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Creating FDA-compliant Microbial Contamination Control Program for Biopharmaceutical Manufacturing

  • Training

  • 90 Minutes
  • Compliance Online
  • ID: 5974816
This webinar will enable participants to understand sources of contamination and to investigate various contamination issues in the biopharmaceutical manufacturing of sterile and non-sterile products. Learn how to create an effective Environmental Monitoring (EM) program.

Why Should You Attend:

Contamination issues lead to lengthy investigations and costly recalls. In recent years there have been a number of FDA actions related to contamination issues. Even the largest pharmaceutical multinationals are not immune, as evidenced by recent recalls of drug products. Ensuring the control of contamination within your facility is paramount to the survival of your organization. Creating an effective Contamination Control program is a key to minimizing these problems and ensuring that your company does not end up as the next TV or newspaper headline.

This webinar will discuss various sources of contamination including aseptic processing, clean room classifications and alert/action limits. It will also provide an overview of an effective Environmental Monitoring (EM) program.

Areas Covered in the Webinar:

  • Taking ownership for contamination prevention
  • Sources of microbial contamination
  • Controlling/minimizing microbial ingress
  • Methods of combatting microbial contaminants
  • Limitations of surveillance programs
  • System approach to Microbial control
  • Controlling contamination

Who Will Benefit:

Managers, supervisors and general staff working in the following functional areas:
  • Quality Assurance
  • QC Microbiology Laboratory
  • Aseptic Processing areas Cleaning Services
  • Manufacturing
  • Facilities
  • Facility/Process Design Engineering

Course Provider

  • Henry Urbach
  • Henry Urbach,