Returning from Puerto Rico to another week of below zero temps in Minnesota. Welcome home?!?
The three days of committee meetings were actually extremely effective. As always, a lot of passionate people offering great insights and wisdom for the purpose to provide effective and valuable standards for the Pharmaceutical process industry.
This is a view from the conference room. A bit of a distraction but the conversation was compelling so staying focused was easy.
I had an interesting conversation about the validation process. From an instrument perspective the idea is to consider validation of alternate instruments from a Form, Fit and Function analysis, rather than requiring an entire system validation effort. This could have some traction, but plenty of work and justification needs to be pursued. Maybe next meeting.
I also had the opportunity to lead various discussions on the topic of temperature measurement instruments, creating a definition as well as what guidance would best serve the Pharma industry. As part of the sub committee on Process Instrumentation, of which I am now an official member, I am leading the Task group to draft the section on Temperature Measurement Instruments. The Process Instrumentation section is scheduled for inclusion in the 2012 version of the BPE standard. The pressure’s on because the temperature section is intended to set the format and structure for all other instrument sections. Exciting stuff.
Over the next several months the Task Group which includes new friends from Anderson Instruments, Weed Instruments and Genentech, will collaborate via email in preparation for the next meeting; October in Boston.
I am honored by the opportunity!