Objectionable Microorganisms in an Aseptic Environment

Instructor: Frank Settineri
Product ID: 701376
Training Level: Intermediate to Advanced
  • Duration: 90 Min

recorded version

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Training CD

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This Objectionable Microorganisms webinar examine alternative avenues that allow a product to be saved. Will explore the current practices that define objectionable microorganism and provide practical approach to determine how objectionable really is.

Why should you Attend:
Two basic tenants - microorganisms are everywhere and companies must increase environmental surveillance - result in the unimaginable happening: finding an objectionable microorganism in your aseptic core! Is it time to hit the panic button? It might be. Or it might not be. This webinar will help you decide what to do, base upon science, logic and trends in your plant. It can be your nirvana to enable you to survive in the risk-averse culture we all live.

It's generally recognized that a sterile product should contain zero microorganisms in it, and sterile manufacturers take extreme measures to exclude all microbial growth. They build aseptic cores, isolators, sophisticated monitoring and eradication systems and spend countless time and money on training their staff to be aseptic.

Despite all the equipment, training and scrutinizing they perform to exclude microorganisms, eventually the unimaginable happens: they find an objectionable microorganism in their aseptic core! Why? How can this be? The answer resides in two basic tenants - microorganisms are everywhere and since companies dramatically increased their environmental surveillance they have inadvertently increased the probability of finding an organism in their facility. So when this happen what do you do? Immediately hit the panic button, reject your product and shut down the plant? (Some companies actually do this). Or take a more rational approach and use empirical data and sound investigative principles to make a logical decision?

This webinar will examine alternative avenues that may allow a product to be saved. It will explore the most current practices that define an objectionable microorganism and will provide a practical approach to determine just how objectionable it really is. It will help you decide what to do, base upon science, logic and trends in your plant and may allow you to construct an iron clad argument for releasing your product - even in the risk-averse culture that currently dominates our industry.

Areas Covered in the seminar:

  • What does aseptic mean?
  • How do I make my plant aseptic?
  • What is an Objectionable Microbe?
  • What's the risk if I find an OM?
  • How do I conduct a risk assessment?
  • Examples
  • Questions

Who will benefit:

  • Quality system auditors
  • Senior Management responsible for making final decisions
  • QA directors and managers
  • Information Technology managers and personnel
  • Microbiology analysts and technicians
  • Consultants
  • Regulatory and Compliance Management

Instructor Profile:
Frank Settineri, is the founder and President of Veracorp LLC, a consulting firm that specializes in providing pharmaceutical, biotech, medical device and startup companies with the essential advice they need to keep their businesses running efficiently and within regulatory guidelines. With over 30 years of pharmaceutical business, manufacturing and laboratory experience he is an authority on FDA Warning Letters and 483s, GMP compliance, validation planning, outsourcing, microbiology, sterile and non-sterile manufacturing issues. He learned from the best mentors and brings a unique over site to the industry that has made and saved millions for his clients.

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