Pharma
This 5-session webinar series provides a comprehensive, practitioner-led exploration of cleanroom design, airflow visualisation, and qualification requirements under EU GMP Annex 1 (2022), ISO 14644, and FDA aseptic processing guidance. The programme spans cleanroom design fundamentals, smoke study methodology, HVAC engineering, and environmental monitoring strategy. Each session is designed to stand alone but together forms a complete learning journey — from foundational design principles through to inspection-ready qualification documentation.
Cleanroom design and airflow control sit at the very core of contamination prevention in biopharmaceutical manufacturing. As regulatory expectations intensify — most notably with the release of EU GMP Annex 1 (2022) — organisations are under mounting scrutiny to demonstrate that every Grade A and Grade B zone performs as intended, not just on paper, but in live, operational conditions.
This 5-session webinar series, From Smoke to Compliance, is designed to deliver a complete, practitioner-led journey through the engineering, regulatory, and qualification dimensions of cleanroom design. Drawing on the requirements of EU GMP Annex 1 (2022), ISO 14644-1/2, and FDA aseptic processing guidance, the programme equips professionals with the technical depth and regulatory confidence to design, qualify, and defend cleanroom environments at inspection.
Each session has been architected to deliver standalone value while collectively forming a complete learning pathway — from foundational design principles and airflow visualisation methodology, through HVAC engineering and environmental monitoring, to qualification strategies and inspection readiness.
The series is led by practitioners with hands-on experience in cleanroom design, smoke study execution, and regulatory inspection — ensuring that every module goes beyond theory and delivers tools and frameworks directly applicable in your organisation.
This series has been developed for professionals working in or intersecting with GMP-regulated sterile and aseptic manufacturing environments who are responsible for cleanroom design, qualification, environmental monitoring, or regulatory compliance. Whether your focus is engineering, quality, operations, or regulatory affairs, each session delivers directly applicable value.
Understand what has changed under EU GMP Annex 1 (2022) and ISO 14644, translate new requirements into compliant cleanroom quality systems, and build audit-ready documentation for smoke studies and environmental monitoring programmes.
Gain clarity on how regulators are currently interpreting airflow visualisation and cleanroom qualification requirements globally, and understand the inspection expectations for smoke study documentation and HVAC qualification evidence.
Apply Annex 1-aligned design principles to new-build and retrofit cleanroom projects — covering UDAF zone design, pressure differential strategies, AHU configurations, and HEPA filtration approaches that satisfy qualification requirements.
Structure and execute IQ/OQ/PQ protocols for cleanroom and HVAC systems, manage re-qualification triggers, and build qualification packages that withstand regulatory scrutiny during inspections and submissions.
Design and justify a risk-based environmental monitoring programme — viable and non-viable — that aligns with Annex 1 (2022) expectations for sampling locations, alert and action limits, and trend analysis.
Understand the operational implications of cleanroom classification, airflow management, and smoke study requirements — including personnel simulation, intervention protocols, and contamination risk management on the shop floor.
Build strategic oversight across the cleanroom design and compliance landscape to make informed decisions on facility investment, qualification strategy, and inspection readiness.
This series is equally valuable for professionals at pharmaceutical manufacturers, biologic and ATMP developers, CDMOs, CROs, and engineering consultancies operating under EU GMP and FDA regulatory frameworks.
To request an agenda for this Summit, please complete the details below. We will send you the agenda via email.
About Speaker
About Speaker
About Speaker
About Speaker
Varadharaj (Varad) Vijayakumar is an internationally experienced pharmaceutical professional specializing in aseptic processing, sterile manufacturing, and contamination control. He is the author of the best-selling book Mastering Aseptic Processing, widely recognized by pharmaceutical professionals for its practical and regulatory-driven approach to sterile manufacturing.
With more than 16 years of experience in pharmaceutical and biopharmaceutical technical operations, Varad has deep expertise in sterility assurance, aseptic operations, contamination control strategies (CCS), validation, lyophilization, isolator technology, and VHP decontamination. He is known for applying science- and risk-based approaches to resolve complex GMP and regulatory challenges in high-risk sterile manufacturing environments.
Varad currently serves as Associate Director – Aseptic Processing at Terumo Pharmaceutical Solutions GmbH and is Co-founder of Quantum Bio-Consulting. During his career he has held senior technical roles at organizations including WuXi Biologics, Pfizer, Franz Ziel GmbH, Dr. Reddy’s Laboratories, Emcure Pharmaceuticals, Biocon Biologics, and Caplin Steriles.
An active member of ISPE and PDA, Varad is a global speaker and trainer who delivers programs on aseptic processing, qualification, validation, and contamination risk management. He has trained pharmaceutical teams across Europe, the United States, the United Kingdom, Mexico, Thailand, India, and Germany.
Marsha Steed has over 30 years of experience as a microbiologist working in the Pharmaceutical, Biotechnology and Medical Device fields. Marsha is the Founder and President of Steed MicroBio, LLC which is an independent microbiology consulting firm and a Senior Microbiology Associate/Sterility Assurance Expert at Jeff Yuen & Associates, Inc. consulting firm. Marsha is a globally recognized consultant specializing in sterility assurance and contamination control matters in pharmaceutical, biotech and medical device companies.
Marsha served as a USP Microbiology Expert Committee member (2020 – 2025 Cycle) and the chair of the USP Microbial Control and Sterility Assurance Subcommittee. Marsha studied Biology at Western New England University in Springfield, MA. Marsha is active in industry and currently serves on the Parenteral Drug Association (PDA) ATMP Advisory Board and has previously served on the PDA Education Advisory Board (EAB); Scientific Advisory Board (SAB) and has served on numerous PDA Task Forces and meeting planning committees and has been the chair of the PDA Annual Meeting and PDA Microbiology Meeting. Marsha is a former notified body ISO inspector.
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