Human Error: Cause or Consequence? - Online Training Recording
Course No. 23331
Speakers
Sue Mann
Sue Mann Consultancy
Highlights:
- Background and Regulatory Expectations - Rethinking “Human Error” – From Blame to System Thinking - Practical Case Examples
Target Group
This online training course is designed for professionals involved in evaluating and improving GMP compliance, including QPs and auditors.
Objectives
This online Training course aims to strengthen participants’ ability to differentiate between apparent human error and true root causes in GMP-relevant deviations. The objective is to enhance investigation quality, avoid premature attribution to “human error,” and ensure that process-, procedural-, or system-related deficiencies are appropriately identified and addressed.
Human error cannot be completely avoided. However, issues that initially appear to be caused by human error should always be explored further. In most cases, human error is not the true root cause of a non-conformance but rather a consequence of an underlying systemic weakness. Nevertheless, the pharmaceutical industry still seems to struggle with recognising and correctly addressing the different types of human error and their true causes, while regulators tend to regard human error only as a last resort. Chapter 1 of the EU GMP Guidelines (1.4, xiv) states: “Where human error is suspected or identified as the cause, this should be justified, having taken care to ensure that process-, procedural- or system-based errors or problems have not been overlooked…”.
Programme
Part 1: What is behind “Human Error”?
Why do we have human error?
Humans are not machines
Human error rates – what is acceptable?
Why human error could not be a root cause
Is human error avoidable?
Part 2: Examples for deeper Understanding Analyse real-life scenarios and identify typical investigation weaknesses. Gain practical tips to reduce human error through process design, environment, and system improvements – instead of relying on retraining alone.
Further Information
Technical Details To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your Needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Fees (per delegate plus VAT) Non-ECA Members EUR 690 ECA Members EUR 590 APIC Members EUR 640 EU GMP Inspectorates EUR 590.- The conference fee is payable in advance after receipt of invoice. VAT is reclaimable.
Conference language The official conference language will be English.
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