Good Manufacturing Practices (cGMP) - Advanced

Elevating Quality Culture through Positive Behaviors

Elevating Quality Culture Through Positive Behaviors brings quality culture to life. In GxP environments, where the stakes are high and the consequences of failure can be severe, quality is essential. Through the story of Casey, a young boy impacted by contaminated eye drops, learners explore the critical role of individual behavior in quality culture. This course dives into Quality Maturity Management (QMM) and provides actionable steps for life science professionals to drive meaningful improvements.

CEU Credits: 0.1
Course Code: ELM-120
Duration: 20 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V3.1
Effective Date: 04/24/2024

Curriculum for this course

Course Introduction
Quality Culture
Quality Culture Defined
What Can You Do?
Employee Guidelines
Key Ingredients for Meaningful Improvements
Case Studies
May 2019 Warning Letter
What is QMM?
A Three Step Approach
The 4 Elements of QMM
August 2019 Warning Letter
Changing Behaviors

Conclusion

Test Your Knowledge

v3.1 Minor update on 09/11/2024 to fix a typo and ensure all quiz feedback is visible.
v3.0 Major update on 04/24/2024 to remove an archived FDA report and replace it with Quality Management Maturity as a key discussion topic.
v2.0 Major update on 09/22/2023. This course has been redesigned. The previous course title was Behavioural Based Quality (BBQ) for a GMP Environment. As part of the redesign, this course’s new name is Elevating Quality Culture through Positive Behaviors.
v1.0 Course released on 04/21/2022

Author

Peter Alcocer

Director of eLearning Compliance

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