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Data Integrity course - understand the threats and issues

Understand the current expectations of EU Inspectors and the FDA regarding Data Integrity threats and issues 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.
Key Course infoWhy Inspired Pharma

Understand the current expectations of EU Inspectors and the FDA regarding Data Integrity threats and issues

Data Integrity is currently a MAJOR focus area during regulatory inspections, with a number of recent regulatory guidance documents published on the subject.  It is therefore essential that you have the correct understanding of what is required.  This course covers the background to Data Integrity, why it is important and how its requirements affect both paper-based and computer-based systems.

Attend this one-day course and you will leave with a clear understanding of the expectations of EU Inspectors (such as the UK’s MHRA) and the FDA.  Moreover,  you will possess the understanding required to enable implementation of the required Data Integrity governance systems, methodologies and programmes within your organisation.

Use these links to navigate around this page: 

Make a Booking

Our one-day Data Integrity training course is available on the following dates:

Tuesday 6th October 2020

Venue: Your home or workplace using our proven ‘live online interactive’ courseware

Wednesday 3rd February 2021

Venue: Your home or workplace using our proven ‘live online interactive’ courseware

Wednesday 9th June 2021

Venue: Your home or workplace using our proven ‘live online interactive’ courseware

Thursday 28th October 2021

Venue: Your home or workplace using our proven ‘live online interactive’ courseware

Coronavirus Update

Due to the uncertainties involved in travel at the moment we will be delivering all of our public courses using our proven 'live online interactive' technology. Delegate feedback from the courses we delivered in June and July has been just as positive as our classroom courses and in addition, many people have enjoyed not having to travel in these difficult times.

All Dates:

The cost is £695 plus VAT. Course will be charged in GB pounds. For full details of what is included in the cost see below.

Payment can be made by cheque, electronic transfer, credit or debit card. Payment must be made before the course start date. Either payment or a Purchase Order number will be required to secure a place on the course.

If you plan to pay by credit card then you should first look at this helpful information.

Alternatively, if you want to discuss any aspect of this course or want to reserve a place, please send an email with your enquiry or call +44 1635 866699.

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.

Group Bookings - discounts of up to 50% 

Book 2 or more individuals from the same company for the same course date to enjoy substantial discounts. The first booking is charged at the full published rate with the second booking charged at full published rate minus 20%. A third or fourth booking is charged at full published rate minus 50%. These discounts are applied automatically when you make a booking.

Key Course Information

Who will the course benefit?

This Data Integrity training course is aimed principally at Management and Supervisory roles who need a detailed understanding of the Data Integrity requirements and regulatory expectations. The course will provide the delegates with the understanding required to enable implementation of required Data Integrity governance systems, methodologies and programmes.

TAKE NOTE! We now have a 20-minute online Data Integrity course designed to bring your team up to speed on this important topic – click here for more details.

Course overview

Delegates will learn about Data Integrity threats and issues posed within paper and electronic 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.

Course content

  • Background and introduction to Data Integrity
  • Industry Regulations and Guidance
  • Data integrity applied to paper-based and computer-based systems
  • Introduction to the Data Life cycle model
    • Stage 1 – Data Collection
    • Stage 2 – Data Processing
    • Stage 3 – Data Review
    • Stage 4 – Data Reporting
    • Stage 5 – Data Archiving
  • Data Archiving and ALCOA principles
  • Risk identification, audit challenge and threat management
  • The Governance System – what do you need?
  • Outsourced GMP activities – expectations and implications
  • Identification of audit challenges and additional governance
  • Implications for new projects
  • Review of example warning letters and citations

 Course cost:

£695  per delegate plus VAT. Course will be charged in GB pounds.

However delegates from outside the UK but within the European Union (EU) will not be charged VAT if they supply their own company’s national VAT number when booking. VAT will not be charged for any delegates coming from outside the EU.

The cost includes:.

  • Course folder containing copies of slides and supplementary notes and handouts.
  • Course attendance certificate.
  • Full tutor support and access during course times.

    Times: 

    09.00 – 17.00 consisting of four 90 minute live interactive online and 3 breaks of at least 30 minutes

Live Online Interactive Training

Stay Safe - Attend from home or whilst at work

With 2 expert facilitators and a maximum of 10 delegates our course will utilise state-of-the art interactive online classroom software that will enable you to:

  • chat online with the facilitators and other delegates
  • raise your 'virtual' hand to ask a question
  • participate anonymously in a poll or survey and see an instant display of the class results
  • undertake exercises on your own or in a group

And best of all, no travel is needed nor a stay in a hotel reducing any risks of COVID-19 and saving you a lot of time, hassle and money. 

As always we will ensure this event is inspirational, enjoyable and educational. See the feedback below:

What is involved?

We will send you a link to the live online interactive course with your joining instructions once you have booked your place. 

You should log into the training session 10-15 minutes before the start time, to ensure that you have set up the courseware  correctly. The course will start precisely on time and it may not be possible to go back over material missed by late arrivals.

Your active participation is expected: everyone will be heard and seen throughout, just as they would be if we were in a room together. To be heard, hear and be seen you will need a microphone, speakers and camera — if you have a modern laptop that’s all you will need. Remember, you’ll need a quiet place to call from and a decent internet connection is a must.

I found the interaction very good by using the chat option as it keeps everyone interested and there was a variety of questions and answers.

Quality / EHS Specialist, DCC VITAL

Great course, although it was virtual I felt we got the same value for money as if it was F2F, a 10 out of 10!!! I will recommend to colleagues

Quality Executive, ABPI

The GMP course was ran very well. Both presenters were very knowledgeable in the area, both for the EU and other countries. I would highly recommend this course to those who are new to the area of GMP, as well as those who just need a bit of a refresher.

 

Training Officer, THORNTON & ROSS

Why choose Inspired Pharma?

Expert Tutor

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. In his current role he is Owner and Principal Consultant of Clarity Compliance Solutions Ltd.

The tesimonial below relates to an in-house programme delivered by David:

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

Delegate Feedback

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

Informative on the subject, tutor was able to help with all questions

Quality Executive, GSK

Very informative, relevant, well presented

Head of Analytical Services, OXFORD BIOMEDICA

A good introduction to the challenges of governance for data integrity

Director, EU GMP Compliance, EISAI

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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.

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Forthcoming Public Courses

All of our public courses are 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.

Click on course name for full details:

2020

September 

29 Advanced GMP

October

06 Responsible Person

06 Data Integrity 

09 Good Distribution Practice

12 Pharma GMP Lead Auditor

20 Good Manufacturing Practice

21 Sterile Products

November

10 Internal Auditor

16 Pharma GMP Lead Auditor

24 Problem Solving

30 Pharma GMP Lead Auditor

December

08 Responsible Person

15-17 Multi-day GMP

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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