Annex 1 Questions & Answers

On Demand

Industry expert answers the top questions we have received regarding Annex 1

EU GMP Annex 1 has been released after much anticipation, and new revisions tend to cause confusion. An industry-leading expert in Annex 1 and regulations is available here, answering common questions about environmental monitoring and providing practical solutions.

Attend this interactive webinar to get answers to common questions, learn what the auditors will expect and how to meet those expectations, and get your own questions answered.

In this free webinar, you’ll:

Get clarity on Annex 1 requirements
Learn what the auditors will be expecting
Get practical Annex 1 insights from one of the industry’s top regulatory experts
Learn what has changed and what was stayed the same in Annex 1 revisions

Who should attend:

All professionals involved in GMP sterile manufacturing, especially:

Quality assurance
Quality control
Production and project managers
Engineers
Facility managers
Purchasing and procurement specialists
Operations managers
Compliance specialists

Webinar Presented By:

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.