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Course Agenda
Day One (8:30AM - 5:00PM)

8:00 – 8:30 AM: Registration

8:30 – 10:00 AM:  What is Quality?
  • Quality, quality system, and GMP terms
  • Medical Device quality and quality systems

10:00 – 10:15 AM: Break

10:15 AM – 12:00 noon:  What is Quality (continued)
  • Quality Myths and Barriers to Quality
  • Quality system implementation and improvement

11:00 – 11:30 AM: Group exercise: Quality system design

12:00 noon – 1:00 PM: Lunch

1:00 – 2:30 PM: What is Regulatory Compliance?
  • Regulatory compliance terms, organization and roles
  • Medical Device laws, regulations, directives, standards, and guidance



2:30 – 2:45 PM: Break

2:45 – 5:00 PM: What is Regulatory Compliance (continued)
  • What is a medical device?
  • Medical Device Types
  • Medical Device Classification

2:45 – 3:15 PM: Group exercise: Medical Device Classification Exercise
Day Two (8:30 AM - 5:00PM)

8:30 – 10:00AM: FDA and EU Regulatory Compliance
  • What is the FDA and EU?
  • Similarities and differences between the FDA and EU philosophies, quality systems, and enforcement

10:00 – 10:15AM: Break

10:15 – 12:00 noon: FDA and EU Regulatory Compliance (continued)
  • FDA QSIT (Quality System Inspection Technique)
  • FDA website walk-through

11:00  – 11:30 AM: Group exercise: FDA Regulatory Exercise

12:00 noon – 1:00 PM: Lunch

1:00 – 2:30 PM: Quality Audits
  • What is quality auditing?
  • Three types of medical device quality audits
  • Do’s and Don’t of quality auditing

2:15 – 2:30PM: Break

2:30 – 5:00 PM: Quality Audits (continued)
  • Similarities and differences between FDA inspections and investigations and EU Notified Body audits
  • FDA Enforcement, Warning Letters, and Trends

4:30 – 5:00 PM: Group exercise: FDA Compliance Exercise