Data Integrity course - understand the threats and issuesUnderstand the current expectations of EU Inspectors and the FDA regarding Data Integrity threats and issues
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 required the Data Integrity governance systems, methodologies and programmes within your organisation. Our one-day Data Integrity training course is available on the following dates:
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.
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.
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.
UK courses (Reading, Berkshire)
The Holiday Inn – Reading South, 500 Basingstoke Road, Reading, Berkshire, RG2 0SL, UK. The hotel is very close to Junction 11 of the M4 – 25 miles west of London’s Heathrow Airport.
Telephone: + 44 (0)871 942 9067
e-mail: [email protected]
A special rate of £121 (including VAT) has been agreed with the hotel (subject to availability). This is for Bed and Breakfast and includes internet access. Quote “Inspired Pharma” when making your booking.
Data Integrity Course cost:
£595 per delegate plus VAT. Course will be charged in GB pounds.
VAT will not be charged for courses held outside the UK. VAT will be charged for the courses held in the UK, 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 of accommodation is not included in the course cost. If required you should book accommodation yourself directly with the hotel.
The cost includes:
- Refreshments and lunch during the course times.
- Course folder containing copies of slides and supplementary notes and handouts.
- Course attendance certificate.
- Full tutor support and access during course times.
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.
To book a place on the Data Integrity course please use the online booking system by selecting the ‘Book Now’ button on the event of your choice (at the top of the screen/page)
Feedback from previous delegates:
“Good, provided useful information”
QA Manager, Waymade
“Very informative. Good interaction”
QA Systems Specialist, MedImmune
Validation Analyst, Bruhealth
“Informative on the subject, tutor was able to help with all questions”
Quality Executive, GSK
“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
“A good introduction to the challenges of governance for data integrity”
Director, EU GMP Compliance, Eisai
“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
See top of this page for current public dates. Also available for in-house delivery, and may be customised if required.
09.00 – 16.30.
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.
- 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 add 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