The meeting was very fruitful as much better discussion always seems to happen when you're sitting around a conference room table versus sitting on a conference call with a a million other distractions.
We discussed a lot of different approaches to addressing areas that were common along each area of the drug development lifecycle (DDLC), which is how the book is structured. We want to make sure that the book is comprehensive yet we also want to avoid getting redundant or repetitive about areas of ITIL that will be written about in each chapter. This is especially important when you have different chapters being addressed by different authors.
We decided to cover the high points of the most common areas in the introduction chapter so that the chapter authors can address specifics to their area within the DDLC.
We also had a great discussion about validation and how does ITIL actually trigger or support those projects. Validation is actually a project within the larger project of developing a drug. Good project management will play a role, yet at the same time (for the purpose of this book) validation appears to be at the intersection of the principles of PMI and ITIL and the FDA's requirements.
In the end, we hope that the book provides a common language and approach for both IT and QA because while both groups have a common goal of supporting the drug development through commercialization, they approach it from different filters serving different masters speaking different languages. While this guide is no Rosetta Stone, it will hopefully bridge the gap enough to make life a little easier for all.
(C)Copyright 2009
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