Contamination Control & Aseptic Techniques

How Deviations (Non-Conformance’s) Should be Handled from a Regulatory Perspective

This course focuses on defining the term deviation (nonconformance) and further discusses the expectations of the regulatory bodies in the United States and Europe. The purpose of this course is to provide a general understanding of deviations and how they should be handled when they occur.

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CEU Credits: 0.1
Course Code: ELM-712
Duration: 30 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0

Curriculum for this course

Overview
1 min 01 secs
Learning Objectives
58 secs
Who Should Take This Course?
1 min 08 secs
Deviation (Nonconformance) Definition
1 min 15 secs
Examples of Deviations
1 min 23 secs
Eudralex: Chapter 1.4, IX
35 secs
Eudralex: Chapter 1.8, VII
29 secs
Eudralex: Chapter 1.10, IV
31 secs
Eudralex: Chapter 4, Quality Control, 4.29
38 secs
Eudralex: Chapter 5, Production, 5.15
25 secs
Eudralex: Chapter 5, Production, 5.44
21 secs
Eudralex: Chapter 6, Quality Control, 6.33
30 secs
FDA: Section 211.100 Written Procedures; Deviations
1 min 01 secs
FDA: Section 211.160 General Requirements
38 secs
FDA: Section 211.111 Time Limitations on Production
31 secs
Systematic Approach Overview
1 min 10 secs

Conclusion

Final Exam

Certification

Author

Graham O'Keeffe

General Manager - Veeva LearnGxP

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