Laboratory Data Integrity and the Principles of ALCOA

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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