Regulatory Open Forum

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  • 1.  Basic Microbiology Lab Course

    Posted 23-Sep-2020 13:07
    Ladies and Gentlemen,

    Can any one recommend a course that would teach a lab technician how to accomplish basic microbiological testing, GLP, lab technique, etc?  Any recommendations would be appreciated.

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    William Coulston PMP, MS, RAC
    Quality & Regulatory Manager
    San Antonio TX
    United States
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  • 2.  RE: Basic Microbiology Lab Course

    Posted 24-Sep-2020 02:36
    Hi William,

    I couldn't recommend something specific, but most of the big laboratories are performing such trainings throughout the year.

    If you want in vitro techniques, because you mentioned GLP, you can search altertox or anything similar.

    Hope that helps

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    Spyros Drivelos
    Medical Devices Expert, RAC
    Agia Paraskevi, Athens
    Greece
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  • 3.  RE: Basic Microbiology Lab Course

    Posted 24-Sep-2020 03:42
    Hello William,

    Usually that type of training is acquired "on the job" when an employee works for a testing lab or central lab like LabCorp, or from an hospital, or other CLIA/CAP certified labs.  If you are looking for training for your internal employee there are a few options would be seeing if a certified lab does offer training on different types of tests or GLP aspects, do some job sharing between the your company and theirs, or even taking a course at a university some offer advanced microbiology classes.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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  • 4.  RE: Basic Microbiology Lab Course

    Posted 24-Sep-2020 08:29
    Hi William.

    Keep it simple - most colleges that have any sort of health sciences programs have a basic intro course for Microbiology.  To me, if you want someone to "learn" a technique this is the place to start.  Remember - many of these other suggestions may be good at the "book" work but the practical in many instances does not match up to the book work in terms of level of detail or understanding why certain things might happen.  If you truly have someone unfamiliar or who has not done micro before, "learning" from many of these other places is a risky business in terms of money and time and most importantly, technique.  But hey - that's just from the perspective of someone who did this sort of work for the first 9+ years of my career!  :)

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    Victor Mencarelli
    Global Director Regulatory Affairs
    MelvilleNY
    United States
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  • 5.  RE: Basic Microbiology Lab Course

    Posted 24-Sep-2020 11:59
    The community college is a good place to start to learn basic microbiology. The course should include a laboratory component.

    I have been successful in teaching persons not familiar with microbiology to perform routine bioburden testing, sampling with contact plates and air-samplers, LAL testing, and testing of biological indicators, e.g. transfer and interpretation. These technicians undergo several assessments using unknown samples to assess proficiency in aseptic technique, interpretation, etc. Training and on-going management of these technicians is by a qualified microbiologist (4-year degree in micro and certified specialist in pharmaceutical/medical device/cosmetic microbiology).

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    Melissa M. Traylor
    Regulatory Affairs
    FzioMed, Inc.
    San Luis Obispo, California
    USA
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