Microbiological Risk: Do I Really Need to Test Raw Materials for Microorganisms?

Instructor: Frank Settineri
Product ID: 701396
Training Level: Intermediate to Advanced
  • Duration: 90 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 Microbiological Risk webinar will present reasons why it's in the best interest of a company to test their raw materials: not only from a regulatory perspective but also from a safety and sound business perspective.

Why should you Attend:
Many companies are in a survival mode and need to reduce costs and improve efficiencies wherever possible. One area that seems straightforward is testing raw materials for microbial integrity. Why bother? Won't the manufacturing process kill any microbes that might be residing in the materials? Possibly, yes. But what about an organism that survives, contaminates a product and causes a patient to die? Is your company prepared to accept the consequences of the FDA, lawyers and families demanding restitution? Is your company ready to thwart the assault from the media? How long can your company survive if it has to recall its products and shut down for months before it can start producing again? Are risky cost reductions too risky? Find out the real implications of saving a few cents and if it's truly worth the risk.

Raw materials are receiving tremendous scrutiny from the FDA and other regulatory agencies around the world and have been earmarked as a potential source of uncertainty in the manufacturing of pharmaceuticals, biopharmaceuticals, nutritional supplements and cosmetics. However a prevailing thought is that the processing steps of manufacturing are severe enough to eradicate most microorganisms that may be present in the raw materials. So why worry about the raw materials? Why test them if the manufacturing process will eliminate them? This webinar will present reasons why it's in the best interest of a company to test their raw materials: not only from a regulatory perspective but also from a safety and sound business perspective.

Areas Covered in the seminar:

  • How manufacturing processes eradicate microbes.
  • Why some microbes escape the manufacturing process.
  • Some really bad microorganisms.
  • A changing population.
  • Recent recalls and their disastrous consequences.
  • The true cost of cost reductions.
  • 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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