error in Environmental Monitoring Investigations

At the PDA Micro conference, our team presented a critical analysis on the role of human error in Environmental Monitoring (EM) and how modern digital

Project Manager and Technical Specialist at SherpaPharma |  + posts

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.

Independent Consultant at Quality Executive Partners, Inc. (QxP) |  + posts

Sarah Boynton is a recognized expert in biologics and Advanced Therapy Medicinal Products (ATMP) commercial manufacturing, specializing in Human and Organizational Performance (HOP). With over 15 years of experience, Sarah has held key roles in operations, deviation management, and training management, and has also served as a consultant for large organizations in these areas.

In addition to her professional career, Sarah is dedicated to mentorship and leadership development, currently serving as the Women in Bio Capital Region MAPS Chair, where she supports programs focused on women’s empowerment.

Rocket Pharma is implementing SherpaPharma

We’re thrilled to share that Rocket Pharma, based in Cranbury, NJ, has chosen SherpaPharma’s environmental monitoring software! Rocket Pharma, a leade

Implementing a Robust Viable EM Program

A well-developed viable environmental monitoring (EM) program is essential to the success of those producing sterile drug products and those compoundi

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.

questions about Environmental Monitoring

Answering your questions about Environmental Monitoring (I)

In the fast-paced world of science and technology, environmental monitoring (EM) in laboratories and clean rooms is increasingly important. This pract

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.

Project Manager and Technical Specialist at SherpaPharma |  + posts

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.

environmental monitoring trends in aseptic manufacturing

Navigating change: Unraveling Environmental Monitoring trending in aseptic manufacturing

In the recent webinar titled “Navigating Change: Unraveling Environmental Monitoring Trending in Aseptic Manufacturing,” Vanessa Figueroa provided an

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.

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