Tag Archives: training

The Validation Master Plan

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I was recently asked where I would start if I was tasked with developing the Validation Master Plan or VMP for a microbiology laboratory.

That got me thinking. I’ve done my share of validations over the years, encompassing such things as viable particle air samplers, large format incubators, temperature mapping, autoclave validation, sterile media trials, computer system validation and various microbiological test methods. I’ve also written validation documentation in the form of user requirement specifications (URS), installation qualifications (IQ), operational qualifications (OQ), performance qualifications (PQ) as well as the validation protocols and reports. To take on the task of developing the master plan would be challenging and to my mind, an exciting and fun/rewarding project. I love documentation! Continue reading →

Writing Technical Reports

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What is technical writing?

Technical writing is a style of writing used when preparing protocols, reports, investigations and other laboratory documentation.

What are some examples of technical documents?

In general, any regulated manufacturing site will use the following technical documents: validation documents, reports, Standard (Operating) Procedures, SOP’s and Work/Operator Instructions (OI’s), standard forms and overriding policies and a Site Quality Manual all within the framework of a Quality Management System (QMS), Continue reading →

The Importance of Trending

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What is Trending?

Trending, when used in a pharmaceutical microbiology laboratory, is the examination of long term data in order to examine if a controlled process is moving away from the state of control. Trending can also be used to determine the stability of a product’s efficacy by examining the results of testing over time. Stability trends are important to support expiry dates and storage conditions. Continue reading →

Viable Environmental Monitoring

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This was repurposed into a LinkedIn article as part of my Developing My Writing While Helping Others series.

What Is Viable Environmental Monitoring (VEM)?

Viable Environmental Monitoring (VEM) is the monitoring of factors within a production environment that may have an impact on the quality of goods produced within the environment. Typically this is any physical object than could support or introduce microbial contamination to a manufacturing environment: air, gases, surfaces (both on introduced objects and within the production room), liquids and people.  This discussion does not extend to Environmental Monitoring such as particle counting, temperature, pressure differentials, etc. Continue reading →

What Makes An Objectionable Organism?

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What is a specified organism?

A specified organism is one that according to the pharmacopeia, cannot be present in a sample (usually 10g). These microbes are specified either as they may be an indicator organism (a microbe where its presence may indicate a pathogenic microbe could be present) or they may actually pose product safety concerns (whether by reducing the efficacy or posing a risk to the end user). Continue reading →

The Need for Documentation

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“If It Was not Documented, It Was Not Done”

Reviewed and updated July 2020.

At one time there were three monkeys locked in a room. This room also contained a banana, suspended by a cord from the ceiling in the centre of the room. Whenever one of the monkeys grabbed the banana, all the monkeys were subjected to an icy cold shower. After several repetitions of this shower, no monkey in the room would touch the banana. Continue reading →

Finally Dabbled with Moodle

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For a while now I have had the idea to turn a power point presentation I developed a number of years ago into an online learning module. A couple of weeks ago, I set up a domain specifically for playing with Moodle and installed it. I then had to uninstall it as my host’s server’s version of SQL is a bit long in the tooth to support the current version. Once I found a compatible version I unzipped it on my server, set up a database with a couple of test users and had a click around the installation.

I had no troubles creating a course directory structure, but how one went about adding content boggled my mind (it was probably 3 am when I did all this).

This evening, I thought I’d have a fresh look at things and after about 3 hours of referring to my old power point presentation, I’d ported enough information from it to make a fairly decent, but basic and no frills training package on how to control microbes in the home.

Looking at things, if (and when) I have a go at developing some more training modules, most of the fancy formatting will probably be done in Dreamweaver and then copied across to Moodle as I’m not too keen one the provided text editor.

If you want to check it out, click here to learn a little about microbiology. (link’s dead as I’ve removed the site – Jan 2016)