FDA QSR 21 CFR Part 820 Foundation Training

Following the FDA’s recent QSR remodeling proposal to align the current requirements to ISO 13485, this course will explore in detail the relationship between ISO 13485 and FDA Quality System Regulation requirements.

Curriculum10 - 16 hours

Getting Started
Module 0: Introduction
Module 1: Introduction to FDA QSR & ISO 13485
Module 2: Establishing a QMS
Module 3: Management Responsibility
Module 4: Resource Management
Module 5: Product Realization Part 1
Module 6: Product Realization Part 2
Module 7: Measurement, Analysis and Improvement
ISO 13485 + FDA QSR Final Exam
Conclusion

Curriculum10 - 16 hours

Getting Started
Module 0: Introduction
Module 1: Introduction to FDA QSR & ISO 13485
Module 2: Establishing a QMS
Module 3: Management Responsibility
Module 4: Resource Management
Module 5: Product Realization Part 1
Module 6: Product Realization Part 2
Module 7: Measurement, Analysis and Improvement
ISO 13485 + FDA QSR Final Exam
Conclusion