This seminar is aimed at an Intermediate level, and will be an Interactive day of Presentations, Workshops and discussions on key Data Integrity topics including:
• ALCOA+ Principles
• The Data Lifecycle
• Regulatory Expectations (Update on any recent publications of relevance)
• The Principles of Computerised System Validation
• Introduction to Audit Trails in the GXP Setting
• Audit Trail Workshop
• Expert Panel - Question & Answer Session
Following requests from attendees of previous RQA events we are pleased to offer seminar material in PDF format for delegates attending this seminar.
The material will be emailed in advance of the seminar and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions.
Accommodation is available at Novotel Heathrow by booking directly with the hotel.
09:45 The Principles of Computerised System Validation
11:00 Introduction to Audit Trails in the GXP Setting
Introduction & Overview with Workshop
12:45 Audit Trail Workshop
Considering a variety of systems – actual systems will depend on availability of example outputs
Task to review audit trails from different critical GXP systems
13:30 Task Feedback
15:30 Knowledge Check /Quiz
16:00 Course Feedback and Close