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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.

Digital Environmental Monitoring

Navigating the Digital Frontier of Environmental Monitoring with Automation

In recent times, a resounding buzz surrounds the imminent trend of digitalization and automation. Beyond buzzwords, these trends are poised to reshape

Navigating 2023: A Year in Review with SherpaPharma

As the year 2023 comes to a close, at SherpaPharma, we wish to reflect on a year filled with challenges and achievements. We’ve faced the implementati

The importance of Environmental Monitoring data to improve your contamination control strategy

Annex I makes it very clear that the Contamintation Control Strategy is a living and reviewable document. Therefore, the analysis of environmental mon

Contamination Control Sales Manager | + posts

Laura holds a Bachelor's degree in Chemical Engineering from the University of Jaime I in Castellón de la Plana. After several years working as a Product Manager in the Ceramic Industry, she moved to Madrid to continue her professional career in the Pharmaceutical Sector.

She began working at Tiselab in 2011, taking on roles as a Commercial Technician and Product Manager for Cleanrooms and Disinfection in the Central/Southern regions of Spain and Portugal. In 2021, she assumed her new role as Commercial Manager for the Contamination Control division.

Poster: Expecting more from your EM software

It seems that a discussion on trend analysis for environmental monitoring was just what the 2023 PDA Pharmaceutical Microbiology conference needed. Co

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.

Our blog on Environmental Monitoring in the pharmaceutical industry during 2023

The time to implement Annex 1 has come to an end. During this 2023 our specialists have shown the importance of environmental monitoring to carry out

Environmental Monitoring using Laminar Air Flows (LAF) in Pharmaceutical Sterile Compounding Sites.

Pharmaceutical compounding sites are facilities where pharmacists or specially trained personnel prepare customized medications based on the individua

General Manager at  | + posts

Santi studied telecommunications engineering and an MBA. Since 2005 he works at Tiselab, where he has helped to consolidate the current team, achieving sustained growth, and diversifying the company into various divisions. In 2016, he started the SherpaPharma project after realizing that pharmaceutical companies had an opportunity for significant improvement in Environmental Monitoring.

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Santi estudió ingeniería de telecomunicaciones y un MBA. Desde 2005 trabaja en Tiselab, donde ha ayudado a consolidar el equipo actual, consiguiendo un crecimiento sostenido y diversificando la compañía en varias divisiones. En 2016 inició el proyecto SherpaPharma al ver que en las compañías farmacéuticas había una oportunidad de mejora importante en la Monitorización Ambiental.

 

Project Manager at  | + posts

Enric Adserà has a degree in Chemistry, Chemical Engineering and MBA from ESADE. Since 2018 he works in Tiselab as Project Manager of SherpaPharma providing his experience and knowledge in the application of Environmental Monitoring solutions in the pharmaceutical industry.

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Enric Adserà es Licenciado en Químicas, Ingeniería Química y MBA por ESADE. Desde 2018 trabaja en Tiselab como Project Manager de SherpaPharma  aportando su experiencia y conocimientos en la aplicación de soluciones de Monitorización Ambiental en el sector farmacéutico.

Streamline the process of microbiological plate counting

In sterile manufacturing laboratories, 95-99% of environmental control plates show no growth after the sampling and incubation process. However, in or

Management of Original Environmental Sampling Data

The principles of ALCOA+ on Data Integrity in the pharmaceutical industry includes the need to save the Original Data from the process. As described i

Project Manager at  | + posts

Enric Adserà has a degree in Chemistry, Chemical Engineering and MBA from ESADE. Since 2018 he works in Tiselab as Project Manager of SherpaPharma providing his experience and knowledge in the application of Environmental Monitoring solutions in the pharmaceutical industry.

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Enric Adserà es Licenciado en Químicas, Ingeniería Química y MBA por ESADE. Desde 2018 trabaja en Tiselab como Project Manager de SherpaPharma  aportando su experiencia y conocimientos en la aplicación de soluciones de Monitorización Ambiental en el sector farmacéutico.

Is your Environmental Monitoring in line with the new Annex 1?

The 2022 version of the GMP Annex 1 defines some stringent requirements in relation to Environmental Monitoring. August 2023 is the deadline to comply

General Manager at  | + posts

Santi studied telecommunications engineering and an MBA. Since 2005 he works at Tiselab, where he has helped to consolidate the current team, achieving sustained growth, and diversifying the company into various divisions. In 2016, he started the SherpaPharma project after realizing that pharmaceutical companies had an opportunity for significant improvement in Environmental Monitoring.

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Santi estudió ingeniería de telecomunicaciones y un MBA. Desde 2005 trabaja en Tiselab, donde ha ayudado a consolidar el equipo actual, consiguiendo un crecimiento sostenido y diversificando la compañía en varias divisiones. En 2016 inició el proyecto SherpaPharma al ver que en las compañías farmacéuticas había una oportunidad de mejora importante en la Monitorización Ambiental.

 

White Paper Vanesa Vasadi Figueroa

White Paper: Environmental Monitoring in cleanrooms. Six factors to consider when evaluating a digital system

We are honored to present this interesting White Paper in which Vanesa Vasadi Figueroa reviews six key factors for the decision process of selecting s

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.

Welcome Focus Laboratories

FOCUS Laboratories is implementing SherpaPharma

We are excited to share the news that FOCUS Laboratories is implementing SherpaPharma’s EM Software solution to streamline and enhance their environme

Monitorización ambiental en la estrategia de control de contaminación

Environmental Monitoring in contamination control strategy

How to use the results of Environmental Monitoring for a good definition and compliance with the Contamination Control Strategy (CCS). We would now li

Project Manager at  | + posts

Enric Adserà has a degree in Chemistry, Chemical Engineering and MBA from ESADE. Since 2018 he works in Tiselab as Project Manager of SherpaPharma providing his experience and knowledge in the application of Environmental Monitoring solutions in the pharmaceutical industry.

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Enric Adserà es Licenciado en Químicas, Ingeniería Química y MBA por ESADE. Desde 2018 trabaja en Tiselab como Project Manager de SherpaPharma  aportando su experiencia y conocimientos en la aplicación de soluciones de Monitorización Ambiental en el sector farmacéutico.

La resistencia al cambio en los procesos de monitorización ambiental

Resistance to change in Environmental Monitoring processes

In a laboratory or clean room, the specialists in charge of the production of medications who work with Environmental Monitoring data perceive the imp

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