How to Manage Deviations in a GMP Environment – Part 2
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 4: Deviation Archiving, Storage and Review
| Definition archiving | 1 min 23 secs |
| Step 1: Identify the types | 1 min 52 secs |
| Step 2: Identify the information | 58 secs |
| Step 3: Document the CAPA | 1 min 30 secs |
| Definition archiving summary | 1 min 15 secs |
| Deviation storage | 1 min 23 secs |
| Storage space | 1 min 19 secs |
| Storage method | 1 min 22 secs |
| Storage conditions | 48 secs |
| Deviation review | 1 min 09 secs |
| System review and repetitive pattern analysis | 1 min 33 secs |
| Trend and result analysis – Part 1 | 52 secs |
| Trend and result analysis – Part 2 | 1 min 10 secs |
| Strategic solution | 1 min 45 secs |
| Management review | 1 min 05 secs |
Module 5: Deviation Closure
| Steps for deviation closure | 1 min 12 secs |
| Deviation closure documentation | 1 min 20 secs |
| Bullet proof deviation prevention | 45 secs |
Module 6: Suggestion for Case Specific Deviation Handling
| Industry deviations | 1 min 29 secs |
| Sales and customer related deviations | 1 min 17 secs |
| Service related | 1 min 37 secs |
| Product related | 1 min 07 secs |
Module 7: Deviation Examples
| Let’s set the scene | 1 min 10 secs |
| Receiving the deviation | 1 min 20 secs |
| Handling the deviation | 1 min 33 secs |
| Corrective and preventative action | 1 min 23 secs |
| Deviation communication | 1 min 40 secs |
| Deviation closure | 1 min 44 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:
General Info:
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CEU Credits: 0.1 -
Course code: ELM-131 -
Duration: 45 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
The most comprehensive course out there on deviations in a GMP environment.
A must do course for anyone who works in the life sciences in all areas of the business.
We’ve incorporate this course a must-do for new hires and refresher training.
If you work in a regulated environment you must understand the importance of deviations – This course will tell you all you need to know.
Related courses:
How to Manage Deviations in a GMP Environment – Part 1
Laboratory Investigations & Deviations
21 CFR Part 820 Subpart G – Production and Process Controls
An Introduction to Cleaning Validation
How to Prepare for Internal & External Laboratory Audits
How to be an Effective GMP Auditor – Part 1
How to be an Effective GMP Auditor – Part 2
How To Be An Effective GMP Auditor – Part 3
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