Disclaimer: This information was obtained from publicly available sources online and is believed to be accurate at the time of publication. Valimates collects this information with proprietary technology and cannot guarantee the accuracy or completeness of the data. The purpose of the data is to inform the reader about the expertise of the individual and should not be used for any other purpose. Valimates does not have any affiliation with the individual.

James Kolka
James Kolka President at Kolka & Associates

James Kolka stands out as a prolific legal expert and educator deeply versed in compliance regulations and product liability. With over three decades of professional experience, Kolka's impressive credentials include serving as President of Kolka & Associates, where they specialize in litigation support as an expert witness for issues involving CE Marking products, ISO 9001, ISO 13485, and FDA's Quality System Regulation. Their unparalleled legal expertise spans across consulting, training, and performing rigorous quality management system audits, dedicated to ensuring alignment with stringent US and EU directives.

Kolka has a robust network of 3,188 LinkedIn connections, highlighting their extensive influence and reach within the legal and regulatory sectors. Their educational foundation is equally remarkable, holding a Ph.D. in Political Science & International Affairs from the University of Kansas, a JD from the University of Wisconsin Madison Law School, and a BS from the University of Wisconsin Eau Claire, denoting a well-rounded background in law and political science with minors in Chemistry and Economics. Additionally, Kolka is an active member of the Wisconsin Bar.

Not only has Kolka spearheaded their own consultancy firm, but they have also enriched the professional community's understanding of legal implications tied to product liability through conducting over 450 seminars, authoring upwards of 300 articles, and publishing five books on the subject. Their tenure also includes impactful roles in academia where they have served as a professor, imparting their extensive knowledge on diverse topics from European and Latin American politics to environmental law and policy. James Kolka represents an esteemed blend of legal prowess, compliance mastery, and academic distinction, making their contribution to the field unparalleled and invaluable.

More about this expert

Full name
James Kolka
Location
Marietta, Georgia, United States
Title
President
Company
Kolka & Associates
LinkedIn Connections
3188
Summary
Attorney providing US & EU companies and law firms with legal expertise (litigation, expert witness, legal consulting, training, product liability/product safety auditing, risk assessment/hazards analysis). CE Marking compliance for EU Directives (Medical Devices, Machinery & related Directives - Low Voltage, EMC, Explosive Atmospheres, Pressure Equipment, Personal Protective Equipment,Toy Safety) and Cosmetics Directive. Quality Management Systems (ISO 9001, ISO 13485, etc.) and EMS 14001. Regulatory compliance with FDA's Quality System Regulation (QSR). Specialties: Legal expert/expert witness for litigation involving CE Marking products, ISO 9001 & FDA QSR compliance. Training professionals on these areas. Consulting on CE Marking compliance, ISO 9001 & ISO 13485 compliance, FDA QSR compliance. Quality Management System legal exposure audits on product liability/product safety and EMS legal exposure audits on product liability/product safety.
Skills
Powers of Attorney Professor

Education

The University of Kansas
PhD.
Attended in 1963 - 1969
Field of study: Political Science/International Affairs
University of Wisconsin-Eau Claire
BS
Field of study: Political Science/Chemistry/Economics

Positions

Kolka & Associates
Jan 1991 - Present · 33 yrs 1 mo
President
Jan 1991 - Present

Kolka & Associates specializes in:

Litigation - legal expert/expert witness in litigation involving ISO 9001, ISO 13485, ISO 14001, CE Marking in US & EU and FDA's Quality System Regulation QSR

Training - train attorneys & company staff on the legal implications of product liability issues regarding CE Marking for EU Medical Devices Directives, Machinery, Low Voltage, Electromagnetic Compatibility, Pressure Vessels, Explosive Atmospheres ATEX, personal Protective Equipment, Toy Safety and other New Approach Safety Directives, EU Cosmetics Directive, ISO 9001, FDA'a Quality System Regulation QSR, product safety/product liability auditing, risk management, risk analysis/hazards analysis, design control, product liability & loss control,

Consulting - legal consulting on CE Marking compliance with EU New Approach Safety Directives, Product Safety Directive, Product Liability Directive, ISO 9001 and other Quality Management Standards, ISO 13485, ISO 14971, ISO 14121-1, FDA's Quality System Regulation QSR, Compliance & Liability GAP Analysis

Audits - Quality Management System Product Liability/Product Safety Audits (ISO 9001, ISO 13485) FDA's Quality System Regulation QSR & other quality management systems, ISO 14001 Environmental System Product Liability/Product Safety Audits, CE Marking Product Liability/Product Safety Audits, Risk Management Audits & Enterprise Risk Management Audits

Planning - Disaster Preparedness, Enterprise Risk Management, Risk Analysis/Hazards Analysis, Plan "B"

Blog: jameskolka.typepad.com International Regulatory Compliance
Kolka & Associates
Jan 1991 - Present · 33 yrs 1 mo
International Legal Consultant
1990 - Present

Education PhD University of Kansas Political Science & International Affairs, JD University of Wisconsin Madison Law School, BS University of Wisconsin Eau Claire, Political Science (Minors-Chemistry/Economics), Active Member of the Wisconsin Bar

Professor of Political Science (Europe, Latin America, Environmental Law, Environmental Policy @ UW Green Bay, UW Madison, Drake University, Kennesaw State University, Georgia Tech; Senior Academic Planner Univ. of Wisconsin System, Academic VP Drake University, Kennesaw State University

Attorney James W. Kolka PhD, JD is a legal expert in compliance issues & product liability lawsuits regarding ISO 9001, ISO 13485, CE Marking, FDA'sQuality System Regulation

Since 1990 - Attorney, Legal Expert, Litigation Consultant re: ISO 9001 & other quality management systems, ISO 14001, FDA Quality System Regulation, CE Marking Machinery, Medical Devices, Toys, Personal Protective Equipment, Explosive Atmospheres ATEX, Pressure Equipment, EMC, Low Voltage & Cosmetic Directive

Conducted 450+ seminars & workshops for North American, European, Asian & Latin American Companies & Universities; 300+ Articles & 5 Books on Product liability, Product Safety, Forensic & Preventive Law, EU Directives, CE Marking, Technical Standards, FDA, ISO 9001, ISO 13485,ISO 14991, Risk Management & Disaster Preparedness
SAI Global
Senior Consultant
2006 - 2009

Training & Consulting on ISO 9001, ISO !3485, ISO 14001, FDA's QSR, & CE Marking for the EU Medical Devices Directives, Machinery & related Directives - Low Voltage, EMC, Pressure Equipment, Explosive Atmospheres ATEX & Toy Safety, Personal Protective Equipment, Telecommunications Terminal Equipment
Excel Partnership, Inc.
Senior Consultant
1994 - 2006

Training & Consulting for ISO 9001, ISO 13485,
ISO 14001, FDA's QSR & CE Mark Consulting for the Medical Devices Directives, Machinery Directive & related Directives - Low Voltage, EMC, Pressure Equipment, Explosive Atmospheres & Toy Safety, Personal Protective Equipment, Telecommunications Terminal Equipment
Georgia Tech Research Institute
Research Grants Development Administrator
Aug 1989 - Feb 1991

Developed a grants program with division heads to obtain private & public funds to support GTRI research programs, created the Center for International Standards & Quality (CISQ) with external funding grants
Georgia Institute of Technology
Visiting Professor of international Studies
Aug 1987 - Jul 1989

Taught courses in Latin American Politics, Environmental Planning, Environmental Law