Mark Hallworth is a globally recognized authority in pharmaceutical contamination control, specializing in the design, validation, and implementation of GMP-compliant environmental monitoring systems. With decades of experience, he has led more than 200 projects across cleanroom facilities, focusing on regulatory compliance, data integrity, and system performance. Mark has contributed to the development of particle counters for hazardous environments and 21 CFR Part 11–compliant software for batch release and test management. He has authored over 100 technical papers and contributed to leading industry publications and reference books. Mark frequently presents at international forums, including the Parenteral Drug Association (PDA) and ISPE, where he teaches best practices in cleanroom monitoring and GMP compliance. Additionally, Mark served on the ISO 14644-21 technical committee and received the IEST James Mildon Award for advancing knowledge in contamination control. His work continues to shape standards and practices across the global pharmaceutical and biotechnology industries.

Dave has over 35 years of experience in the pharma and biotech industries, with a focus on contamination control, aseptic processing, and environmental monitoring in GMP-regulated cleanrooms. He has supported the design and implementation of more than 700 environmental monitoring systems around the world, working with leading pharmaceutical manufacturers and engineering firms. Dave has lectured extensively across the U.S. and APAC regions on environmental monitoring strategies and regulatory compliance. For more than 18 years, he has served as an instructor at the Parenteral Drug Association (PDA) headquarters, where he teaches principles of contamination and aseptic control. His work has been instrumental in influencing best practices in cleanroom monitoring and regulatory alignment for the life sciences industry.