Drawing from over 20 years of industry experience, gain valuable insights and expert perspectives from a trusted microbiology quality assurance leader and internal auditor.
Updated June 2020:
With the age of my presentation and the recent PE009-14 update it was high time to review and update my Autoclave Validation training/presentation.
The linked to pdf contains Autoclave Validation training I have presented in person and via teleconference. Continue reading
I have experience developing training and presenting it to small to medium sized groups. Part of this process involves determining the way in which to present the training. Once such way to use some form of visuals in support of speaking. For my Microbiology for Non Microbiologists course, I used Microsoft Powerpoint.
Duration of Session:
Recently a company’s HR representative contacted me regarding an “exciting” leadership opportunity in Sydney.
The phone interview went well and I was refered to “management”. They came back and said…. Continue reading
The Question posed on LinkedIn.
“Dear experts..
Is there any links to get the chapters of the GMP manual ?”
My advice:
The ICH link is good as you’ll be able to download the documents various GMP guidance such as PIC/s recommendations and regulatory guide lines such as the Aust Code of GMP (as an example) are based on.
You can then find valuable information on recommendations from sources such as the FDA, eg http://www.fda.gov/downloads/Drugs/…/Guidances/ucm073517.pdf
So we might provide a less general answer, what specifically are you looking for?
Everything related to the production of drugs is based upon a collection of Pharmacopoeia. These contain both guidelines and regulations and are a great source of information (though at times, some interpretation is needed). Continue reading
Let’s examine my traits and how they make me the best choice for your next employment opportunity.
In 2016, I took a DiSC assessment and scored a 6136.
Six for dominance. One for influence (hmmm). Three for steadiness and a final six for Conscientiousness. Continue reading
I have taken part in lots of training over the years. Training is great as if it is new, one learns new things. If the training has been done before, it consolidates or updates existing knowledge. In July 2016, I took part in communication training. Heading into the training, I was interested to see if my communication style had altered since the last time a DiSC assessment was used on me in 2009. As a trained trainer, I know all about communication styles and how to pitch training programs for effective knowledge transfer. Day to day communication is similar and I enjoy observing how trainers train.
In 2009 I took part in training using the DiSC model run by a company called Bridgeworks. From the discprofile website “DiSC is a personal assessment tool used to improve work productivity, teamwork and communication. DiSC is non-judgmental and helps people discuss their behavioral differences.” Then I scored 5223, making me a “panther”. That indicated I had a dominant personality and summed me up as:
In January 2014, Company X advertised for a Lean Leader Microbiology role. My application was successful and I attended both a first and second stage interview.
Though I reportedly excelled during the interviews and seemed to have a good rapport with the interviewers, I “did not have enough team lead experience” and the role went to “an internal applicant”.
This is a little frustrating. I must not have conveyed my eight plus years experience leading teams of 3-15 scientists well enough. Maybe having never had a difficult customer (at least in my opinion) was seen as a weakness. Continue reading
Shortly after beginning my very first microbiology role, I discovered a program called Microsoft Visio was installed on the work computers and it could be used to create diagrams. I was performing a lot of viable environmental monitoring duties at this time and the room maps were in need of improvement. This was the perfect opportunity to improve some documentation. Continue reading
The Question posed on LinkedIn.
“Hi all, I would like to ask you about how to perform cleanroom microbiological environmental monitoring. Is it clearly defined in guides?
TSA and Sab at different temperatures or only TSA? If only one TSA plate, do you incubate at 20-25ºC and then at 30-35ºC, or only at one temperature?
Do you performe growth promotion test in same conditions?
Thank you for your comments!”
My advice:
USP <791> Environmental Monitoring Program Design and Application
USP <1116> Microbiological Control and Monitoring of Aseptic Processing Environments states “….time & incubation temps is made once…media have been selected. Typically…22.5 ± 2.5 and 32.5 ± 2.5…incubation time of 72 & 48 hrs, respectively. Sterilization processes used to prepare growth media for the environmental program should be validated &…media should be examined for sterility & for growth promotion as indicated under Sterility Tests 71. In addition, for the Growth Promotion test, representative microflora isolated from the controlled environment or ATCC strain preparations of these isolates may also be used to test media. Media must be able to support growth when inoculated with less than 100 colony-forming units (cfu) of the challenge organisms.”
So, pick your media. Test it. After that, validate your sampling recovery methods.