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Conducting Effective Investigations
Almost every regulatory inspection starts with a pre-inspection request for a list of non-conformances: deviations, OOS results, changes, incidents, non-conforming product, returns, recalls, complaints… this list is long
If it is agreed that the primary purpose of a Quality Management System is to #PREVENT unwanted, undesirable, unexpected events, then any non-conformance is of concern.
Some events are...Continue reading
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Issues to be covered
- What is a non-conforming event: deviation, OOS, Complaint, or any other identified deficiency in a quality system
- PREVENTION
- Correction
- Corrective Action
- Investigations:
- When are they NOT needed
- How to conduct an investigation
- How to document an investigation
- Conclusions as opposed to findings (facts)
- Communication
- Change management for Corrective Action
- Escalation process and management involvement (SOP) for resolving tough issues
Who should attend
VP Operations, Production Managers, Quality Unit Directors, VP Quality, VP QA / RA, Quality Unit Supervisors, RA personnel, personnel involved in product development, Operations and Production personnel and Supervisors, Laboratory personnel and any other person involved directly or indirectly in compliance and quality related activities.
Benefits to the Participants
- Understand which type of events require investigation
- Differentiate between investigation of:
- Product Impact
- Cause(s) of the event to eliminate the cause and ensure it does not recur
- Learn how to document the investigation effectively
- Monitoring effectiveness
- Communication of findings, lessons learne
- Change control for corrective actions
About The Lecturer
