Data Integrity for Manufacturing Records

This webinar will provide an insight into the thinking behind the ISPE GAMP Good Practice Guide ‘Data Integrity – Manufacturing Records’.
Presented by Karen Ashworth, who led the team that developed the process control systems input to the guide, the presentation will explain:
What types of data are typically collected by manufacturing systems
How to decide which of these are GxP critical
How do the data integrity risks vary for different types of record
The importance of understanding data flows
Using our knowledge of data flows to identify and mitigate risks

Karen Ashworth
Karen is a validation consultant specialising in the validation of process control systems, working mostly with suppliers to the life sciences industry.
Karen has over thirty years of experience in process automation including roles as system owner, production manager, control system supplier, quality systems internal auditor and consultant. During this time, she has worked in a wide range of industries including nuclear, metal heat treatment and fine chemicals as well as life sciences and has managed projects from small environmental monitoring systems up to multi-million pound control systems.
Karen is a member of the UK GAMP COP Steering Committee. She was part of the editorial team for the GAMP Good Practice Guides ‘Testing of GxP Critical Systems’ and ‘A Risk Based Approach to Process Control Systems’ and she co-led the international team who updated the testing good practice guide. Karen was lead author on the ISPE Practical Approaches to Data Integrity for Manufacturing Systems and she delivers the ISPE risk based validation of process control systems training course.