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 the Life Sciences Global Manager and Senior GMP Advisor 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. Most recently, Mark was a member of the international ISO 14644-21 technical committee responsible for reviewing and revising the standard. He was awarded the IEST James Mildon award for “significant contributions to the advancement and increase of knowledge in the field of contamination control”.