Q9 Consulting, Inc. was founded in 2007 by Mike Wakshull. The name originates from ICH Q9, Quality Risk Management for the pharmaceutical industry. Mike managed Corporate Quality Risk Management for Amgen, the world's largest biotechnology company. Mike's experience with medical device product risk management has focused on implementation of ISO 14971.
Mike was a technical editor and primary contributor to the 2nd edition of the risk management chapter 11 of the Guide to the Project Management Body of Knowledge (PMBoK Guide). This is an ANSI and ISO standard for project management. He has contributed to the risk management chapter of the 4th edition of the PMBoK Guide.
In 1999 Mike wrote the first 4-day Project Risk Management course for Learning Tree International. In 2002 he presented 2 4-day risk management classes for PMI Seminars World. Mike teaches project risk management for the University of California at Irvine's Extension University. He wrote and presented globally the internal Product Quality Risk Management training classes at Abbott Vascular.