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Lesson outline

  • 01

    Lesson introduction

    • L2 0 Conforming to 21 CFR 820 QSR while being agile - introduction (video)
  • 02

    Quality System Regulations and QMS

    • L2 1 Quality System Regulations and QMS (video)

    • L2 1 Quality System Regulations and QMS (slides)

    • L2 1 Quality System Regulations and QMS (quiz)
  • 03

    FDA QSR subsystems

    • L2 2 FDA QSR subsystems (video)

    • L2 2 FDA QSR subsystems (slides)

    • L2 2 FDA QSR subsystems (quiz)
  • 04

    Design controls

    • L2 3 Design controls (video)

    • L2 3 Design controls (slides)

    • L2 3 Design controls (quiz)
  • 05

    Using design controls in an agile SDLC

    • L2 4 Using design controls in an agile SDLC (video)

    • L2 4 Using design controls in an agile SDLC (slides)

    • L2 4 Using design controls in an agile SDLC (quiz)
  • 06

    Lesson takeaways

    • L2 9 Conforming to 21 CFR 820 QSR while being agile - takeaways (slides)
  • 07

    Resources

    • Resources