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Training and Communication


Knowledge management is essential for organizational learning and improvement, and it is a requirement for quality and innovation management systems. Keathley and Company provides services in training and documentation in medical product research and development, as well as compliance auditing services.

Training Expertise

  • Merrill, P, Keathley J; Never Stop Innovating! Workshop; ASQ BOSCON; Waltham, MA; Apr 2016
  • FDA Quality System Regulations and Quality Management System training; multiple sessions for clients (2012 - current)

  • Keathley J: Innovation Basics – It’s Not Elementary, Workshop; SPQA Forum, Richmond, VA, Sep 2014

  • Innovation Live! Workshop, World Conference on Quality and Improvement, Indianapolis, IN May 2013
    • Presented at ASQ Member Unit Leader training and National Quality Education Conference, both in November 2013
  • Chair, Education and Training, Virginia Senate Productivity and Quality Award (SPQA) program; 2014 - 2015)
    • Trainer; SPQA, 2012 and 2013 cycles
    • Baldrige Criteria for Performance Excellence
    • SPQA Examiner Training
  • FDA Quality System Regulations, Alere/Medical Automation Systems (MAS); multiple sessions for employees
  • MAS Quality System Training; multiple bi-annual sessions for employees
  • MAS Internal Auditor training; multiple sessions
  • Adjunct Instructor, Medical Microbiology and Biology, Johnson County Community College, Overland Park, KS (1994-1996)

Publications 

  • Keathley, J. Knowing When You've Added Value; Qualtiy Progress, March 2019, pp 16-23
  • Keathley, J; Innovation Planning Using Non-traditional Methods; Technical Paper, WCQI, Milwaukee, WI, May 2016
  • Keathley, J; Is it Innovation or Improvement? ASQ World Conference on Quality and Improvement 2014 Proceedings
  • Keathley, J; et al.; The Executive Guide to Innovation; American Society for Quality (ASQ) Quality Press © 2014
  • Keathley, J; Innovation and the Quality Manager of the Future; Quality Progress 45:6, June 2012
  • Keathley, J; Book Review ‘Switch: How to Change Things When Change is Hard, by Heath and Heath; Quality Management Forum, Summer 2012
  • Keathley J.; QMS: A Model for Lab Services GP26-A4; Lab Medicine, 43, 26-28 (2012)
  • Keathley, J and Owens, T; Putting Quality Tools to Work for Innovation, Technical Paper;  ASQ World Conference on Quality and Improvement (WCQI) 2010 
  • Keathley, et al., Innovation-Driven Organizations: What, Why and How (A Review of Methods for Innovation Management); QMD Forum, Spring 2010
  • Keathley, Jane; Innovation and the Baldrige Criteria: Can They Coexist?;  Performance Counts, Newsletter for Virginia SPQA, Fall 2009

Presentations

  • Keathley, J; Cybersecurity and the QMS; WCQI, Ft. Worth, TX, May 2019
  • Keathley, J; Innovation Planning Using Non-traditional Methods; World Conference on Quality and Improvement (WCQI), Milwaukee, WI, May 2016
  • Keathley J; Using Value Analysis for Innovation Project Management; Joint Session ASQ Blue Ridge Section 1108 and PMI-CHO chapter; Charlottesville VA, Feb 2016
  • Keathley, J (moderator); Leveraging Quality for Innovative Medical Devices, Panel Discussion; ASQ Innovation Conference, Charlottesville VA Sep 2015
  • Benson K and Keathley J; Music Outside the Box; WCQI, Nashville, TN, May 2015
  • Keathley, J; On-Going Success in Innovation; WCQI 2014, Dallas, TX
  • Keathley, J; Is it Innovation or Improvement?; WCQI 2014, Dallas, TX
  • Keathley, J; The Pathway from Quality to Innovation, ASQ Innovation Conference, Sacramento, CA, October 2013
  • Keathley, J; Innovation in the World of Quality, ASQ Lynchburg, VA Section, May 2013
  • Owens, T; Keathley, J; Innovation Live!; WCQI 2013, Indianapolis, IN
  • Keathley, J; Role Ahead: The Innovation Manager, ASQ Blue Ridge Section, November 2012, Waynesboro, VA
  • Keathley, J; Performance Outcomes Designed for Innovation; SPQA 2012 Virginia Forum for Excellence, Richmond, VA
  • Owens, T; Merrill, P; Niles, K; Keathley, J; Innovation Live!; Institute for Continual Quality Improvement  Annual Conference 2012, Anaheim, CA
  • Keathley, J; Transition Pathways: Quality to Innovation; ASQ Quality Management Division and Toronto Section, Joint Meeting, April 2012, Toronto, Ontario, Canada
  • Keathley, J; Role Ahead: The Innovation Manager; ISO9000 2012 International Conference, February 2012, Orlando FL
  • Keathley, J; Innovation: A Driver for Value Creation; Project Management Institute, Charlottesville Chapter, November 2011 meeting
  • Keathley, J; Role Ahead: the Innovation Manager; WCQI 2011, Pittsburgh, PA
  • Keathley, J; Innovation and the Quality Manager of the Future; Institute for Continual Quality Improvement 2011, Pittsburgh, PA; Quality Management Division Forum 2011, Orlando, FL; and Quality Expo, 2011, Chicago IL
  • Keathley, J and Owens, T; Putting Quality Tools to Work for Innovation; WCQI 2010, St. Louis, MO 
  • Keathley, J; Innovation as a Planned Performance Outcome; WCQI 2010, St. Louis, MO

Technical and Regulatory Documents

  • Quality System Manuals, Processes, Work Instructions
  • Quality and Business Policies
  • Training Materials and Presentations
  • Product Technical Brochures
  • Product Regulatory Descriptions
  • Study Protocols
  • Clinical Statistical Study Reports
  • Regulatory Submission Summaries
  • Risk Benefit Analyses