- Live online
- In-house
- 6 CPD hours
Data Integrity and Document Management Training Course ★★★★★
Data integrity is a critical issue in document governance and is increasingly becoming a focus for regulatory inspections globally. This course will equip you with the necessary knowledge to identify and avoid potential data integrity issues before auditors do. More details...
Live online
- 09:30 - 17:00 UK (London) (UTC+00)
- 10:30 - 18:00 Paris (UTC+01)
- 04:30 - 12:00 New York (UTC-05)
Course code 16615
£649 / €909 / $1,043
Pricing details: multiple places, early booking discounts
Live online
- 09:30 - 17:00 UK (London) (UTC+01)
- 10:30 - 18:00 Paris (UTC+02)
- 04:30 - 12:00 New York (UTC-04)
Course code 17252
3rd place FREE
£649 / €909 / $1,043
Pricing details: multiple places, early booking discounts
Live online
- 09:30 - 17:00 UK (London) (UTC+00)
- 10:30 - 18:00 Paris (UTC+01)
- 04:30 - 12:00 New York (UTC-05)
Course code 17561
3rd place FREE
£649 / €909 / $1,043
Pricing details: multiple places, early booking discounts
Tailored to your team's requirements, at your choice of location or online.
From
£500
Per delegate, based on 10 delegates and a duration of 1 day
Course overview
Document management and data integrity are a key focus of regulatory inspections, with both EU and FDA inspectors increasingly observing violations during GxP inspections. It has become a critical issue in document governance and regulators expect staff working in GxP roles to have been trained in this important area.
Ensuring data integrity is an important component of the pharma industry’s responsibility to guarantee the safety, efficacy, and quality of drugs. Violations relating to document management and data integrity have led to numerous regulatory actions, in- cluding warning letters and critical inspection findings. To address these concerns, the FDA, EMA, MHRA and the World Health Organization (WHO) have all recently published data integrity guidelines.
This concise course covers the background to data integrity, why it is important and how its requirements affect both paper-based and computer-based systems. The programme will include discussion of the latest MHRA data integrity guide and EMA TMF guideline that should be considered by organisations involved in any aspect of the GxP pharmaceutical lifecycle (GCP, GMP, GLP and GvP). You will gain an understanding of the requirements for ensuring data integrity, review data integrity inspection findings, and get practical advice on defining and implementing an appropriate data governance process for compliance with data integrity requirements.
This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines.
Benefits of attending
- Understand the importance of data integrity and good document practice
- Ensure you are compliant with the new EU trial master file (TMF) guideline
- Be aware of key regulations and guidelines
- Discuss QMS considerations for data integrity and document management
- Review document management and data integrity inspections to facilitate regulatory compliance
- Consider the requirements for document management and data integrity governance to prevent data integrity breaches
Who should attend
This course is designed for managers and staff from all GxP areas in the pharmaceutical and medical device industries who are responsible for the creation, review, approval and/or reporting of data to ensure data integrity, in particular those working in:
- Clinical trials
- Manufacturing
- Quality assurance/quality control
- Compliance
- Pharmacovigilance
QA personnel from CROs/CMOs and GxP auditors responsible for carrying out audits and self-inspections or external audits will also benefit from the programme.
This course will cover:
Principles of data integrity and good documentation practice
- What is data integrity?
- Why is data integrity important?
- ALCOA principles
- Good documentation practice including paper and electronic records
Data integrity regulations and guidelines
- MHRA/WHO/FDA/EMA/PICS/ICH GCP R2 data integrity guidelines
- Group review and discussion of some key regulated documents including the latest MHRA data integrity guide
Document management and data integrity inspection findings
- MHRA, EMA findings, EU non-compliance reports
- FDA findings
- Group discussion on inspection findings
QMS considerations for data integrity and documentation
- What are the elements of QMS for data integrity?
- Risk management considerations
- Data governance
- Discussion of participants experience and best practice for QMS and data governance
Data integrity for computer systems
- Computer system validation considerations
- What is expected for compliance for GxP systems?
Discussion of document and data integrity issues
- Data integrity and digital signatures
- Certified copies/true copies
- Managing and preventing data integrity breaches
8 Dec 2026
Paul Palmer
Paul R Palmer Ltd
Paul R Palmer is a Director / Pharmaceutical Consultant and a practicing EU / UK Qualified Person. He has over 35 years experience in the pharmaceutical industry in the development, manufacture and supply of medicinal products and medical devices.
Throughout his career, Paul has intentionally taken on all opportunities as they arose in order to develop a broad range of knowledge with an in-depth detailed understanding of manufacturing, storage, distribution, research, computerised systems, as well as the facilities and services to support each.
People and systems have always been a core focus, how to ensure best use, optimise and enhance efficiency. He has a level of curiosity rarely displayed in people taking on the qualified person role in pharmaceutical manufacturing. Culture, behaviour and psychology are all significant influences on the systems and processes we implement, but are often ignored.
Paul studied psychology as part of his MSc in 1993 and has always enjoyed observing the world around him with a curiosity that is rarely satisfied.
21 Jun 2027
13 Dec 2027
Laura Brown
Independent Pharmaceutical Consultant
Dr Laura Brown MBA, BSc, PhD, is a pharmaceutical QA and training consultant and Senior Lecturer for the MSc in Clinical Research at the School of Pharmacy, University of Cardiff. She has more than 20 years’ experience of quality assurance in the pharmaceutical industry and has worked for several companies, including GSK, Hoechst Marion Roussel, Farmitalia and Phoenix International. Laura has a particular expertise in quality assurance including risk-based approaches to quality systems, data integrity and quality project management implementation in the pharmaceutical industry. She was Chair of the ACRPI GCP Forum for six years and regularly writes on pharmaceutical regulatory and quality issues including for the Research Quality Assurance Association’s journal.
8 Dec 2026
Aneta Jell
Paul R Palmer
Aneta Jell is a seasoned Quality Assurance professional with over 20 years of experience
across manufacturing, contract operations, and quality leadership in the pharmaceutical
industry. Currently serving as Quality and training manager at PaulPalmer limited she
oversees global contract manufacturing quality, ensuring GxP compliance, regulatory
alignment, and supply chain integrity. Her expertise spans GMP, ISO 9001, ISO 17025, and
QMS administration, with proven strength in audits, CAPA, deviations, and technical
agreements. A qualified QMS lead auditor with bilingual proficiency in English and Slovak,
Aneta is recognised for driving continuous improvement, fostering compliance culture, and
leading high-performing quality and HSE teams.
Discounts for multiple bookings - bring your colleagues to make your training budget go further:
- 2nd delegate: 30% off
- 3rd delegate: 40% off - or FREE for advance bookings (12 weeks or more)
- 4th delegate: 50% off
- 5+ delegates: contact us for group or bespoke bookings
8 December
Live online
09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 16615
- GBP 649 749
- EUR 909 1,049
- USD 1,043 1,199
Until 03 Nov
- 1 day live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
21 June 27
Live online
09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 17252
- GBP 649 749
- EUR 909 1,049
- USD 1,043 1,199
3rd place FREE until 29 Mar
- 1 day live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
13 December 27
Live online
09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 17561
- GBP 649 749
- EUR 909 1,049
- USD 1,043 1,199
3rd place FREE until 20 Sep
- 1 day live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.
Reviews of IPI's Data Integrity and Document Management training course
Laura was very good, easy to understand and answered any questions
Dec 18 2025
Derek Farrell 
Quality Technician, Fire1 Foundry
Jul 14 2025
It was a very very informative webinar which I certainly will recommend to others
Nanna Sommer 
Clinical Trial Assistant, Minervax ApS
Jul 24 2023
Laura Brown's webinar gave me more confident in data integrity she presented all the necessary information to gain my confident. I really appreciate it.
Kheira Heddi 
Quality Assurance Officer, SGSUK
Jul 24 2023
The content was very useful for my daily work. The presentation was well prepared and the speaker made it easy to listen online.
Christiane Rederath 
Clinical Research Associate, MSD Animal Health Innovation GmbH
Apr 5 2022
Great mix of content, from questions, group tasks, video etc. make it interactive. Great [speaker] allowed time for some discussions and questions, highly appreciated.
Bjarne Hansen
IT QA Specialist, Novo Nordisk A/S. Company Member no. 3431
Oct 4 2021
Personally I found the training very helpful as I realised how the concept of Data Integrity reflects in my daily work. I understood the big impact of Data Integrity in the Clinical Research which is becoming more and more digital.
Chiara Delmaestro 
Chiesi Farmaceutici S.p.A.
Mar 5 2021
This webinar explained very well the complex matter of DI. Very engaging.
Serena Di Molfetta
Study Manager, Menarini Ricerche S.p.A.
Mar 11 2019
Really good speaker, lots of content to read through, covered just about all subject matter we required, presentation slides were good although quite a lot of slides to get through but this is understandable.
Nathan Entwistle
Senior Electronics Technician, Team Consulting
Mar 11 2019
The course is a basic guide to know about DI, to implement it is really a challenge. Overall the course was very useful. Friendliness of the Speaker made the entire session enjoyable.
Firoz Kabir
Senior Quality Assurance Specialist, Sunovion Pharmaceuticals Europe Ltd
Mar 23 2018
Very good, really enjoyed it
Carmel Tynan
QP, Rtex Safety Ltd
United Kingdom
- Advent Bioservices
- Beckley Psytech Ltd
- Colorcon Ltd
- Mexichem UK Ltd
- Mundipharma Reseach Ltd
- Mundipharma Research Ltd
- Oxford Lasers
- Psychosis Research Unit
- Sekisui Diagnostics
- Sekisui Diagnostics (UK) Ltd
- Seqirus
- SGS
- SGSUK
- Sunovion Pharmaceuticals Europe Ltd
- Team Consulting
- Thermo Fisher Scientific
Ireland
- Carroll Compliance Ltd
- Fire1 Foundry
- LEO PHARMA
- Rtex Safety Ltd
Austria
- Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- MED-EL Medical Electronics
- Octapharma ProduktionsgesmbH
Denmark
- LEO Pharma A/S
- Minervax ApS
- Novo Nordisk A/S. Company Member no. 3431
Italy
- Chiesi Farmaceutici S.p.A.
- Menarini Ricerche S.p.A.
- SENTINEL CH. SpA
Spain
- FAES FARMA SA
- FAES FARMA, S.A.
- HIPRA
Belgium
- CIRLAM
- Oystershell
Germany
- Bionorica SE
- MSD Animal Health Innovation GmbH
France
- Boehringer Ingelheim
Greece
- Rontis Hellas S.A.
Hungary
- Richter Gedeon Plc.
Israel
- Gsap Biomed
Latvia
- AS Kalceks
Netherlands
- ProQR Therapeutics N.V.
Portugal
- Bial - Portela & Ca, SA
Sweden
- HemoCue AB
Turkey
- Dollvet
United States of America
- Kalvista Pharmaceuticals
Run Data Integrity and Document Management Live online for your team
1 day
Typical duration
Pricing from:
- GBP 500
- Per attendee, based on 10 attendees
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our team to discuss your requirements:
