Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing

Instructor: Henry Urbach
Product ID: 702634
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section

Training CD

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Read Frequently Asked Questions

This 60-minute webinar will show how you can design a robust microbiological audit program for pharmaceutical and biopharmaceutical product manufacturing, that effectively assesses your facility and that of your supplier to ensure your facilities and products are free from microbial contamination.

Why Should You Attend:

The risk of non-compliance related to microbiological causes is too great, in terms of fines, potential law suits, loss of consumer confidence, and ultimately, the bottom line. This means that biopharmaceutical manufacturers must prove that their facilities and products are free from contamination.

This webinar is designed to help organizations understand that preventing microbial contamination is the responsibility of everyone in the organization, and that everyone must play a part in it. Attendees will learn how to create a robust inspection program that includes auditing for potential sources of microbial contamination.

Areas Covered in the Webinar:

  • What do regulations say about the subject?
  • Sources of contamination
  • Preventing contamination
  • Controlling contamination
  • What about the suppliers?
  • Everyone has a role in contamination control

Who Will Benefit:

This training webinar has been designed for the following personnel in pharmaceutical, biopharmaceutical and medical device companies:

  • Quality assurance personnel
  • Quality control personnel
  • Microbiology professionals
  • Validation
  • Manufacturing
  • Quality system auditors
  • Warehouse managers
  • Facilities/maintenance
  • Regulatory and compliance management

Instructor Profile:

Henry Urbach, is the founder of GMP Training, Development and Consulting, GMP TDC LLC, a New York-based consulting organization serving Life Sciences industries. He has 20+ 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 an environmental monitoring training program for major pharmaceutical and biotechnology organizations. He is a dynamic speaker specializing in FDA and ICH compliance. He is a 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.

Topic Background:

In recent years the number of recalls related to microbiological causes has been on the rise. FDA regulations, 21 CFR 210 and 211, mandate that biopharmaceutical products must be pure, safe and effective. To comply with these regulations each organization must create a robust inspection program that includes auditing for potential sources of microbial contamination.

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