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Module Specifications

Archived Version 2006 - 2007

Module Title Regulation and Data Analysis
Module Code CS306
School School of Chemical Sciences

Online Module Resources

Module Co-ordinatorProf Dermot DiamondOffice NumberL2 39B
Module Co-ordinatorProf Dermot DiamondOffice NumberL2. 39B
Level 3 Credit Rating 5
Pre-requisite None
Co-requisite None
Module Aims
Part 1. To develop spreadsheet skills as an aid for performing complex calculations and graphing functions. To enable students to use spreadsheets for processing experimental data and investigating theoretical models. To use the optimisation add-in 'Solver' to perform complex least squares non-linear curve fitting . To de-mystify non-linear equations through visualisation and flexible parameter variation. To interpret experimental data in a statistically robust manner. To automate repetitive operations using Macros. Part 2. To introduce students to the world of regulation, especially the areas of quality control, quality assurance, validation and to give them an understanding of relevant guidelines and practices in relation to chemistry in industry. (Part 2 is taught conjointly with Regulation in CS312)

Learning Outcomes
Part 1. Students should be able to: - graphically display and process data captured from instrumentation. - extract information from data (data reduction techniques). - use spreadsheets to graph complex functions - perform curve fitting to experimental data. - assess the suitability of different data processing approaches (problem solving). - develop a critical attitude to experimental data analysis Part 2. Students will gain an appreciation of regulation and how it impacts on all operations in the pharmaceutical and other industries. They will also learn how the work of analytical scientists and chemists is affected by and important in the areas of quality control, quality assurance, validation, Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and accreditation. This will help them to work in all regulated environments in industry.

Indicative Time Allowances
Hours
Lectures 20
Tutorials 0
Laboratories 16
Seminars 0
Independent Learning Time 39

Total 75
Placements
Assignments
NOTE
Assume that a 5 credit module load represents approximately 75 hours' work, which includes all teaching, in-course assignments, laboratory work or other specialised training and an estimated private learning time associated with the module.

Indicative Syllabus
Part 1. a) Computing workshop covering topics such as: Data filtering and feature extraction, Curve fitting - linear regression and non-linear regression - with models that are built in to Microsoft Excel.Advanced curve fitting - fitting user-generated models to experimental data.Assessment of fit - examination and interpretation of residuals.Matrix algebra - use of matrix inversion to determine the composition of mixtures Part 2. a) Quality Control b) Quality Assurance c) Method validation d) Process validation e) The Food and Drug Administration (FDA) f) Good Manufacturing Practice (GMP)g) Good Laboratory Practice (GLP) h) Accreditation
Assessment
Continuous Assessment100% Examination Weight0%
Indicative Reading List
Essential: 1) Diamond and Hanratty: Spreadsheet Applications in Chemistry, Wiley Interscience, 1997, ISBN0471-14987-2 Supplementary: 1) Analytical Chemistry in a GMP Environment: A Practical Guide, James M. Miller and Jonathan B. Crowther (Eds.). Wiley, 2000. DCU library ref. 615.190685 2) Principles and Practice of Pharmaceutical Medicine, Andrew J. Fletcher, Lionel D. Edwards, Anthony W. Fox, Peter Stonier. Wiley, 2002. DCU library ref. 615.19 3) Handbook of Modern Pharmaceutical Analysis, A Volume in the Separation Science and Technology Series, Ahuja Satinder and Stephen Scypinski. Academic Press, 2001. DCU library ref. 615.1901 4) P.W. Atkins, Physical Chemistry, 5th ed., 1994, Oxford University Press. 5) H.H. Willard, Instrumental Methods of Analysis, 7th ed. 1988, Wadsworth Publishers. 6) J.H. Noggle, Practical Curve Fitting and Data Analysis, Chemical and Information Systems Series, Ellis Horwood-PTR Prentice Hall, Chichester, 1993. 7) O.J. Parker, G. L. Breneman, Spreadsheet Chemistry, 1991, Prentice Hall Inc., Englewood Cliffs, N.J., 1991. 8) H. Freiser, Concepts and Calculations in Analytical Chemistry - a Spreadsheet Approach', CRS Press, Boca Raton, 1992.
Programme or List of Programmes
ACBSc in Chemical and Pharmaceutical Sc.
ASBSc in Analytical Science
BSSAStudy Abroad (DCU Business School)
BSSAOStudy Abroad (DCU Business School)
ECSAStudy Abroad (Engineering & Computing)
ECSAOStudy Abroad (Engineering & Computing)
HMSAStudy Abroad (Humanities & Soc Science)
HMSAOStudy Abroad (Humanities & Soc Science)
SHSAStudy Abroad (Science & Health)
SHSAOStudy Abroad (Science & Health)
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