How to Manage Deviations in a GMP Environment – Part 1
Description:
This course has been designed to explain how to manage deviation in a regulated environment. By taking this course, you will learn how to identify deviations, how to train your personnel on deviation management, how to keep your deviations up-to-date,how to communicate all the necessary deviations with your colleagues and also How to close a deviation.
Curriculum for this course:
Introduction
| Overview | 1 min 10 secs |
| Learning objectives | 1 min 13 secs |
| Who should take this course? | 50 secs |
| Course modules | 45 secs |
Module 1: Regulatory Requirements
| Definition of a deviation | 1 min 15 secs |
| Examples of deviations | 1 min 52 secs |
| EU – EudraLex | 1 min 19 secs |
| US FDA | 1 min 41 secs |
| Systematic approach | 1 min 57 secs |
Module 2: Prerequisites to Implementing Deviation Management
| Deviation management procedure | 1 min 30 secs |
| Who will issue the deviation? | 1 min 43 secs |
| Who will handle the deviation? | 45 secs |
| Allowed time to report a deviation? | 1 min 23 secs |
| Required information in the deviation description | 1 min 40 secs |
| Deviation entry and sequencing | 59 secs |
| Categorization of the deviation | 1 min 34 secs |
| Incident deviations | 1 min 55 secs |
| Minor deviation | 1 min 20 secs |
| Major deviation | 58 secs |
| Critical | 1 min 17 secs |
| Method used for root cause analysis | 1 min 16 secs |
| Corrective and Preventive Actions (CAPAs) | 1 min 20 secs |
| Short term actions | 1 min 18 secs |
| Long term actions | 1 min 50 secs |
| Short Vs long term actions | 47 secs |
| Personnel | 50 secs |
| Level 1: Identifying deviations and reporting them | 1 min 05 secs |
| Level 2: Deviation handling and investigating | 1 min 07 secs |
| Level 3: Deviation corrective and preventive actions | 1 min 22 secs |
| Optional training sessions | 1 min 19 secs |
Module 3: Deviation Communications
| Deviation report | 1 min 07 secs |
| Communicating within the quality assurance department | 1 min 13 secs |
| Communicating deviations within an organization – Part 1 | 1 min 19 secs |
| Communicating deviations within an organization – Part 2 | 1 min 24 secs |
Conclusion
Final Assessment
Certification
Revision History
| Redesigned course with new Articulate Storyline player | V2.0 |
| Added new final exam question to align with learning objectives | V2.0 |
| Updated Glossary links | V2.0 |
Author:
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General Info:
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CEU Credits: 0.1 -
Course code: ELM-129 -
Duration: 45 mins -
Skill Level: Basic -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
Very comprehensive course on all things deviation related.
This course really helped me understand the life cycle of a deviation and its importance.
A must do course for anyone working in a regulated environment.
Make this course part of your induction program today!
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