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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.

5 Apr 2022

& 7 Jul 2022 , 10 Oct 2022

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Details

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.

Programme

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

Presenter

Laura Brown (More...)

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.

Book now

Book now

5 Apr 2022
Live webinar
5 Apr 2022
Live webinar
GBP 599 499
EUR 859 719
USD 970 814
Until 1 Mar 22*
Enrol now
to attend
Live webinar
7 Jul 2022
Face-to-face, (venue not yet confirmed)
7 Jul 2022
Face-to-face
(venue not yet confirmed)
GBP 699 599
EUR 979 839
USD 1,090 934
Until 2 Jun 22*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 1 day classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy
10 Oct 2022
Live webinar
10 Oct 2022
Live webinar
GBP 599 499
EUR 859 719
USD 970 814
Until 5 Sep 22*
Enrol now
to attend
Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code

Continuing professional development

This course qualifies for 6 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

Previous customers include...

  • Carroll Compliance Ltd
  • Chiesi Farmaceutici S.p.A.
  • CIRLAM
  • Dermal Laboratories Ltd
  • FAES FARMA SA
  • FAES FARMA, S.A.
  • HemoCue AB
  • Kalvista Pharmaceuticals
  • LEO Pharma A/S
  • Med-El Elektromedizinische Geraete Gesellschaft m.b.H.
  • Menarini Ricerche S.p.A.
  • Mexichem UK Ltd
  • Mundipharma Reseach Ltd
  • Mundipharma Research Ltd
  • Oystershell
  • ProQR Therapeutics N.V.
  • Rtex Safety Ltd
  • Sekisui Diagnostics
  • Sekisui Diagnostics (UK) Ltd
  • Seqirus
  • Sunovion Pharmaceuticals Europe Ltd
  • Team Consulting

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., Oct 21

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

Serena Di Molfetta, Study Manager, Menarini Ricerche S.p.A., Mar 21

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 19

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 19

Very good, really enjoyed it

Carmel Tynan, QP, Rtex Safety Ltd, Mar 18