Module: Regulation and Data Analysis

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-ordinator	Semester 1: Margaret McCaul Semester 2: Margaret McCaul Autumn: Margaret McCaul
Module Teachers	Pat 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
Array

Description

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.

*Type*	*Hours*	*Description*
Workload	Full-time hours per semester
Online activity	21	Pre-recorded material and online activities.
Lecture	12	Weekly online synchronous lectures/tutorials
Lecture	3	Guest lecturers
Independent Study	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, ANOVA, non-parametric statistics and testing, linear & weighted regression, calibration curves, limit of detection, method of standard addition

Assessment Breakdown
Continuous Assessment	100%	Examination Weight	0%

Type	Description	% of total	Assessment Date
Course Work Breakdown
Loop Exam	Online 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
Assignment	Examining the student's knowledge of regulations, and their application to industry	50%	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

None

Update change for Susan Kelleher as module coordinator.

Programme or List of Programmes

AC	BSc in Chemical and Pharmaceutical Sc.
AI	Chemistry with Artificial Intelligence
AS	BSc in Analytical Science
BSSA	Study Abroad (DCU Business School)
BSSAO	Study Abroad (DCU Business School)
HMSA	Study Abroad (Humanities & Soc Science)
HMSAO	Study Abroad (Humanities & Soc Science)
IESA	Study Abroad (Institute of Education)
IESAO	Study Abroad (Institute of Education)
SHSA	Study Abroad (Science & Health)
SHSAO	Study Abroad (Science & Health)

Date of Last Revision

09-JUN-11

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