Laboratory Data Integrity and the Principles of ALCOA
Description:
It is critical that the data generated in a regulated laboratory is accurate and trustworthy. This certified course provides the necessary knowledge and skills to ensure that attendees are able to fully integrate data integrity into laboratory quality management systems, thus ensuring that all scientific data delivered by analytical testing laboratories is both reliable and trustworthy.
Curriculum for this course:
Introduction
Overview | 40 secs |
Learning objectives | 1 min 23 secs |
Who should take this course? | 46 secs |
What is laboratory data integrity? | 35 secs |
Module Oveview | 1 min 30 secs |
Module 1: Practices that Undermine the Integrity of Laboratory Data
Overview | 17 secs |
Able Laboratories Scandal 2005 | 1 min 33 secs |
Leiner Health Products 2007 | 2 min 12 secs |
The practice of analysing ‘unofficial’, ‘trial’ or ‘demo’ samples 2006 – 2014 | 53 secs |
The Case of Annie Dookham and the Massachusetts Forensic Drug Laboratory | 1 min 31 secs |
Summary | 2 min 06 secs |
Review activity | 50 secs |
Module 2: Consequences
Overview | 1 min 40 secs |
Consequences of the client customer or patient | 34 secs |
Consequences for the laboratory or organisation | 30 secs |
Consequences for the laboratory staff and management | 15 secs |
Review activity | 24 secs |
Module 3: Assuring the Integrity of Laboratory Data
Overview | 27 secs |
How can an analytical process be manipulated? | 35 secs |
Requirements to assure the integrity of laboratory records | 54 secs |
Legible and understandable | 46 secs |
Attributable | 34 secs |
Contemporaneous | 1 min 11 secs |
Original | 57 secs |
Accurate | 1 min 18 secs |
Complete | 1 min 45 secs |
Consistent | 1 min 15 secs |
Indelible | 45 secs |
Available | 50 secs |
Assuring the integrity of electronic records | 1 min |
Controls and safeguards | 1 min 10 secs |
Restricting access | 1 min 15 secs |
Establish access controls | 45 secs |
User privileges | 2 min 15 secs |
Audit trails | 55 secs |
User training and user records | 30 secs |
Administrative controls | 1 min 30 secs |
Review activity | 1 min |
Module 4: Identifying Unreliable Laboratory Data
Overview | 2 mins |
Analytical process | 2 min 20 secs |
Mobile phase | 1 min 05 secs |
Confirming the integrity of analytical results | 55 secs |
Suitability solutions | 1 min 50 secs |
Confirming the integrity of analytical results | 1 min 05 secs |
Sample preparation | 1 min 35 secs |
Confirming the integrity of analytical results | 1 min 56 secs |
Integration peaks | 1 min 45 secs |
Confirming the integrity of analytical results | 1 min 15 secs |
Review activity | 2 mins |
Conclusion
Final Assessment
Certification
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