James W. Kolka, Ph.D., J.D.
Advisory Board

Dr. Kolka's professional experience spans more than 30 years. During this time he served as a full professor and senior administrator at several public and private universities. As an attorney, he has dedicated the last decade of his distinguished career to the quality and environmental fields by developing a comprehensive preventive law program that utilizes both the ISO 9001 and ISO 14001 to reduce product, services and environmental liability for the US and EU markets. Furthermore, Dr. Kolka developed programs to apply ISO 9001:2000 as a platform for risk management and disaster preparedness.

Dr. Kolka brings the following experience to the Pinnacle family:

• Developed integrated regulatory compliance programs for machinery, medical devices, and medical device packaging for Europe (CE marking) and the US (FDA's Quality System Regulation).
• Developed programs utilizing ISO 9001 and ISO 14001 to reduce liability exposure in the manufacturing and services sectors in both regulated and non regulated industries of the US and EU.
• Conducted more than 400 seminars and workshops for North American, European, Asian and Latin American companies and has written more than 250 articles and five books on the topics of liability, EU Directives and technical standards, ISO 9000, ISO 14000, liability, risk management and disaster preparedness.