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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.

★★★★★ "Personally I found the training very helpful as I realised how the concept of Data Integrity reflect... more"

7 Jul 2022 + 1 more date

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Format: Live online
CPD: 6 hours for your records
Certificate of completion

Data Integrity and Document Management

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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.

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.

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The Data Integrity and Document Management 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

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Laura Brown

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.

More details

Book Data Integrity and Document Management Live online training

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

7 Jul 2022

Live online

Course code 11391

GBP 499 599
EUR 719 859
USD 814 970

Until 02 Jun

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

View basket

10 Oct 2022

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 11718

GBP 499 599
EUR 719 859
USD 814 970

Until 05 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

View basket

* 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.

Reviews of IPI's Data Integrity and Document Management training course

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.

Oct 4 2021

Chiara Delmaestro Italy
Chiesi Farmaceutici S.p.A.

Mar 5 2021

This webinar explained very well the complex matter of DI. Very engaging.

Serena Di Molfetta Italy
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 United Kingdom
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 United Kingdom
Senior Quality Assurance Specialist, Sunovion Pharmaceuticals Europe Ltd

Mar 23 2018

Very good, really enjoyed it

Carmel Tynan Ireland
QP, Rtex Safety Ltd