3 Hours Virtual Seminar: Creating FDA-Compliant Microbial Contamination Control Program for Biopharmaceutical Manufacturing

Henry Urbach

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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. The webinar will also provide an overview of an effective Environmental Monitoring (EM) surveillance program.

Course Objective

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.

Course Outline

  • Taking ownership for contamination prevention
  • Sources of microbial contamination
  • Controlling/minimizing microbial ingress
  • Methods of combating microbial contaminants
  • Limitations of surveillance programs
  • System approach to Microbial control
  • We are all responsible for controlling contamination

Target Audience

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

Webinar Events
Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Henry Urbach,

Henry Urbach is the founder of GMP Training, Development and Consulting. GMP TDC LLC is a New York-based consulting organization serving Life Sciences industries. Henry has 25+ years of Life Sciences experience having held positions of increased responsibility in GMP Training and QC Microbiology. His experience includes managing GMP compliance and quality systems training, implementing a training program as part of a post-regulatory action remediation, and developing a contamination control and environmental monitoring training program for major pharmaceutical and biotechnology organizations. He is a dynamic speaker specializing in FDA and ICH compliance. He is also a CQA Certified Quality Auditor. His technical education is further complemented by his BA degree in Biology and MBA, which provide a scientific and business insight. He is a member of the ASTD, ASQ, and GMP TEA, a national organization of Life Sciences training professionals.

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