Medical Device Risk Management

DAY ONE

8:00 a.m. – 9:00 a.m.

Registration/Continental Breakfast

9:00 a.m. – 12:00 p.m.

  • Training — a cost or 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
  • Regulatory expectations for training
    • Expectations — what they are and where they come from
    • INTERACTIVE EXERCISE! Specific training-related expectations from authorities in the U.S., Canada, EU, PIC/S and WHO
  • Compliance failures and training — identifying the causes
    • Where firms have fallen short of the expectations
    • Recent citations for inadequate training
    • Root and contributing causes of training failures
  • Training is not the answer to all your problems
    • INTERACTIVE EXERCISE! Ways to waste time, money and opportunity through training
    • Thinking about performance solutions in your CAPAs, not just training
    • Knowledge in the head, knowledge in the world or both?
  • Competency-based training
    • What is it?
    • How it differs from more traditional types of training

12:00 p.m. – 1:00 p.m.

LUNCH

1:00 p.m. – 4:00 p.m.

  • A quick look at learning theories: how we learn
    • INTERACTIVE EXERCISE! Characteristics of the learning theories and what they mean for trainers
  • Building a successful training program
  • Learning plans or curricula
    • How they are used
    • Benefits
  • Considering the learners as part of the training solution
    • Characteristics of adult learners
    • The learners of today and the learners of tomorrow
  • What qualifies a trainer?
  • Approaches used to design and develop training courses
    • ADDIE (Analysis, Design, Development, Implementation and Evaluation)
    • Rapid Prototyping
    • A detailed look at the fives phases of the ADDIE model
    • Writing active learning objectives for your courses
    • Working with subject matter experts — SMEs
    • INTERACTIVE EXERCISE! Case study: How could you make this better?
  • Authentic learning — matching learning methods to the job to increase success
    • INTERACTIVE EXERCISE! Creating an authentic activity

 

DAY TWO

8:00 a.m. – 8:30 a.m.

Continental Breakfast/Networking

8:30 a.m. – 12:00 p.m.

  • INTERACTIVE EXERCISE! Keys to a successful training system – quick review
  • Assessment and evaluation — how can you measure success?
    • Formative or summative – what are the differences?
    • The Kirkpatrick and Philips models
    • What about return on investment?
    • How far do you go?
    • INTERACTIVE EXERCISE! What would evaluation and assessment look like for this course?
  • Alignment: Making sure all the pieces fit
  • What is “alignment”? Why is it so important?
  • Other ways to get people involved
  • The connection between training and procedures
    • Why are there failures in following procedures? Is it always training?
    • INTERACTIVE EXERCISE! The amount of detail in a procedure
    • Ways to promote consistent performance using an SOP
    • Use of job aids

12:00 p.m. – 1:00 p.m.

LUNCH

1:00 p.m. – 4:00 p.m.

  • eLearning — ways to contribute to its success
  • Virtual learning – what’s out there?
  • Evidence of training and performance
    • Training records
    • Learning Management Systems (LMSs) and their use — what will
      work for you?
  • A new dimension for training: the conative domain
    • What is it?
    • Why is it important?
    • How can it be enhanced?
    • INTERACTIVE EXERCISE! Evaluating and enhancing YOUR training program
    • What metrics are you using?
    • What are some ways it can be improved?
    • Making the case to management to support and enhance training