An online Data Integrity course to ensure your team understand their role in meeting the expectations of EU Inspectors and the FDA regarding Data Integrity threats and issues
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.
Use these links to navigate around this page:
Make a Booking
To make a booking for you and your team use the panel below:
Up to 10 learners
On our online platform
£450 plus VAT for 2 months access
Up to 25 learners
On our online platform
£999 plus VAT for 2 months access
PLEASE NOTE: When you make a booking only enter your name and do not add the names of the other team members. For details of how the online learning works and what will happen once you make a booking click on the tab below ‘Using our online system’ describing this area in more detail.
Prices exclude UK Value Added Tax (VAT) at 20% which will also be charged for UK based delegates. VAT will not be charged for delegates from outside of the European Union (EU) or for delegates from within the EU if they supply their company’s VAT number when booking.
If you plan to pay by credit card then you should first look at this helpful information.
To find out more about our online data integrity course click on the tabs below or to try a free Taster course subscribe by clicking on the link in blue in this sentence.
There is also a one-day public course if you need a full understanding in this area – click here for more details.
Key Course Information
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!
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.
The online data integrity course takes around 20 minutes to complete including the assessment .
- What is Data Integrity?
- Why it is important
- The ALCOA principles, for: Paper-based, computer-based and hybrid systems
- Application of the ALCOA Principles
- The importance of metadata
- Positive Quality Culture
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.
Purchasing options and details
Use our online system
Learners simply need their desktop pc, a laptop, a tablet or even a smartphone and access to the internet to undertake this 20-minute online Data Integrity course.This will enable them to access the course ANYTIME ANYWHERE.
Learners have 2 months to complete the course :
Learners will have access to the online data integrity course for a 2-month period from their registration onto the course by the Team Administrator. If they do not complete the course within this time then you will need to pay again to complete the course or if you have an unused license you may use this. A certificate is only issued once the course is completed in full
Groups up to 50
You can use the buttons in the panel above to purchase multiple licenses for up to 50 learners. For example, if you have 15 learners in your team purchase the 10-license option twice. If you have 35 learners purchase the 10-license option and the 25-license option. Once we have received your payment we will set up your team in our system and also a team administrator (you or someone you nominate). The team administrator will then add your learners up to the maximum number you have purchased. They will then be able to see their learners progress and print certificates from the system for their own internal records. To undertake these activities the team administrator will be sent links to relevant parts of the Help system. If they have any questions the team administrator will be able to contact our support team via email.
The process for larger groups is exactly as described above except that you should contact us to outline your requirements and questions. We will provide you with a quote and if you decide to go ahead send you an invoice.
Or use internally
If you are interested in purchasing the online data integrity course materials on an annual license for use on your own Learning Management Systems (LMS) then please contact us to discuss options.
The courseware is available in the following formats: SCORM 1.2, SCORM 2004, AICC and the Tin Can API.
Why choose Inspired Pharma?
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
- For further details click on the tabs below
Delegate feedback on our online courses
We all found this course very accessible and easy to follow. It has been a great help to our Company
The whole course has been extremely well structured and I have enjoyed taking it
Delegate feedback on our Data Integrity courses
Informative on the subject, tutor was able to help with all questions
Very informative, relevant, well presented
A good introduction to the challenges of governance for data integrity
The team who have designed and built this course
David is a Computer Systems Validation and Compliance expert. He has worked in the IT/Computer Systems arena for almost 30 years, the last 16 years he has provided Consultancy, Auditing and Training to the pharmaceutical/biotech and healthcare industry across the UK, Europe, Asia and the U.S.A. He is a Chartered Engineer with both the MIET and the MInstMC and a member of the GAMP MES SIG. He is involved in our data integrity and computers systems auditing courses.
Dominic Parry has worked in the pharmaceutical industry since 1992, and is a leading pharmaceutical quality management specialist. He is generally recognised as one of the leading GMP trainers in the UK and brings an enormous amount of interest, enthusiasm and fun into the training he presents.
Ron has been involved in the learning and development industry for over 20 years. He is a Fellow of the Learning and Performance Institute and in 2004 received the LPI ‘Colin Corder’ award for outstanding services to the training industry. He is the architect behind our website and our learning platform and also develops the web-based learning courses that we now offer to support many of our learning programmes. In addition, he also provides general business support on strategy and sales and marketing.
Find out about our course ranges
QMS News and Articles
Read our articles on QMS regulatory developments as well as news about our QMS training courses.
About Inspired Pharma
We help people in pharma organisations to continually improve their regulatory systems to gain competitive advantage and ensure compliance.
We offer a wide range of highly praised and respected classroom and online training courses and also provide our global pharma clients with consultancy support. Our classroom courses are available on a public schedule and also can be customised for inhouse delivery at a client site.
Find your way quickly to any part of our website by selecting any of the links in this section
Forthcoming Public Courses
All pharma training courses held in Reading UK unless stated otherwise. Click on course name for full details.
Online courses available anytime anywhere
Each course typically consists of 10-20 minute chapters of content followed by a quiz based assessment. The QP courses feature tutor assessment too. The learning is accessed over the internet using desktop computers, laptops, tablets and even smartphones.