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Environmental Monitoring Data Management - Berlin, Germany

: 14 Nov 2018 - 15 Nov 2018

: Berlin, Germany

Sector: Pharmaceutical

Type: Meeting, Training


This course will address the following issues:

  • Overview of controlled rooms classifications, elements of an EM program and present EU and FDA regulations including the recent ISO 14664 changes.
  • How to organize and present an abundant amount of microbial data in meaningful graphs
  • How to draw useful Control Charts with this data, using the software program Minitab®18
  • To understand how action and alert control limits are set
  • How to demonstrate that the environmental microbial monitoring process is under a state of control
  • How to calculate and plot the newly proposed
  • Contamination Recovery Rates in USP Chapter 1116
  • To detect a trend in the environmental microbial monitoring process
  • How to apply risk assessment in investigations
All above issues will be demonstrated on examples and case studies of microbial counts generated in controlled rooms of manufacturing facilities of sterile products.

Click here for more information:
Venue

Berlin
Germany


Organizer

European Compliance Academy
Phone: +[49] 6221-84 44 15
Email: info@gmp-compliance.org
Visit: http://www.gmp-compliance.com


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Superbugs & Superdru...
Next article > >
The Saudi Internatio...