Approved training courses

Course description

Data Integrity is currently a MAJOR focus area during regulatory inspections. It is therefore essential that your team have the correct understanding of what is required. This online data integrity course covers the background to Data Integrity, why it is important and how its requirements affect both paper-based and computer-based systems. This 20-minute online data integrity course will give you and your team a clear understanding of your role in meeting the expectations of EU Inspectors (such as the UK’s MHRA) and the FDA.

Who will the course benefit?

This online Data Integrity course is aimed at new starters and existing staff as part of their ongoing Data Integrity training. It delivers a practical overview of the threats and issues posed within paper-based, electronic and hybrid systems. Trainees will finish the course with an understanding of how Data Integrity impacts on their day to day role and how to comply with regulatory expectations. Trainees simply login and start learning, wherever and whenever they like!

Course overview
Delegates will learn about Data Integrity threats and issues posed by paper, electronic and hybrid systems and how to comply with regulatory requirements. Delegates will leave the course with a clear understanding of the current expectations of EU Inspectors (such as the UK’s MHRA) and the FDA.

Duration:
The online data integrity course takes around 20 minutes to complete including the assessment .

Course content
What is Data Integrity?
Why it is important
The ALCOA principles, for: Paper-based, computer-based and hybrid systems
online Data Integrity training
Application of the ALCOA Principles
The importance of metadata
Positive Quality Culture
Assessment

Assessment and certificates:
At the end of the online data integrity course there is a series of randomly selected assessment quiz questions. An 80% pass mark is expected to successfully complete the course. Guidance is provided if a delegate gets an answer wrong. After successful completion of the course, a certificate is available for download by the learner and/or the team administrator.

The benefits of this programme?
Accessed over the internet using desktop computers, laptops, tablets, and smartphones
Or available for access via your own internal systems
Aimed at new starters, existing staff and as part of ongoing Data Integrity training
Authored by specialists in the field of Data Integrity who can provide you with additional implementation support, if required
The course provides an overview of DI threats and issued posed within paper, electronic and hybrid
It delivers a consistent message to facilitate building a positive Data Integrity culture
At the end of the course assessment ‘quiz questions’ evaluate the learner’s knowledge
Upon successful completion, a certificate is available for download by the trainee and/or the team administrators
It’s simple, flexible and very cost effective

Pre-requisites

Internet access is required.

Additional info

The cost of £450 is for 10 learners. Group discounts are available.

Training provider

Inspired Pharma Training

Email

info@inspiredpharma.com

Tel

+44 1635 866699