Course Information
Course Title: Designing and Implementing the Electronic Laboratory
Categories: 1 - Life Sciences
2 - Pharmaceutical Sciences
3 - Data Analysis
4 - Quality/Regulatory/Compliance
5 - Validation
6 - Laboratory Information and Management
Instructor(s): Robert McDowall Course Number: 126
Affiliation: McDowall Consulting
Course Date: 03/12/2012 - Monday Course Length: 1 Day Course
Start Time: 08:30 AM End Time: 05:00 PM
Fee: $455 ($655 after 2/13/12) Textbook Fee:

Course Description
Business pressures are forcing the pharmaceutical industry to reduce costs and improve efficiency. Analytical laboratories both in R&D and manufacturing are one of the rate limiting areas where often the business is waiting on the analytical results before making a decision on what to do next or release a product. Efficiency improvements are clearly and urgently required but how should a laboratory plan to achieve them? The electronic laboratory has been a dream for a number of years. Now we have the regulations in 21 CFR 11 in the US and the 2011 version of GMP Annex 11 in Europe that allow us to work electronically and sign records with electronic signatures. There are many applications and automated systems available that can be implemented and integrated to make the laboratory electronic. The problem is that do laboratories have the vision to do this? Many laboratories have major scientific applications such as LIMS, electronic laboratory notebooks and chromatography data systems but are they interfaced by paper and manual data input. The aim of this short course is to help attendees design an electronic environment that provides business improvements and regulatory compliance for laboratories in the pharmaceutical and allied industries.

Target Audience
Laboratory managers Senior analystical chemists IT and QA staff involved in implementing electronic working projects in the laboratory

Course Outline
The Electronic Laboratory: Concept and Principles 
Understanding and Improving Your Current Ways of Working  Workshop: Redesigning a Laboratory Process 
Planning and Implementing a Strategy for an Electronic Laboratory Workshop: Planning the strategy for a Laboratory to Transition from Paper to Electronic Working Workshops:  The Devil is in the Detail

Course Instructor's Biography
Bob McDowall is an analytical chemist with 40 years experience and 30 years experience of LIMS. 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. He is Principal of McDowall Consulting and was Visiting Research Fellow at the University of Surrey, UK from 1991 to 2001.