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Module Specifications

Archived Version 2012 - 2013

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

Online Module Resources

Module Co-ordinatorDr. Blanaid WhiteOffice NumberX105
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
Laboratory18computer laboratory session applying statistical methods to data sets
Lecture12Lectures
Lecture6Guest lecturers
Independent Study89Practising 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 Assessment100% Examination Weight0%
Course Work Breakdown
TypeDescription% of totalAssessment Date
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
Unavailable
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,
Other Resources

None
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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