Microbiological Musings

Where quality systems, microbiology, and data-driven thinking meet – translating complexity into clear, actionable outcomes.

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Draft Standards & Consultation Documents

  • ISO-9001-2015-Draft
  • PI_041_1_Draft_2_Guidance_on_Data_Integrity_1
  • 2017_12_pc_annex1_consultation_document

Safety In Laboratories

  • DR 09033 Laboratory design and construction 24/04/2009
  • DR_AS_2243.1 Safety in laboratories (Part 1) Planning and Operational Aspects 24/10/2018 – DR AS 2243.1 – comments and notes
  • DR_AS_2243.2 Safety in laboratories (Part 2) Chemical Aspects 04/10/2018 – DR AS 2243.2 – comments and notes
  • DR 07335 Safety in laboratories (Part 3) Microbiological aspects and containment facilities 22/07/2007
  • DR 09017 Safety in laboratories (Part 6) Plant and equipment aspects 05/03/2009

Random

  • DR_AS_2828.2_2018_PC.pdf 24/10/2018 – Not my specialty. DR AS 2828.2 – comments and notes

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Recent thoughts

  • Quality OS v0.4.1 | Self-hosted Quality Management for regulated manufacturing.
  • Developing a Demonstration Quality Platform
  • Thoughts on Training Systems and Operational Usability
  • Recruitment Isn’t Just Hiring — It’s a Reflection of Your Systems
  • Questions on Cleaning Validation Swab Area

Interesting Topics

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Categories

Viable Environmental Monitoring

https://youtu.be/udTjreyu8dA?si=Jn-2nOo_0z49VB1M

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Method & Equipment Validation

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Autoclave Validation

https://youtu.be/ePIXldT_Vtc?si=unkytkyVIQdNIT5M
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