By the end of this lesson, you'll be ...

LEARNING OUTCOMES

  • Understanding the full context

    Including both compliance and agile processes

  • Familiar with regulatory standards

    With insights how FDA and others deal with agility

  • Aware of regulatory challenges

    With key points to address when applying agile

What's included

  • 5 videos with introduction and expert instruction

  • 4 quizzes / assignments

  • Virtual sticky notes with takeaways

  • Social community and lesson discussions

  • Lesson toolbox with learning resources and freebies

  • Digital lesson completion badge

Meet your facilitator

Hey I'm Bruce, an Agile Way of Working coach and trainer from The Netherlands. I have helped 200+ organizations with transformational change and learning to unleash value, flow, agility and people's potential. My background includes an MSc in Engineering, a track record at Microsoft and a SAFe SPC6 certification. Enjoy real-world learning experiences in these lessons!

Bruce Schoor

Agile Way of Working Coach

Lesson outline

  • 01

    Lesson introduction

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

Suggested to learn before

LEARNING PATH

Learning paths that contain this lesson

Pricing options

View pricing options in the parent e-course.

What people say

“It was indeed very good. I had a wonderful learning experience. I will definitely recommend it to others.”

Jogesh G.

Manager HR & Operations, Blum Group

“We are very satisfied with the training, all the feedback reflected it.”

Katinka H.

Change Program Manager, NNG

“I enjoyed the training, the first module was very inspiring.”

Maaike V.

Talent & HR Manager, Akvo

FAQ

  • What to do if I have questions?

    You'll be able to post and discuss your question in the built-in community discussion forums. For any questions before you buy, you can contact us at [email protected].

  • How long do I have access to the lesson?

    You receive lifelong access so that you can learn at your own pace. And after you complete the lesson, you'll be able to come back and review all content at any point.

  • Do I receive a certification?

    You receive a Digital Lesson Completion Badge upon finishing the lesson. For courses (collections of lessons), we issue Agile Professional Certifications.

Suggested to learn after

LEARNING PATH

Memberships

ADDITIONAL PRICING OPTIONS

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