Environmental Monitoring in Pharma: From Compliance to Control, Driving Inspection Readiness

Environmental monitoring is a cornerstone of pharmaceutical manufacturing, ensuring product quality, patient safety and regulatory compliance across both sterile and non-sterile operations. Yet many organizations struggle to move beyond “check-the-box” monitoring toward a truly risk-based, inspection-ready program that delivers actionable insight.

This webinar provides a practical, real-world view of modern environmental monitoring in pharma, bridging regulatory intent with operational execution. The featured speakers will explore how environmental monitoring fits within an organization’s overall contamination control strategy and how data should be used to demonstrate and maintain control.

Attendees will gain clarity on current expectations from global regulators, including how FDA guidance and EU GMP Annex 1 have reshaped environmental monitoring program design, execution and review. The discussion will address both sterile and non-sterile environments, highlighting where expectations differ and where best practices converge.

The webinar will walk through key elements of an effective environmental monitoring program: risk-based sampling design, viable and non-viable monitoring methods, alert and action limits and data trending strategies that provide early warning of loss of control. Special focus will be given to compressed gas monitoring, often overlooked but critical when utilities such as air, nitrogen or CO₂ contact product or critical environments. Participants will learn how gas quality (viable, moisture, oil and hydrocarbons) integrates into an environmental monitoring strategy and supports contamination control.

Using practical examples, the session will also cover how to interpret environmental monitoring results, recognize adverse trends and respond effectively through investigations and CAPA. Emphasis will be placed on turning environmental monitoring data into meaningful quality intelligence rather than reactive compliance metrics.

Register for this webinar to learn how environmental monitoring in pharma supports contamination control, inspection readiness and a demonstrable state of control.

Speakers

Praveena Dhulipala, Environmental Monitoring Supervisor, BA Sciences

Praveena Dhulipala has been with BA Sciences for four years, where she serves as an Environmental Monitoring Supervisor supporting pharmaceutical and biotechnology manufacturing environments. She brings close to a decade of experience leading and supporting environmental monitoring programs for both sterile and non-sterile operations, with a strong focus on cleanroom compliance, regulatory alignment and contamination control strategies.

In her role at BA Sciences, Praveena oversees environmental monitoring program design, execution, trending and investigation activities across multiple client sites, supporting ISO 5–8 cleanroom environments and performing viable and non-viable air monitoring, surface and personnel sampling, water and WFI collection and compressed gas monitoring. She works closely with Quality, Manufacturing and Engineering teams to ensure environmental monitoring programs are risk-based, inspection-ready and aligned with FDA guidance and EU GMP Annex 1 expectations.

Prior to joining BA Sciences, Praveena served as Microbiology Supervisor at Bio Botanica, overseeing the entire microbiology laboratory after advancing from Microbiology Analyst. Earlier in her career, she served as a Clinical Assistant in a microbiology laboratory, testing patient samples and evaluating microbiological results.

Praveena holds multiple advanced degrees, including a Master’s degree in Biomedical Sciences from Long Island University and a Master of Science in Medical Microbiology and Bacteriology from NTR University of Health Sciences. She also holds a Bachelor of Science in Medical Microbiology and Bacteriology from Jagarlamudi Kuppuswamy Chowdary College. She is also currently pursuing a Master of Science in Biotechnology from Harrisburg University of Science and Technology.

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Bryant Goulet, Environmental Monitoring Team Lead, BA Sciences

Bryant Goulet has been with BA Sciences for four years, where he currently serves as an Environmental Monitoring Team Lead supporting regulated pharmaceutical manufacturing environments. He brings extensive experience leading environmental monitoring programs focused on cleanroom compliance, regulatory adherence and data integrity.

In his role, Bryant conducts and oversees environmental monitoring activities in ISO 5, 7 and 8 cleanroom environments, including viable and non-viable air sampling, surface and personnel monitoring, water and WFI collection, utilities monitoring and compressed gas testing. He leads teams at client sites to ensure consistency, quality and on-time delivery of work, while also supporting the development of new environmental monitoring programs and qualification studies. Bryant is responsible for scheduling and prioritizing projects, mentoring and training microbiologists, performing peer reviews and ensuring all work is executed in accordance with FDA regulations, cGMP requirements and Good Documentation Practices.

Prior to his current role, Bryant served as an Environmental Monitoring Microbiologist supporting pharmaceutical manufacturing sites through routine and investigational sampling at BA Sciences. Earlier in his career, he held progressively senior laboratory roles at Enthalpy Analytical (formerly Envirosystems), advancing from Laboratory Technician to Laboratory Manager. In these roles, he oversaw microbiological and environmental testing programs, supported NPDES and DOD-certified testing, hired and trained staff, maintained quality systems and managed daily laboratory operations. His early career experience also includes ecological risk assessment, microbiological water testing using IDEXX systems and extensive field and laboratory-based environmental testing throughout New England.

Bryant holds a Bachelor of Arts in Biology from Saint Anselm College in Goffstown, New Hampshire. He brings a strong technical foundation, hands-on experience with a wide range of analytical instrumentation and testing methodologies and a leadership style focused on developing teams and delivering reliable, compliant data to clients.

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