Beyond GMP Training


Beyond GMP Training

Bethesda, MD • March 19-20, 2014




8:00 a.m. – 9:00 a.m.


9:00 a.m. – 12:00 p.m.

  • Training — a cost or an investment?
    • The state of training in our industry and beyond
    • The connections between training, quality and other benefits
    • Is yours a learning or a training organization?
  • INTERACTIVE EXERCISE! Issues affecting training programs today — Identifying deficiencies that can reduce the effectiveness of training.
  • Regulatory expectations for training and deviation investigations related to human errors
    • Expectations — what they are and where they come from
    • Examples of training and investigation-related expectations from US, Canada, EU and WHO for the pharma and device industry
  • Compliance failures — identifying the causes
    • Where firms have fallen short of the expectations
    • Recent citations for inadequate training
    • Recent citations for inadequate investigation into “human errors”
    • Root and contributing causes: Why?
  • Training is not the answer to all your problems
  • INTERACTIVE EXERCISE! Ways to waste time, money and opportunity through training — Finding real-life examples of where training hasn’t had the impact that it was supposed to have.
  • Thinking about performance solutions in your CAPAs, not just training
  • Knowledge in the head, knowledge in the world, or both?

12:00 p.m. – 1:00 p.m.


1:00 p.m. – 4:00 p.m.

Models for investigating accidents and incidents

  • Case study: The case of Flight 5191
    • Going beyond the category of “human error”
    • INTERACTIVE ACTIVITY! Where were the errors? — With a model to further define human error, identify potential causes of the crash of Flight 5191.
  • How we (unintentionally) contribute to mistakes
    • Why we make mistakes
    • “Error traps” that can ensnare even the best
    • Hazards of “black box” technology
    • Hierarchies and silos as barriers
    • Why even experts make mistakes
  • Why not? Simple, effective ways to increase learning, share knowledge and reduce mistakes
    • Risk assessment and risk management
    • After-action reviews
    • Don’t defy gravity
    • Pre-action visualizations
    • Technological tools
    • Job and performance supports
  • What can we learn from other industries?
    • Aviation
    • Healthcare delivery
    • Nuclear power


8:00 a.m. – 8:30 a.m.


8:30 a.m. – 12:00 p.m.

  • INTERACTIVE EXERCISE! A quick review — Discuss what you and your team-mates found useful from the previous day and ways you can apply the ideas.
  • Procedures as tools to support performance
  • INTERACTIVE EXERCISE! The amount of detail in a procedure
    • Ways to promote consistent performance using an SOP
  • Case studies: What could we do?
  • INTERACTIVE EXERCISE! Identifying integrated approaches to solve problems using supplied cases or “bring-your-own” — A chance to apply the models and find could have caused or contributed to the problem. (If you have a problem you are working on, bring a “disguised” version of it as a case your team can consider.)

12:00 p.m. – 1:00 p.m.


1:00 p.m. – 3:30 p.m.

  • Assessment and evaluation — how can you measure success?
    • What can your quality system tell you about the effectiveness of your learning program?
    • INTERACTIVE EXERCISE! What would evaluation and assessment look like for this course? — Come up with ways to evaluate the course and assess individual learning – models that you can take back and use
  • Alignment: Making sure all the pieces fit
    • What is “alignment?” Why is it so important?
  • Evaluating and enhancing YOUR learning program and investigation program
    • What metrics are you using?
    • INTERACTIVE EXERCISE! What are some ways they can be improved? — Create an action plan that you can use to improve your learning and performance program.
    • Making the case to management to support and enhance training, improve investigations and drive down human errors

3:30 p.m. – 4:00 p.m.