Registry

Module Specifications

Current Academic Year 2012 - 2013
Please note that this information is subject to change.

Module Title	Regulation and Data Analysis
Module Code	CS306
School	School of Chemical Sciences
Online Module Resources
Module Co-ordinator	Semester 1: Damian Connolly Semester 2: Damian Connolly Autumn: Damian Connolly
NFQ level	8	Credit Rating	5
Pre-requisite	None
Co-requisite	None
Compatibles	None
Incompatibles	None

Description

Part 1. To introduce students to the world of regulation, especially the areas of quality control, quality assurance and validation. To give an understanding of relevant guidelines and practices in relation to chemistry in industry. (Part 1 is taught conjointly with Regulation in CS312)Part 2.To introduce students to the most important and widely used statistical techniques for the evaluation of laboratory based data. The focus is to demonstrate the use of these techniques from a practical problem solving viewpoint and to acquaint them with the interpretation of the results arising from a statistical analysis. Particular emphasis will be placed on understanding the assumptions on which these statistical techniques are based and how to check or validate these assumptions.

Learning Outcomes

1. - describe and interpret the regulations for quality control, quality assurance and validation.
2. - apply these guidelines and practices in relation to chemistry in industry.
3. - apply statistical techniques for the evaluation of laboratory based data.
4. - validate the assumptions associated with statistical analysis.

Workload	Full-time hours per semester
*Type*	*Hours*	*Description*
Laboratory	18	computer laboratory session applying statistical methods to data sets
Lecture	12	Lectures
Lecture	6	Guest lecturers
Independent learning	89	Practising statistical analysis. preparing for lectures and guest lectures. reviewing and learning course material
Total Workload: 125

All module information is indicative and subject to change. For further information,students are advised to refer to the University's Marks and Standards and Programme Specific Regulations at: http://www.dcu.ie/registry/examinations/index.shtml

Indicative Content and Learning Activities

Regulation.
Quality Control Quality Assurance Method Topics covered will include validation , Process validation, The Food and Drug Administration (FDA), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Accreditation.

Data Analysis.
Topics covered will include significance testing, relative & fixed bias, precision, calibration- linear & weighted regression, detection of curvature, standard addition, limit of detection , repeatability /reproducibility and analysis of variance (one way).

Assessment Breakdown
Continuous Assessment	100%	Examination Weight	0%

Course Work Breakdown
Type	Description	% of total	Assessment Date
In Class Test	Examining the student's knowledge of regulations, and their application to industry	50%	Week 3
Open-book examination	Examining both the students choice of statistical test and application of statistical tools to evaluate analytical data	50%	Week 6

Reassessment Requirement
Resit arrangements are explained by the following categories; 1 = A resit is available for all components of the module 2 = No resit is available for 100% continuous assessment module 3 = No resit is available for the continuous assessment component
This module is category 2

Indicative Reading List

James M. Miller and Jonathan B. Crowther (Eds.). Wiley: 2000, Analytical Chemistry in a GMP Environment: A Practical Guide,
Good Laboratory Practice : The Why And the How.: 2005, Jurg P. Seiler, Springer Verlag,,
Good Manufacturing Practices for Pharmaceuticals.: 2006, Joseph D Nally, Informa Healthcare,
Principles and Practice of Pharmaceutical Medicine,: 2002, Andrew J. Fletcher, Lionel D. Edwards, Anthony W. Fox, Peter Stonier. Wiley,
Spreadsheet Applications in Chemistry: 1997, Diamond and Hanratty, Wiley Interscience,
Practical Curve Fitting and Data Analysis, Chemical and Information Systems Series,: 1993, Ellis HorwoodPTR Prentice Hall, Chichester,
Spreadsheet Chemistry: 1991, O.J. Parker, G. L. Breneman, Prentice Hall,
Concepts and Calculations in Analytical Chemistry a Spreadsheet Approach: 1992, H. Freiser, CRS Press,