Presented by
Management Forum
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 + 2 more dates
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:
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:
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.
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.
5 Apr 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 11564
Until 01 Mar
7 Jul 2022
Classroom
London venue TBC
00:00-00:00 UK (London)
Course code 11391
Until 02 Jun
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
Until 05 Sep
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 
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
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