Designing a Facility Monitoring System to Meet the Annex 1 Requirements for Data, Reporting, and Interpretation
This presentation will cover requirements of designing a continuous system in Grade A spaces, practical advice on what to do with the data.
The revision of Annex 1, Chapter 9 on Environmental Monitoring includes several new elements around the design of a continuous system in Grade A spaces, along with guidance for establishing appropriate alert and action thresholds. This presentation will cover those requirements alongside practical advice on what to do with the data, how to generate suitable reports that confirm the maintenance of the environment and how to interpret the data to ensure that correct responses are being made to real out of tolerance events.
What’s in it for me?
This free live virtual event features 20-minute presentations by experts from leading pharmaceutical processes and packaging equipment manufacturers. You’ll see current solutions available for your specific requirements and will be able to submit questions and get a reply in real time.
Who should attend:
- Pharmaceutical manufacturers
- Industry consultants
- Engineering
- Manufacturing Teams
- Technical operations
- R&D
- Formulation
- Maintenance
- Procurement
- Quality Assurance and Quality Control
Speakers
Mark Hallworth
Global Pharma and Sr. GMP Advisor, Life Sciences Division
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.
