Who Needs GMP Training – and When? BioProcess International, December 2019.

The 5 W’s of Quality Agreements, republished by MasterControl, April 2017.

Certificate of Analysis Documentation…Doubtful You Will Figure it Out Later 10 Jan 19

TPP and TQPP – begin with the goal in mind (2-part article) 13 Dec 18

The CTD CMC Section - Say This, Not That – 5-part blog on BLA preparation 19 July, 03 Aug, 13 Sep, 27 Sep, 12 Oct 2018

What Drug Development Programs Can Learn from Stephen Hawking 27 Apr 18

GMP Training: Is Your Company Penny-wise and Pound Foolish? 28 Feb 18

Learning to Speak Acronymish 14 Dec 17

Quality Agreements: The Devil is in the Details. 10 Aug 17

Creating Quality Agreements That Assure Nothing Falls Through the Cracks, FDANews Supplier Quality Management Congress, pre-conference workshop, August 2009

The Potential Impact of the FDA Globalization Act of 2009, webinar, ComplianceOnline, 2008.

Quality Assurance and Quality Management for Drug Importers, webinar, ComplianceOnline, 2007.