T. J. Kuhn | GxP Zone

Good Practice for the Pharmaceutical Industry from the Quality Assurance Perspective

Archive for May, 2008

SQA Thoughts after Catching Up on some Work

Posted by tjkuhn on May 21, 2008

They say that no good goes unpunished….That goes doubly for attending a week-long off-site conference/training. I’ve been back from SQA for over two weeks now and am just getting to a place that might be called “caught up”.

Overall, the conference was good. I had some time away from the office to recharge, reflect, and learn. I saw some old friends and met a few new ones. The pre-conference train courses were quite good:

1) Basic GLP – Pre-clinical is an area in which I haven’t worked directly and I think it is best to always stretch at these opportunities and learn something new. I came in second in GLP Jeopardy!

2) Current Topics in GCP (formerly entitled Advanced Topics in GCP) – This is one of the areas in which I currently live and breath; so I heartily enjoyed this session. It included several former/current FDA employees who really added a lot to the course and the subsequent discussions.

During the conference proper, I focused primarily on Clinical and Validation sessions. There were a lot of good ideas and questions at these sessions too, but I really find that I get a lot more out of the intimate, all-day training classes because of the opportunity to really drill down into a topic and explore lots of related ideas and experiences.

Anyway, I’d better get back to it. I’ve been implementing a training program at work related to “Good Documentation Practices for Clinical Validation Projects” that has been taking quite a bit of time. It has generated a lot of good discussion and the response has been very good. Time permitting, I may post some of my support materials.


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