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Data Integrity and Document Management

Management Forum
Course summary
1 day
English
London
Next available date: 05/10/2020 - London
Professional Training

Data Integrity and Document Management

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.

Provider: Management Forum

Management Forum

Management Forum - Professional training courses for the Life Sciences and Intellectual Property Sectors

Management Forum is an internationally renowned training provider organising professional conferences, seminars and in-house courses for professionals and companies in the Life Sciences and Intellectual Property sectors. With their growing programme portfolio, training specialists at Management Forum aim to provide...


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Contact information for Management Forum

Management Forum

98-100 Maybury Road
GU21 5JL Woking

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www.management-forum.co.uk


Reviews by course attendees

Average rating 4

Based on 2 reviews

Nathan
(4)
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.
Firoz
(4)
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.
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