Course Information
Course Title: Raw Data, Results and Reportable Values; A Compliant Approach to QC Laboratory Data Management
Categories: 1 - Pharmaceutical Sciences
2 - Data Analysis
3 - Data Management
4 - Quality/Regulatory/Compliance
5 - Validation
Instructor(s): Christopher Burgess, Bob McDowall Course Number: 127
Affiliation: Burgess Analytical Consultancy Limited
Course Date: 03/13/2012 - Tuesday Course Length: 2 Day Course
Start Time: 08:30 AM End Time: 05:00 PM
Course Date 2: 03/14/2012 - Wednesday    
Start Time: 08:30 AM End Time: 05:00 PM
Fee: $900 ($1300 after 2/13/12) Textbook Fee:

Course Description
Demonstrating the integrity and security of laboratory data, records, results and information is paramount for a successful audit or inspection for any GMP regulated quality control laboratory. US GMP regulations state that “Laboratory records shall include complete data derived from all tests necessary to assure compliance with established specifications and standards, including examinations and assays, as follows: …..”. As a result of the increase in fraud and data falsification detected during inspections, the FDA has developed Compliance Program Guide 7346.832 for Pre-Approval Inspections which will be fully implemented in May 2012. One objective of this CPG is the data integrity audit directly impacting QC laboratories. In addition the European Union has just made a new law (2001/62/EU) regarding the security of global pharmaceutical supply chain which includes contract laboratories. The course will be based on the life cycle of a laboratory record and look at the integrity and security of it throughout its life time. We will discuss paper records as well as hybrid systems and electronic records. This 2 day course, a combination of lectures and linked workshops, has the following objectives: 1. To present the regulatory requirements and relevant critical regulatory observations concerning laboratory data integrity and security. 2. To provide attendees with the tools and techniques to define “complete data” in the context of paper, hybrid and electronic records to ensure the integrity and security of laboratory records regardless of the mode of generation. 3. To provide understanding of best practices in the life cycle of laboratory records

Target Audience
This 2 day course with associated workshops is designed for analytical chemists, senior technicians and laboratory managers with the day to day management and evaluation of laboratory data in a regulated environment. QA and regulatory affairs professionals will benefit by gaining a clear understanding of the latest FDA & USP and European requirements.

Course Outline
1. Introduction to the Course with Course Roadmap
2. EU and FDA GMP Regulations Impacting Laboratory Data and Results
3. Fat Finger, Falsification or Fraud?
4. Principles for the Generation of Data with associated Workshop
5. Recording of Data with associated Workshop
6. Transforming Data with associated Workshop
7. Collation and reporting of results with associated Workshop
8. Archiving

Course Instructor's Biography
Dr Burgess is a Chartered Chemist and has more than 36 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 has been appointed to the United States Pharmacopoeia’s Council of Experts 2010 to 2015 and 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. Co Presenter Dr Bob McDowall