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.
Was great to see some old faces and meet some new contacts at the HPCi Cleanroom Technology Conference last week.
The discussions were very topical covering the recent regulatory changes to both Annex 1 and ISO 14644. It was particularly interesting to see the latest advances in technology to allow real time viable particle monitoring, and this will undoubtedly become an invaluable tool to be able to investigate and ring fence contamination excursions during the manufacturing process. It will be interesting to see how these processes will be implemented and how the regulations will respond over the next few years.
We have recently launched our new Facebook page to keep you up to date with new services we offer and when we will be attending various events around the country. If you would like to receive updates then please click the "like" button!