A variety of issues with USP <71> make it a difficult test to understand, develop and follow within one’s laboratory.   

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

As a product proceeds through manufacturing to the API with the addition of various excipients, both non-sterile and sterile products (aseptic fill ‘n finish) must be tested for

Data integrity has become a non-compliance area often observed by the FDA and reported within form FDA 483s and warning letters.  While various governments have observed this on

Microbial data deviation investigations come in a multiplicity of forms and may vary from the very simple to include the incubation of a plate at an incorrect temperature to

This Live Webinar takes place at 10.30 AM -12.30 PM ET (New York Time)   Knowledge of the microbiology of water in a GMP environment is