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June 2020

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Subject:
From:
"Knutsen, Chris" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Sun, 28 Jun 2020 16:00:03 +0000
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Phil:
Interesting question. I assume, from what you are describing, that this course would be beyond the basic micro courses and more like a choice for a higher level course (what I knew as 200, 300 or 400 level courses).  Therefore, assuming that they have had the basic chemistry and micro classes, I would recommend several topics (in no particular order):
1. Source of the regulations followed, and why (GMP's, History of FDA, general information about international regs (ISO?). It is scary how many people I have interviewed with 5 years or more of pharmaceutical micro experience, who don't know where the GMPS come from (SOPS?) and that they are regulations.
2. Role of FDA (inspections, approvals, 483/warning letters, etc.
3. Basic overviews of pharma manufacturing and how micro interacts.
4. Qualification of facilties, esp with focus on water systems.
5. Roles of other functions in pharma operations, like QA, Regulatory Sciences.
6. Introduction to microbial investigations.
7. Introduction go basic microbiology compendial tests (sterility, mlt, bioburden, etc, identification techniques)
8. Future stare of pharma micro, like Process Analytical Microbiology (Rapid Methods)

And this is just a start.

I hope that the person or persons who do the training actually has experience in pharma micro and will not present topics, such as GMP regs, with an attitude about them.





Chris Knutsen, PhD
Technical Fellow| Microbiology Center of Excellence
Analytical Strategy and Operations

Office +1 732-227-5375
Mobile +1 609-751-8362

Bristol Myers Squibb
1 Squibb Drive
New Brunswick, NJ 08903

bms.com / LinkedIn / Twitter / Facebook / Instagram



-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Tony Cundell
Sent: Wednesday, June 24, 2020 9:51 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] Capabilities

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I must disagree with many opinions expressed by most of the respondents.

A course in general microbiology taught at a state university for students that may work in clinical, food, water microbiology as well as the pharmaceutical industry should include a basic knowledge of the principles of microbiology and as a skill set to work with microorganisms in a laboratory setting. The course in microbiology may

Topics like the development of drug products and their manufacturing processes, GMPs, record keeping, compendial tests are best learnt on the job.

On Tue, Jun 23, 2020 at 11:46 PM Dennis Houlsby <[log in to unmask]> wrote:

> Interpersonal skills, such as the ability to get along with others,
> excellent verbal and  written skills, ability to compromise.  Specific
> technical skills can be taught through on the job training.
> R. D. Houlsby
>
> On 6/23/20, 9:44 AM, "The Pharmaceutical Microbiology Forum Email
> List on behalf of
> [log in to unmask]" <
> [log in to unmask] on behalf of [log in to unmask]> wrote:
>
>     I’m working with a state univ micro dpt to establish
> appliedcapabilities/experience for interested/selected micro students
> (BS) beyond thetypical undergrad curriculum.  For exampleand in
> context of PMF – we anticipate practical/theoretical training re. USP’s51, 61, 62.
>
>
>     If you were looking at a BS level microbiologist fresh fromschool,
> what skills/capabilities would you think esp. valuable in your
> hiringdecision?
>
>
>     Thanks in advance for your thoughts, Phil Geis
>
>
>
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--
Tony Cundell, Ph. D.
Consulting Microbiologist
Email: [log in to unmask]
Phone: 914 725-3947
Cell: 914 841-0074

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Steris - http://www.sterislifesciences.com/

Charles River Laboratories - https://www2.criver.com/l/60962/2020-03-27/h6jqv6

Veltek Associates, Inc - http://www.sterile.com

Microbiologics, Inc. - http://www.microbiologics.com

BD Industrial Media - http://www.bd.com/ds/

Associates of Cape Cod, Inc. - http://www.acciusa.com/


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