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PMF Environmental Monitoring 2019

 

Microbiologists play a prominent role in sampling, testing, analyzing and interpreting results for products that are used by millions of individuals around the world.  For products manufactured under cGMP guidelines, the EM criteria are usually quite clear – either the environment is within specified limits or exceeds the limits.  What is not clear is how a result outside the limits may or may not affect product quality and safety.   

This conference is designed to help microbiologists, and their management teams, gain insight into EM and decipher the implications of data that may be at or beyond established limits, as seen from the perspective of industry veterans who have been there, done that.

This conference will focus on environmental monitoring in support of manufacturing including:

 

  • Non-viable vs viable monitoring
  • Developing an EM program
  • Sample site selection
  • EM in non-sterile facilities
  • EM in sterile facilities
  • Setting contamination control limits
  • Trends
  • Recent  FDA Observations
  • Investigating excursions and determining product impact
  • TOC / conductivity
  • EM in the Laboratory

 

Learning Objectives

Workshop attendees will be able to:

  1. Understand the regulatory requirements for EM
  2. Proficiently analyze EM data
  3. Ask poignant questions to uncover unapparent reasons for an EM excursion
  4. Determine the effect of an EM excursion on product safety and efficacy
  5. Determine optimal sampling sites and frequencies
  6. Apply trending data to the analysis
  7. Apply industry best practices to data
  8. Understand the implications of a product failure due to EM
  9. Be confident in defending their position, based upon scientific discipline
  10. Be a better asset to their company

 

Who Should Attend

 The meeting will be of particular interest to microbiologists and microbiology laboratory managers, contract laboratory microbiologists and managers, cosmetic, medical device and pharmaceutical manufacturers, and individuals responsible for disposition of products that are dependent upon EM programs.

For more information and to register, click here!

$200 Early Bird Discount is available until February 22!