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 Pharma1Understand 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.
Some unique features of our one-day Data Integrity course:
Lively and highly interactive course
Our course is designed to ensure that this is a lively and highly interactive course with practical workshops and exercises throughout the programme. See the incredible feedback from delegates about our ‘live online interactive ‘ courses in this article.
Maximum class sizes
For maximum interactivity and effectiveness, our class size is limited to either 10 delegates (live online interactive) or 12 delegates (classroom) with at least two tutors. The quality and effectiveness of our courses is unrivalled in the industry.
Make a Booking
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IN HOUSE COURSES - this course can also be delivered on your site or using our 'live online interactive' courseware on a date to suit you. If you are interested please contact us at info@inspiredpharma.com . To see our full range of in-house courses and customisation and delivery method options please visit this page.
Academy Skills Library
When a delegate completes their Course Feedback form they will be offered free unlimited access to nearly 400 self-paced online courses for 3 months. For more details select the icon.
Booking details
Select the tabs below to find out all the details you need to know to make a booking:
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.
What's included in cost
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.
Payment
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 RP training 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.
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
Key Course Information
Is this course right for you?
Click on the tabs below to find out if you will benefit from attending this course:
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 Times:
09.00 – 17.00 consisting of four 90 minute live interactive online and 3 breaks of at least 30 minutes
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
Live Online Interactive Training
This course is currently only available using our proven ‘live online interactive’ format. Select the tabs below to find out more:
Stay Safe - Attend from home or whilst at work
With 2 and sometimes 3 expert facilitators and a maximum of 8 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?
For this certified course IRCA lay down strict requirements in terms of the hours of learning (40+), continuous assessment and the supervision of the exam. This means that you will need to undertake just over 3 hours of online learning prior to the 5 day event and that the event itself will be very intensive and includes evening work – see Timetable details above. It is very important that during the 5-day event you focus totally on the course and that distractions are minimal.
We will send you detailed joining instructions once you have booked your place and in sufficient time for you to undertake the pre-course work..
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.
Why choose Inspired Pharma?
Expert Tutors
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 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.
Matt is a dynamic, energetic and authentic trainer who demonstrates his passion and communicates this to all who encounter him. He began his Pharma career at Napp Laboratories before having short spells in related industries. He then spent 15 years with GlaxoSmithKline gaining extensive knowledge of GMP from roles in Packaging, Logistics and QC.
More recently, Matt worked as GMP Learning and Development Manager for Lonza Biologics and draws on all his varied experience to create a lively, relevant training environment.
Delegate Feedback
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
Good, provided useful information
Very informative. Good interaction
Very useful, would recommend to others for a good grounding.
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
Recent independently verified reviews about this course from Review.io
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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.
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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.
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Pharmaceutical GMP Auditor/Lead Auditor
Advanced Good Manufacturing Practice
Online courses available anytime anywhere
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.