Looking forward to attending the upcoming MHRA GMDP Symposium in
Glasgow. It's interesting to note the topic of discussion for the GMP
section will be on contamination control strategies. Clearly a hot
topic just now.
bioSYNERGY Consulting are offering a two-level course on biocontamination control suitable for any facility operating withing a clean room or other controlled environment.
The series is structured around the level of microbiology knowledge, with the end goal of providing an overall understanding of biocontamination and what it takes to establish a robust biocontamination control strategy. Level 1 is suitable for either non-microbiologists or those with a limited understanding of
microbiology, and will provide a knowledge foundation of biocontamination and its sources. Level 2 builds on this knowledge and is suitable for those more experienced in microbiology and looking to establish a biocontamination control strategy or
investigate biocontamination events.
Each course will cover the following areas:
Level 1
* Introduction to biocontamination and basic microbiology
* Assessing potential biocontamination sources
* Clean room behaviour
Level 2
* Developing a robust biocontamination control strategy
* Designing and implementing an environmental monitoring program
* Establishing an effective cleaning process and validating against EN standards
* Quality risk management strategies for investigating biocontamination events for:
a) Environmental monitoring excursions
b) Product biocontamination events
These courses can be adapted to be bespoke to your manufacturing facility, and can either be run on-site or off-site depending on numbers and room space.
Please send an email to info@biosynergyconsulting.co.uk
or use the CONTACT US
tab to find out more.
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