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Introduction

Who will the course benefit?

This Data Integrity training course is aimed principally at Management and Supervisory roles who need a detailed understanding of the Data Integrity requirements and regulatory expectations. The course will provide the delegates with the understanding required to enable implementation of required Data Integrity governance systems, methodologies and programmes.

Course overview:

Delegates will learn about Data Integrity threats and issues posed within paper and electronic systems and how to comply with regulatory requirements. Delegates will leave the course with a clear understanding of the current expectations of EU Inspectors (such as the UK’s MHRA) and the FDA.

We now have a 20-minute online Data Integrity course designed to bring your team up to speed on this important topic - visit our website for more details

Course contents:

• Background and introduction to Data Integrity
• Industry Regulations and Guidance
• Data integrity applied to paper-based and computer-based systems
• Introduction to the Data Life cycle model:
• Stage 1 – Data Collection
• Stage 2 – Data Processing
• Stage 3 – Data Review
• Stage 4 – Data Reporting
• Stage 5 – Data Archiving
• Data Archiving and ALCOA principles
• Risk identification, audit challenge and threat management
• The Governance System – what do you need?
• Outsourced GMP activities – expectations and implications
• Identification of audit challenges and additional governance
• Implications for new projects
• Review of example warning letters and citations

Useful links

Speakers

• David Thompson United Kingdom

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Venue

Holiday Inn Reading

Holiday Inn Reading, Reading South, 500 Basingstoke Road, Reading , RG2 0SL, United Kingdom

Organised by

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Contact information

Dominic Parry
Inspired Pharma Training
1210 Parkview, Arlington Business Park, Theale, Reading, Berkshire RG7 4TY
+44 1635 866699
Contact us by email

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