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Event Dates: 
June 13, 2018 - 2:00 PM to 3:00 PM EDT

Presentation 2

Presentation Summary:

Through this session we will cover all aspects of HCT/P microbiology at a basic to intermediate level. We will review traditional ID or rapid ID such as MALDI-TOF and sequencing, and why environmental monitoring plays a role in this and many more essential details in this aspect of eligibility evaluation.

Learning Objectives:

  1. Outline the basic concept of microbiological testing and evaluation.
  2. Define why method suitability is important.
  3. Identify good and not so good microorganism identifications.
  4. Outline the basics of a log reduction study.
  5. Define expectation of bioburden reduction studies.

Carolyn Jacobs

Carolyn Jacobs

Carolyn has a held a wide range of positions within the laboratory and microbiological arenas, and has over 40 years of dedicated experience in this field. Carolyn has served as a microbiological consultant to multiple renowned laboratories, including LABS, Inc. and VRL Laboratories. Carolyn now owns the firm GMP by CynJay, LLC, a consulting firm which advises multiple eye banks, tissue banks, medical device and biological manufacturers.

In addition to her extensive advisory roles, Carolyn has served as a Senior Scientist & Director of Microbiology at LABS, Inc., Chief Microbiologist/Microbiology Manager at Gambro, Blood Component Technology, and the Production Manager at PASCO Laboratories, a Division of Becton Dickinson. Carolyn holds a bachelor’s degree in microbiology from Colorado State University, and is Regulatory Affairs Certified.

Microbiology 101 of HCT/Ps - Bioburden, Sterility, Environmental Monitoring and the Kitchen Sink

Speaker: Carolyn Jacobs
Date: June 13, 2018
Time: 2:00 p.m. - 3:00 p.m. EST