Welcome to Deviation Investigations and Investigation Report Writing, an advanced CGMP training course.
Deviation Investigations
The CGMP Require in Sec. 211.100 (b) Written procedures; deviations. (b) Any deviation from the written procedures shall be recorded and justified.
Learn to use the most effective tools to investigate a plant, laboratory or customer service deviation.
Presentations cover the following topics:
![Image of a Deviation Investigation Team](https://skillsplusinc.com/wp-content/uploads/2021/07/austin-distel-wD1LRb9OeEo-unsplash-230pxls-1-1024x769.png)
- Introduction to Root Cause Analysis
- Deviation Investigation Terms
- Interviewing and Path Forward
- Root Cause Analysis: Fish Bone Diagrams
- Five Why’s Mapping
- Distinctions
- Walk-Through-Analysis
- Change Analysis
- Understanding Human Errors
- Control Barrier Analysis
- Determine Product Impact
- Research Previous Investigations
- Immediate Actions and Containment
- Corrections
- Corrective Actions
- Preventive Actions
- Follow up and CAPA Effectiveness Checks
- Risk Assessment
Email us or give us a call to discuss your training needs. Simply contact us!
![Image of an old fashioned typewriter with paper indicating "Investigation".](https://skillsplusinc.com/wp-content/uploads/2021/07/markus-winkler-cS2eQHB7wE4-unsplash-230pxls-300x200.png)
Deviation Investigation Report Writing
Learn to write deviation investigation reports that meet the needs of the company, quality assurance and the FDA.
Presentations cover the following topics:
- Introduction to Deviation Report Writing
- Writing Tips
- Description of the Event
- Event Classification
- Immediate Actions and Containment
- Previous Investigation Summaries
- The Sequence of Events
- Root Cause Summary
- Product Impact
- Corrective and Preventive Actions
- Report Follow UP Actions and Effectiveness Checks
- The Proper Use of Background Information
- Using Attachments
- Referential Information
- Interim Reports and Deviation Extensions
Email us or give us a call to discuss your training needs. Simply contact us!
One-on-one personal coaching is provided on the use of each tool or section of the deviation investigation report. Coaching builds and reinforces skills.
How this course works on-line
- Employees view a presentation authored and presented by a seasoned deviation investigator.
- Employees complete the associated worksheet apply to an actual in-your-plant deviation the tool or report section just discussed. (non disclosures will be signed ahead of enrollment).
- A seasoned investigator will review the employee’s work and email to the employees specific comments addressing what work is a good representation of the tool and other areas to consider in the investigation process, including clarification of CGMP regulations impacting the deviation being investigated.
- When the instructor has passed the employee on a particular tool, then the employee is encouraged to move on to the next topic.
- Online internet-based e-learning, is designed to fit your schedule, 365 x 24 x 7. Come and go as needed. What is e-learning? Therefore, our courses are convenient and flexible.
- Above all, if you have questions, please e-mail us for the fastest response at jennifer.payne@skillsplusinc.com
Optional course for more in depth CGMP Understanding
- If you need more in depth CGMP understanding, we encourage the employee to sign up for The New Generation Series.