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Module Specifications..

Current Academic Year 2023 - 2024

Please note that this information is subject to change.

Module Title Regulation and Data Analysis
Module Code CS306
School School of Chemical Sciences
Module Co-ordinatorSemester 1: Margaret McCaul
Semester 2: Margaret McCaul
Autumn: Margaret McCaul
Module TeachersPat O'Malley
Blanaid White
Kieran Nolan
Margaret McCaul
Susan Kelleher
NFQ level 8 Credit Rating 5
Pre-requisite None
Co-requisite None
Compatibles None
Incompatibles None
Coursework Only

Regulation: 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. Data Analysis: 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
Online activity21Pre-recorded material and online activities.
Lecture12Weekly online synchronous lectures/tutorials
Lecture3Guest 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

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, ANOVA, non-parametric statistics and testing, linear & weighted regression, calibration curves, limit of detection, method of standard addition

Assessment Breakdown
Continuous Assessment100% Examination Weight0%
Course Work Breakdown
TypeDescription% of totalAssessment Date
Loop ExamOnline exam or assignment that will cover the students knowledge of and ability to apply a range of data analysis approaches to different problems.50%Week 7
AssignmentExamining the student's knowledge of regulations, and their application to industry50%Week 8
Reassessment Requirement Type
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 1
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,
  • James N. Miller, Jane C. Miller: 2010, Statistics and Chemometrics for Analytical Chemistry, 6th, Pearson, England, 9780273730422
Other Resources

Update change for Susan Kelleher as module coordinator.
Programme or List of Programmes
ACBSc in Chemical and Pharmaceutical Sc.
AIChemistry with Artificial Intelligence
ASBSc in Analytical Science
BSSAStudy Abroad (DCU Business School)
BSSAOStudy Abroad (DCU Business School)
HMSAStudy Abroad (Humanities & Soc Science)
HMSAOStudy Abroad (Humanities & Soc Science)
IESAStudy Abroad (Institute of Education)
IESAOStudy Abroad (Institute of Education)
SHSAStudy Abroad (Science & Health)
SHSAOStudy Abroad (Science & Health)
Date of Last Revision09-JUN-11

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