Norm Howe is a Senior Partner at Validation & Compliance Institute, consultants for the pharmaceutical and medical device industries. He got his BS at UC, Berkeley, and a PhD in chemistry at UCLA. He has held many management positions in FDA regulated industries, most at BASF. <a href="http://www.vcillc.com" title="http://www.vcillc.com" target="_blank">http://www.vcillc.com</a>