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D0 or Dl? Building Data Integrity into your Daily Operations

Seminar Information

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

Seminar Material

Following requests from attendees of previous RQA events we are pleased to offer seminar material in PDF format for delegates attending this seminar. 

The advantages of this include

  • Ability for delegates to keep material on a mobile device
  • Ability to review material at any time pre and post seminar
  • Environmental benefits – less paper being used per 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.

Additional Requirements 
(not included in seminar fees)

Accommodation is available at Novotel Heathrow by booking directly with the hotel.

Seminar Programme

Introduction 

08:30  Registration

08:45  Start

  • Objectives of the Day
  • ALCOA+ Principles
  • Data Life-cycle
  • Regulatory Expectations

09:45 The Principles of Computerised System Validation 

  • High level introduction linking to data integrity concepts
  • Common validation methodologies, errors and issues 

 10:45 Break

 11:00 Introduction to Audit Trails in the GXP Setting 

           Introduction & Overview with Workshop 

  • Points to Consider when reviewing audit trails
  • Paper Trails
  • Guided Example & Task Set-up

12:00 Lunch  

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

  • GCP/GLP – (e.g. eCRF/eDC System)
  • GMP/GLP – (e.g. HPLC/LCMS Analysis of large molecules/gene therapy products)
  • GVP – (e.g.Safety Database)

13:30 Task Feedback 

14:15 Break 

14:30 Questions/Answers/Discussion 

  • Recent Inspection Findings
  • Common audit issues

15:30 Knowledge Check /Quiz 

  • Quiz

16:00 Course Feedback and Close

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