Module: Regulation & Data Analysis

Module Specifications.

Current Academic Year 2024 - 2025

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Date posted: September 2024

Module Title	Regulation & Data Analysis
Module Code	CS306 (ITS) / CHM1026 (Banner)
Faculty	Science & Health	School	Chemical Sciences
Module Co-ordinator	Margaret McCaul
Module Teachers	Blanaid White, Kieran Nolan, Patrick O'Malley, Susan Kelleher
NFQ level	8	Credit Rating	5
Pre-requisite	Not Available
Co-requisite	Not Available
Compatibles	Not Available
Incompatibles	Not Available

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: Resit category 1: A resit is available for both* components of the module. Resit category 2: No resit is available for a 100% continuous assessment module. Resit category 3: No resit is available for the continuous assessment component where there is a continuous assessment and examination element.
* ‘Both’ is used in the context of the module having a Continuous Assessment/Examination split; where the module is 100% continuous assessment, there will also be a resit of the assessment
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.