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.
Who will the course benefit? This 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.
- 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 add 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
David Thompson is a computer systems validation and compliance expert. He has worked in the IT/Computer Systems arena for almost 30 years, the last 16 years he has provided Consultancy, Auditing and Training to the pharmaceutical/biotech and healthcare industry across the UK, Europe, Asia and the U.S.A. He is a Chartered Engineer with both the MIET and the MInstMC and a member of the GAMP MES SIG. In his current role he is Owner and Principal Consultant of Clarity Compliance Solutions Limited.
Reading, Berkshire, UK
The Holiday Inn – Reading South, 500 Basingstoke Road, Reading, Berkshire, RG2 0SL, UK. The hotel is very close to Junction 11 of the M4 – 25 miles west of London’s Heathrow Airport.
Telephone: + 44 (0)871 942 9067
Payment: Payment can be made by cheque, electronic transfer, credit or debit card. Payment must be made before the course start date. Either payment or a Purchase Order number will be required to secure a place on the course.
VAT will not be charged for courses held outside the UK. VAT will be charged for the courses held in the UK, however delegates from outside the UK but within the European Union (EU) will not be charged VAT if they supply their own company’s national VAT number when booking. VAT will not be charged for any delegates coming from outside the EU.
The cost includes:
- Refreshments and lunch during the course times.
- Course folder containing copies of slides and supplementary notes and handouts.
- Course attendance certificate.
- Full tutor support and access during course times.