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Conducting Effective Investigations Workshop“You can’t solve a problem by using the same thinking as used when you created it”
Einstein
Using interactive case studies, participants learn how to conduct and document effective investigations into deviations, OOS results and non-conforming events. Using puzzle-solving approach and interactive methods, the facilitator will demonstrate to participants how every incident has cause(s) which can be found and corrected.
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Issues to be covered
- Two days on site with break-out groups each morning and afternoon
- Investigating the timeline
- Break out #1: case study of different event description
- Documenting the event
- Storyboard
- Break out #2: Case study alone and then same case study in teams
- Facts vs Hypothesis
- Brainstorming: Open – mind and then focusing using RCA Root Cause Analysis
- Moving beyond Human Error and Train / ReTrain
- Break out #3: Case study in teams
- Break out #4: Concise and Precise report writing (with / without ChatGPT)
Who should attend
This workshop is suitable for:
- Operations, manufacturing, engineering and maintenance, purchasing / procurement
- HR personnel will benefit particularly from understanding human factors in the cause of errors and in conducting investigations
- API / Drug Substance and non-sterile Finished / Drug Product manufacturers
- R&D, Technology Transfer, QC / Microbiology laboratory personnel
- Clinical trials, regulatory affairs, and manufacture, testing and oversight of microbial aspects of Investigational Medicinal Products will also find the course very useful.
Benefits to the Participants
At the end of this two-day workshop participants should be able to:
- Accurately document an unwanted event
- Manage an investigation team
- Storyboard the investigation
- Create a timeline: before, during, after the event
- Use root cause analysis as an effective investigation tool
About The Lecturer
