Within a Manufacturing Environment, cGMP microbiological issues always arise that require addressing. Whether the facility is considered to be a Controlled or Classified environment, whether it is manufacturing non-sterile or aseptically filled product, the Microbiology Environment of the product is critical to assuring products leave the facility with the microbiology specifications in control.  As the facility is examined in additional detail, the environment also must be considered. Both airborne viable and non-viable particulate considerations must be explored and controlled within all areas from ISO 5 to 8. The water systems, which include potable water, purified water and water for injection, will also be explored regarding their specifications, maintenance, and compliance. 

Obtain an enhanced understanding as well as a “refresher” of what requirements exist for the microbiologist throughout the production environment from in-coming through final release. A review of Case Studies/Warning Letters pertinent to the microbiologist’s environment will be conducted.

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