I get constant questions about how to write standard operating procedures (SOPs). Therefore, my next couple of posts will be about SOPs. First you have to stop being intimidated when you are asked to write a SOP. Standard Operating Procedures are nothing more than a business plan. No good business would dare function without a good business plan and that is why the FDA and your management expect you to have them.
Together, you and I are going to write a SOP. So, to start, I want you to think about format, content, who does what, how the task is done and who gets to approve the task. I will come up with one that you actually need which is the standard operating procedure on SOPs. We'll start there next time.
Showing posts with label clinical trials. Show all posts
Showing posts with label clinical trials. Show all posts
Monday, January 5, 2009
Saturday, August 9, 2008
QA Talk
As the unemployment rate in America continue to rise, professionals are exploring opportunities to gain an edge in the interview arena. I'm glad to see this because that means more professionals are realizing the importance of certifications, training and experience. These items are extremely important and the competition out there is fierce! There are a lot of jobs availble in the UK for CRAs. Do you know enough about clinical trials in the UK to work there?
We should always get ready by enhancing our knowledge of research in other countries. Most sponsors conduct multi-centered and multi-cultural clinical trials anyway. Think outside your box. If you spend most of your time working with drug clinical trials, learn something about drug manufacturing and the entire process. At a minimum, you should have a snapshot view of that drug from "development to market". Diversify your knowledge. If you are a CRA, learn what a CRC does. You are probably not there only client so build a relationship with them and learn what a typical CRC day look like. CRC and the PI should take time to learn about the sponsor side of the clinical trial. Find out what happens to all of that data you collected. Diversification is more important than ever, now. I remember when I would go to a training session, the minute the time came to discuss device or tissue practices; I would leave. Not anymore. I want to know about it. I might find myself working in that field someday.
The more I learn now, the better for me later.
What about you? Are you diversifying your experience, your training, your knowledge? I would love to hear about it! Hit comments below and let us know about it.
Until next time......
Have a Quality day!!!
We should always get ready by enhancing our knowledge of research in other countries. Most sponsors conduct multi-centered and multi-cultural clinical trials anyway. Think outside your box. If you spend most of your time working with drug clinical trials, learn something about drug manufacturing and the entire process. At a minimum, you should have a snapshot view of that drug from "development to market". Diversify your knowledge. If you are a CRA, learn what a CRC does. You are probably not there only client so build a relationship with them and learn what a typical CRC day look like. CRC and the PI should take time to learn about the sponsor side of the clinical trial. Find out what happens to all of that data you collected. Diversification is more important than ever, now. I remember when I would go to a training session, the minute the time came to discuss device or tissue practices; I would leave. Not anymore. I want to know about it. I might find myself working in that field someday.
The more I learn now, the better for me later.
What about you? Are you diversifying your experience, your training, your knowledge? I would love to hear about it! Hit comments below and let us know about it.
Until next time......
Have a Quality day!!!
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