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Module Specifications

Archived Version 2010 - 2011

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

Online Module Resources

Module Co-ordinatorDr. Blanaid WhiteOffice NumberX105
Level 3 Credit Rating 5
Pre-requisite None
Co-requisite None
Module Aims
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. 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)

Learning Outcomes
Part 1.
Students will gain an appreciation of regulation and how it impacts on all operations in the pharmaceutical, environmental, food 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 students to work in all regulated environments in industry.

Part 2.
Students should be able to evaluate a set of results and infer as to whether a statistically significant conclusion may be drawn from a data set. They should have a good understanding of the options available to them to improve the accuracy and precision and to minimise the uncertainty of results arising from the application of a particular test method. The course should foster a critical attitude towards experimental data collection and analysis.

Indicative Time Allowances
Hours
Lectures 30
Tutorials 0
Laboratories 6
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
Assessment
Continuous Assessment100% Examination Weight0%
Indicative Reading List
Recommended:
  1. Analytical Chemistry in a GMP Environment: A Practical Guide, James M. Miller and Jonathan B. Crowther (Eds.). Wiley, 2000. DCU library ref. 65.190685
  2. Good Laboratory Practice : The Why And the How. Jurg P. Seiler, Springer Verlag, 2005. DCU library ref. 610.284
  3. Good Manufacturing Practices for Pharmaceuticals. Joseph D Nally, Informa Healthcare, 2006. DCU library ref. 338.476151
  4. Principles and Practice of Pharmaceutical Medicine, Andrew J. Fletcher, Lionel D. Edwards, Anthony W. Fox, Peter Stonier. Wiley, 2002. DCU library ref. 615.19
  5. Diamond and Hanratty: Spreadsheet Applications in Chemistry, Wiley Interscience, 1997, ISBN0471-14987-2
  6. P.W. Atkins, Physical Chemistry, 5th ed., 1994, Oxford University Press.
  7. H.H. Willard, Instrumental Methods of Analysis, 7th ed. 1988, Wadsworth Publishers.
  8. J.H. Noggle, Practical Curve Fitting and Data Analysis, Chemical and Information Systems Series, Ellis Horwood-PTR Prentice Hall, Chichester, 1993.
  9. O.J. Parker, G. L. Breneman, Spreadsheet Chemistry, 1991, Prentice Hall Inc., Englewood Cliffs, N.J., 1991.
  10. H. Freiser, Concepts and Calculations in Analytical Chemistry - a Spreadsheet Approach', CRS Press, Boca Raton, 1992.
Programme or List of Programmes
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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