Short Course Listings
Short Course

Course Information
Course Title: Analytical Excellence: Assuring Data Integrity and Laboratory Compliance
Categories: 1 - Analytical Metrology
2 - Laboratory Information and Management
3 - Management/Professional Development
4 - Data Management
5 - Quality/Regulatory/Compliance
6 - Validation
Instructor(s): Christopher Burgess, Bob McDowall Course Number: 98
Affiliation: B A C Limited
Course Date: 03/05/2016 - Saturday Course Length: 2 Day Course
Start Time: 08:30 AM End Time: 05:00 PM
Course Date 2: 03/06/2016 - Sunday    
Start Time: 08:30 AM End Time: 05:00 PM
Fee: $1050 ($1450 after 2/12/16) Textbook Fee:

Course Description
Regulated laboratories are subject to intense scrutiny by FDA and other global regulatory authorities. At the same time companies are under pressure to reduce costs whilst maintaining compliance. Recent disclosures of fraudulent data practices and quality system failures have resulted in large fines and import bans. The purpose of this 2 day intensive and practical course is to; • Describe a framework to ensure analytical excellence in the laboratory which minimises compliance risk and maximises the use of best practices • Review the critical areas of laboratory regulatory compliance from an FDA standpoint as well as global regulatory bodies such as WHO, ISO 17025 and PIC/S • Discuss a lifecycle frame work for the laboratory and identify best practices • Allow attendees to reinforce the key learning points through workshops and case studies

Target Audience
Managers and scientists from Quality Control and Analytical Development Laboratories Quality Assurance personnel Regulatory Affairs personnel with responsibility for the laboratory submissions and variations Auditors (internal and external) responsible for assessing laboratory results and GMP compliance

Course Outline
1. Introduction to Course and charting of participant learning objectives (Interactive discussion)
2. Fundamentals of Analytical Excellence (Presentation)
3. Regulatory requirements overview (Presentation)
4. Data integrity & security: the Analytical 'factory' framework (Presentation)
5. An integrated approach to the Analytical Instruments & Systems Lifecycle (Presentation)
6. How much do I need to do? (Interactive workshop)
7. Analytical Procedures Lifecycle (Presentation)
8. Audit of an Analytical Procedure & Documentation (Interactive workshop)
9. Control under a Quality Management System (Presentation)
10. Deviation management case studies (Interactive workshop)
11. Data security & archiving (Presentation)
12. Analytical Excellence; Key learning points

Course Instructor's Biography
Dr Burgess is a Chartered Chemist and has more than 40 years experience in the pharmaceutical industry primarily with Glaxo (now GSK )in Quality Control, Quality Assurance and Analytical R&D. He is a “QP”, Qualified Person, in the European Union and a member of the European QP Association advisory board. He was appointed to the United States Pharmacopoeia’s Council of Experts 2010 to 2015 and 2015 to 2020. He is a visiting professor of the University of Strathclyde’s School of Pharmacy and Biomedical Sciences (SIPBS). In addition, he is the chairman of the ECA Analytical Quality Control Group and a member of the Executive committee of European Compliance Academy. He is also a Chartered European Chemist, a Chartered Scientist and a qualified ISO Guide 17025 assessor and was a member of the PDA Expert Working Group on Out of Specification results. He is an editorial board member of Pharmaceutical Technology and author of the Statistical Solutions column. Dr Bob McDowall is an analytical chemist with over 40 years experience including 15 years working in the pharmaceutical industry and 20 years working for the industry as a consultant. He is Principal of McDowall Consulting, UK. Bob is an ISO 17025 assessor and he has been involved with the validation of computerised systems for over 20 years and is the author of a book on the validation of chromatography data systems. Bob is also the writer of the Questions of Quality (LC-GC Europe) and Focus on Quality (Spectroscopy) columns and is a member of the Editorial Advisory Boards of several Journals.