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
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