Audience

Suitable for people with the responsibility of ensuring or assessing the GMP compliance to requirements and expectations relating to the control and management of data within the pharmaceutical industry.

Duration

1 day

Objectives

By the end of this course you will:
• Understand the importance of data integrity
• Appreciate how data integrity could impact your facility
• Know how to integrate data governance into your quality systems
• Recognise the challenges and therefore be able to identify areas where falsification could occur
• Understand the difference between mistakes and falsification or fraud
• Be able to identify the data lifecycle elements for both manual (paper) and electronic data
• Understand the potential risks and weaknesses associated with the lack of control of data
• Know how to incorporate the aspects of data integrity into the design and qualification of new equipment
• Be able to check for compliance against data integrity expectations

Content

This course is designed to provide guidance on how data should be controlled and managed from initial generation and recording, through processing, use, retention, archiving and retrieval. Data Integrity is assuming greater importance in cGMP, with both the FDA and European Regulatory Agencies placing a high degree of focus on the subject.

• Introduction and Basics of Data Integrity
• Exercise ‘defining your awareness’
• Understanding Data
• Defining Data Integrity
• The Data Lifecycle
• DI Infringements &Trends
• Data Governance and Basic Principles
• Application of Controls

Cost

Non-Member - £695 + VAT
One Nucleus Member* – £556 + VAT

*Please email training@onenucleus.com for the ON member discount code.

Training provided by

Tel: 0118 918 4076
Email: bookings@rssl.com