EM vs Good Aseptic Technique webinar

The production of modern medicinal injectable products requires good aseptic techniques, a fundamental of manufacturing practices, and/or terminal sterilization, to control the encroachment of the manufacturing environment into a high-risk zone. There are ISO standards and GMP guidelines that promote the application of good aseptic practices, and these are demonstrated using a suitable monitoring program.

So, what suitable environmental monitoring is required to meet the requirements of ISO and the regulatory bodies? This webinar will review how the standards and regulations promote a cohesive environmental program, which is applicable to the risks pertaining to certain manufacturing environments, we will look at manual compounding in laminar flow hoods, through to filling lines, both open and closed systems.

What you’ll learn:

  • Review of the regulatory standards, including the new ISO 14644 Technical Report 21
  • Risks in sterile manufacturing
  • Instrumentation choices associated with the regulatory needs
  • Manual compounding in laminar flow hoods

Who should attend:

  • QA & QC
  • Production and maufacturing teams
  • Environmental monitoring experts
  • Biologists
  • R&D team
  • Biopharmaceutical engineers
  • Regulatory experts
  • Compliance Specialists
  • Facility Managers

 

When? 23rd of April, 3 PM CEST/10 AM EDT

 

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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”.