Good Pharmacovigilance Practices (GVP)

Recalls and Consent Decrees

This course explores the regulatory actions of recalls and consent decrees, their consequences, and the roles that manage them.  Through case studies, learners will understand their complexities and the steps necessary to prevent such crises.

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CEU Credits: 0.1
Course Code: ELM-960
Duration: 20 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0
Effective Date: 07/24/2024

Curriculum for this course

Things Fall Apart
What is a Recall?
Global Recall Similarities and Differences
Recall Levels
Roles
Consequences of Recalls
A Recall Story. Chapter 1: How Deep?
A Recall Story. Chapter 2: Getting the Word Out
A Recall Story. Chapter 3: Everybody’s In
A Recall Story. Chapter 4: What Should Have Happened
A Recall Story. Chapter 5: Withdraw From The Market
A Recall Story. Chapter 6: An Unhappy Ending
What is a Consent Decree?
Global Analogs
Consequences of Consent Decrees
Falling Into A Consent Decree
Life Under Consent Decree
Recall Readiness
Ducks In A Row
Test your Knowledge!

Author

Matt Peplowski

Owner & Principal, Biopharm Error Prevention Associates, Inc.

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