Data Integrity and Document Management

Data Integrity is a critical issue in document governance. It increasingly becoming a focus for regulatory inspections globally. This course will equip you with knowledge necessary to identify and avoid potential Data Integrity issues before auditors do.

5 Mar 2020

& 5 Oct 2020

GBP 699 599 *
EUR 979 839 *
USD 1,090 934 *
* When you book before 17 Jan

Book now

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

Final questions and summary discussion

Presenter

Laura Brown

Dr Laura Brown MBA, BSc (Biochemistry), BSc (Psychology), PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years’experience of quality assurance in the pharmaceutical industry and has worked for several companies, including GlaxoWellcome, Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality systems including document management and Data Integrity. She was Chairman of the ACRPI GCP Forum for six years. She regularly writes on pharmaceutical regulatory issues.

Book now

5 Mar 2020
5 Mar 2020 Rembrandt Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
GBP 599.00
EUR 839.00
USD 934.00
Until 17 Jan*
Enrol now
5 Oct 2020
5 Oct 2020 Rembrandt Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
Enrol now

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

Previous customers include...

  • Carroll Compliance Ltd
  • CIRLAM
  • HemoCue AB
  • Mexichem UK Ltd
  • Mundipharma Reseach Ltd
  • Mundipharma Research Ltd
  • Oystershell
  • Rtex Safety Ltd
  • Sekisui Diagnostics (UK) Ltd
  • Seqirus
  • Sunovion Pharmaceuticals Europe Ltd
  • Team Consulting

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

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

Very good, really enjoyed it

Carmel Tynan, QP, Rtex Safety Ltd