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 around environmental monitoring and providing practical solutions.
Attend this interactive webinar to get answers to common questions, learn what the auditors will be expecting 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
- Facility managers
- Purchasing and procurement specialists
- Operations managers
- Compliance specialists
When? June 15th 2023, 8 AM PST/4 PM BST
Our presenter will break the ice by replying to some of the most frequently asked questions we collected in these last few months, but we want to hear from you. The webinar will be completely interactive, and our expert at your disposal to answer any questions you may have on Annex 1.
Can’t attend? Register anyway, we will send you a recording afterwards!
Mark Hallworth is the Life Sciences Global Manager and Senior GMP Scientist at Particle Measuring Systems. Over Mark’s long career in contamination control, he has managed the design, installation, and validation of over 200 environmental monitoring system projects worldwide. He has designed several products specific for pharmaceutical environmental monitoring, including particle counters for explosive and corrosive areas and 21 CFR part 11 compliant software for batch test and release. He currently lectures for the PDA, ISPE, and other international pharmaceutical societies on environmental monitoring and GMP compliance design and validation. Mark has written over 100 technical papers on environmental monitoring and contributed to several books specific to this field. He was awarded the IEST James Mildon award for “significant contributions to the advancement and increase of knowledge in the field of contamination control”.