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Online Data Integrity course - understand the threats and issues

A short online course, approved by the Royal Society of Chemistry, to help you to ensure your team understand their role in meeting current regulatory expectations regarding Data Integrity

 

Key InformationWhy Inspired?

An online Data Integrity course, approved by the Royal Society of Chemistry, 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.

In December 2021 the RSC re-approved this course for a further 3 years. The RSC Assessor commented:

“This is a short course for Data Integrity and it meets the aim in a very simple and effective way: it delivers the essential information everybody working in pharmaceutical businesses must know.

Use the links below to navigate around this page:

Make a Booking

To make a booking for you and your team use one of the panels below:

For up to 50 learners on our online learning platformn our online platform.

Add each learner as a delegate on the booking form:

1 up to 9 learners for £50 per learner

10 to 24 delegates and the cost per learner reduces to £45

25 to 50 delegatesand the cost per learner reduces to £40

If there are more than 50 learners please contact us for a quote.

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.

PLEASE NOTE: For details of how the online learning works and what will happen once you make a booking read the text below the heading ‘Using our online system’ describing this area in more detail.

Once you have completed the course you will be able to print a Certificate including the RSC ‘Approved Training’ logo.

To try a free taster of these courses to see if they are of interest visit this page.

There is also a one-day public course if you need a full understanding in this area – click here for more details.

Based outside the UK?

If so, be sure to pick the 'Tax Exempt' options in the payment method list when you are  making a booking. If you are based in the EU then you must also enter your VAT number to qualify to be exempt from VAT.

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! Approved by the RSC.

 

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
  • ALCOA+ Update
  • 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 with our logo and the RSC Approved Training logo 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. If they do not complete the course within this time then you will need to pay again to complete the course. A certificate is only issued once the course is completed in full.

Groups up to 50

You can use the button in the panel above to purchase multiple licenses for up to 50 learners.  Once we have received your payment we will set up your team in our system. The team administrator (assumed to be the booker unless you tell us otherwise) 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.

Larger Groups

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.

Versions available:

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 with our logo and the RSC Approved Training logo is available for download by the trainee and/or the team administrators
  • It’s simple, flexible and very cost effective
  • Approved by the RSC

Delegate Feedback

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Our Experts

The team who have designed and built this course

David Thompson

David Thompson

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

Dominic Parry has worked in the pharmaceutical industry since 1992 and is a leading pharmaceutical quality management specialist.  He initially worked for Evans Medical Limited as a Production Development Scientist.  He then moved to Hoechst Marion Roussel where he worked as a Quality Assurance Officer and then Validation Manager for the sterile manufacturing operations.

Over the past 20 years he has worked as a leading pharmaceutical trainer and Quality Management System specialist.  He works closely with pharmaceutical companies and their suppliers on evaluating, developing and continually improving their quality systems so that they add real-value to organisations.  He has a real passion for training in the pharmaceutical industry and has presented GMP and Quality Management related training courses all over the world.  He is an IRCA registered GMP Lead Auditor and regularly performs audits of pharmaceutical companies and their suppliers.

Ron Orme

Ron Orme

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

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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.

Quick Links

Find your way quickly to any part of our website by selecting any of the links in this section:

Our Public Course range

Most of our public courses are currently being delivered using our proven 'live online interactive' courseware enabling you to attend the course from your home or workplace and be heard and seen throughout, just as you would be if we were in a room together. In 2022 we will also begin to offer some traditional classroom courses - see details on each course page.

Click on course name for full course details and dates:

Pharmaceutical GMP Auditor/Lead Auditor

Advanced Good Manufacturing Practice

Data Integrity

Documentation and Records in GMP

Good Distribution Practice

Good Manufacturing Practice

Internal Auditor

GMP Problem Solving

Responsible Person (RP)

Sterile Products

Online courses available anytime anywhere 

Data Integrity

Good Distribution Practice (GDP)

Good Manufacturing Practice (GMP)

Pharma Quality Management Systems module

QP Medicinal Chemistry & Therapeutics module 

QP Quality Management Systems module

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.

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