Short Course Listings
Short Course

Course Information
Course Title: Meeting FDA and EU Requirements for Data Integrity in GXP Laboratories
Categories: 1 - Pharmaceutical Sciences
2 - Data Analysis
3 - Data Management
4 - Quality/Regulatory/Compliance
5 - Electronic Laboratory
Instructor(s): Bob McDowall Course Number: 81
Affiliation: R D McDowall Ltd
Course Date: 03/07/2016 - Monday Course Length: 1 Day Course
Start Time: 08:30 AM End Time: 05:00 PM
Fee: $550 ($750 after 2/12/16) 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. The UK regulator, MHRA, have issued a guidance for industry on the topic to help interpret regulatory requirements. This short course through a mixture of presentations, facilitated discussions and workshops is designed to help attendees understand the requirements of the GMP regulations and 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 GX laboratories GXP Laboratory managers responsible for computerised systems QA personnel responsible for computerised systems IT managers supporting GXP informatics systems CRO or CMO laboratory staff responsible for computerised systems

Course Outline
Introduction to Course and the Instructor
Why is Data Integrity Important? Understanding FDA and MHRA guidance for data integrity
Role of Management in Data Integrity
Principles of Data Integrity
US 21 CFR 211 and EU GMP Chapter 4: Complete data v raw data
Ten Compliance Commandments for Laboratory Systems
Facilitated Discussion / Workshop on Key Data Integrity Topics
Workshop: Developing a Data Integrity Plan
Key Learning Points and Final Discussion

Course Instructor's Biography
Dr Bob McDowall is an analytical chemist with over 40 years experience including 35 years experience of LIMS and other laboratory informatics systems. Bob edited the first book on LIMS and has published extensively on the subject with over 60 published papers and more than 50 workshops on the subject run at international symposia and meetings. The LIMS Institute in recognition of his input to the subject and teaching presented him the 1997 LIMS Award. He has written widely on the subject of electronic working and the use of electronic signatures in the laboratory and is also the author of the book on Validation of Chromatography Data Systems. Bob is the writer of the Focus on Quality column in Spectroscopy magazine and the Questions of Quality column in LC-GC Europe. He is Director of R D McDowall Limited and was Visiting Research Fellow at the University of Surrey, UK from 1991 to 2001. Bob is also an industry expert of the GAMP Data Integrity Special Interest Group core group and has written many papers on the subject.