Online Data Integrity course - understand the threats and issuesA short online course to ensure your team understand their role in meeting current regulatory expectations regarding Data Integrity
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 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.
For further details click on the tabs below or to try a free Taster course subscribe using the panel near the bottom of the page. To make a booking for you and your team use the panel below
|Course options||Cost||Click below to book|
|Up to 10 learners on our online platform||£450 for 2 months access|
|Up to 25 learners on our online platform||£999 for 2 months access|
|Over 50 learners and/or courseware purchase||Please contact us||Send us an email|
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.
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 using the panel near the bottom of the page. There is also a one-day public course if you need a full understanding in this area – click here for more details.
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.
What our clients say about our online learning courses:
“We all found this course very accessible and easy to follow. It has been a great help to our Company” Tim Webb, Business Development Manager, Cougar Couriers
“This course is inspiring” Pharmaceutical Consultant
“I liked the course very much and wish to do other modules” QA Manager, Astellas
“Well structured and informative” Qualified Person, Monrol
“The course is informative, well-structured and easily digested” Pharmaceutical Consultant
“I will definitely recommend it for other colleagues” QA Manager, GlaxoSmithKline
What our clients say about our Data Integrity Training:
“Good, provided useful information” QA Manager,Waymade
“Very informative. Good interaction” QA Systems Specialist,MedImmune
“Very useful, would recommend to others for a good grounding” Validation Manager,Oxford BioMedica
“Very informative, relevant, well presented” Head of Analytical Services, Oxford BioMedica
“Informative on the subject, tutor was able to help with all questions” Quality Executive, GSK
“A good introduction to the challenges of governance for data integrity” Director, EU GMP Compliance, Eisai
“Great” Validation Analyst,Bruhealth
“David worked with senior management and key operational staff bringing a focus to the increased requirements with regard to data integrity. He presented a series of interactive training modules which were very well received and enabled staff to fully understand how we as a business need to further develop our systems. All feedback from the training was very positive. Ultimately our processes and procedures satisfactorily met the MHRA expectations during our recent audit. Personally I found David easy to work with and I would highly recommend him as somebody who could bring knowledge and clarity to the area of data integrity”. Ashley Brierley, Quality and Regulatory Director, Thornton Ross about an in-company programme
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
Experts behind this programme
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. In his current role he is Owner and Principal Consultant of Clarity Compliance Solutions Ltd.
Dominic Parry has worked in the pharmaceutical industry since 1992, and is a leading pharmaceutical quality management specialist. He worked for 4 years at Evans Medical Limited (now Novartis Vaccines) as a Production Development Scientist. He then moved to Hoechst Marion Roussel (now Patheon, UK), where he worked for 4 years as a Quality Assurance Officer and then Validation Manager for the sterile manufacturing operations.Over the past 15 years he has worked as a leading pharmaceutical GMP trainer and Quality Management System specialist. He works closely with pharmaceutical companies and their suppliers on evaluating, developing and continually improving their quality systems.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. He is Managing Director of Inspired Pharma Training Ltd.
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 of 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.
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 enrolled in some short video based courses taking no more than 10 minutes to complete. 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.
Prices shown in the panel above excludes UK Value Added Tax (VAT) at 20% which will also be charged for UK based organisations. VAT will not be charged for organisations from outside of the European Union (EU) or for organisations from within the EU if they supply their company’s VAT number when booking.
Access anywhere and anytime:
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.
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.No certificate is issued if the course is not completed in full.
Purchase of materials:
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.