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Short Course

Course Information
Course Title: Data Integrity: Understanding GXP Regulatory Requirements for Laboratories
Categories: 1 - Pharmaceutical Sciences
2 - Data Analysis
3 - Data Management
4 - Quality/Regulatory/Compliance
5 - Electronic Laboratory
Instructor(s): Bob McDowall Course Number: 145
Affiliation: R D McDowall Ltd
Course Date: 03/06/2017 - Monday Course Length: 1 Day Course
Start Time: 08:30 AM End Time: 05:00 PM
Fee: $575 ($775 after 2/18/17) Textbook Fee:

Course Description
Data integrity in regulated laboratories is the hot topic with regulatory agencies either due to falsification of data or bad data management practices. FDA inspectors in particular have discovered an increasing number of cases of data falsification in recent years involving both paper and laboratory computerised systems. This can vary from the retrospective generation of sample weights, copying of an IR spectrum from a passing batch of material to another batch to the industrial scale falsification at Able Laboratories. The Able Laboratories case was particularly worrying for the FDA as the company had undergone several inspections that focussed on paper records which did not detect any falsification. In response, the FDA issued in 2010 an updated Compliance Program Guide (CPG) 7346.832 for pre-approval inspections which became effective in 2012. This has three objectives for inspectors conducting PAIs, of which objective 3 is a laboratory data integrity audit. In Europe the UK regulatory authority has published an expectation that internal audits need to focus on data integrity both in the company but also its suppliers. In addition, FDA, WHO and MHRA have issued guidance for data integrity with further guidance issued by the EMA and PIC/S. These show that data integrity is more than just numbers. This short course through a mixture of presentations and facilitated discussions is designed to help attendees understand the requirements of the GMP regulations and regulatory guidance as well as the CPG for laboratory records to ensure the integrity of data. This is designed to help laboratories reinforce existing controls and where necessary implement new ones to ensure that inspections of laboratory data can be handled with confidence.

Target Audience
• Owners of computerised systems in regulated GMP laboratories • GMP Laboratory managers responsible for computerised systems • QA personnel responsible for computerised systems • IT managers supporting GMP informatics systems • CRO or CMO laboratory staff responsible for computerised systems

Course Outline
Introduction to the course
Why is Data Integrity Important?
Understanding FDA, WHO, EMA, PIC/S and MHRA guidance documents for data integrity
Data Integrity is more than numbers: a data integrity model
Management Leadership and Data Governance
Principles of data integrity applied to paper, hybrid and electronic systems
Training for data integrity
Complete data v raw data
Handling blank or template forms

Course Instructor's Biography
Dr Bob McDowall is an analytical chemist with over 40 years experience including 35 years experience of laboratory informatics, computer validation and data integrity. Bob has written widely on data integrity over the past 10 years and has trained analytical chemists on the subject and has been involved in remediation work following regulatory inspections. The second edition of Validation of Chromatography Data Systems has recently been published which focuses on data integrity and ensuring that the systems comply with the definition of intended use