OPER H6001. Pharmaceutical Operations Mgt. APPROVED. Pharmaceutical Operations Management for Engineers. Credits: 5. NFQ Level: 9

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1 Short Title: Full Title: APPROVED Management for Engineers Module Code: OPER H6001 Credits: 5 NFQ Level: 9 Field of Study: Mechanics and metal work Module Delivered in 1 programme(s) Reviewed By: GERARD RYDER Module Author: HUGH CLAFFEY Module Description: To provide engineering students with an organisational structure for the management of pharmaceutical operations in the areas of validation, process control and regulation Learning Outcomes On successful completion of this module the learner will be able to: LO1 LO2 LO3 LO4 LO5 LO6 Design and interpret a pharmaceutical risk assessment Understand the requirements and implications of a pharmaceutical facility GMP inspection Apply the ICH guidelines to design a Pharmaceutical Management structure Validate GMP critical systems and processes Devise and interpret process validation documentation Apply regulatory guidelines to pharmaceutical manufacturing automation systems Pre-requisite learning Co-requisite Modules No Co-requisite modules listed

validation, process control and regulation Learning Outcomes On successful completion of this module the learner will be able to: LO1 LO2 LO3 LO4 LO5 LO6 Design and interpret a pharmaceutical risk

2 Module Content & Assessment Content (The percentage workload breakdown is inidcative and subject to change) % Pharmaceutical Management Structure Management systems compliant with best practice and current regulations. Use of ICH guidelines. Applications of Risk Management. CAPA and Six Sigma Regulatory Inspections IMB/FDA GMP facility inspections and GDP Rick Management Identify, assess and prioritize risks in a pharmaceutical manufacturing environment Process Validation QbD approach, Risk Management, ASTM 2500, ICH Q8,9 &10, CQAs, CPPs, biopharmaceutical, API and solid dosage processes, medical device manufacturing processes. Validation of GMP critical utilities Regulatory requirements and guidelines, sampling plan and frequency tests IQ, OQ and PQ requirements of HVAC, USP and WFI water, compressed gases and clean steam. Automated manufacturing process validation for pharmaceutical manufacturing Regulatory standards and guidelines; EU GMP Annex 11, FDA CFR 21 part 11, GAMP/lifecycle approach, documentation requirements % 20.00% Assessment Breakdown % Course Work 30.00% End of Module Formal Examination 70.00% Course Work Assessment Type Assessment Description Outcome addressed % of total Assessment Date Using FMEA case studies, identify, assess and prioritize risks in a pharmaceutical environment. Using WHO Case studies in GMP inspections, carry out an ad udit techniques, reference 21 CFR Part 11, GAMP Preparation of Marketing Authorization Applications and associated variations and renewals. Comparison of EU, PIC/S and FDA policy and procedures n/a n/a 5, n/a End of Module Formal Examination Assessment Type Assessment Description Outcome addressed % of total Assessment Date Formal Exam End-of-Semester Final Examination 1,2,3,4,5, End-of-Semester Reassessment Requirement Repeat examination Reassessment of this module will consist of a repeat examination. It is possible that there will also be a requirement to be reassessed in a coursework element. IT Tallaght reserves the right to alter the nature and timings of assessment

CAPA and Six Sigma Regulatory Inspections IMB/FDA GMP facility inspections and GDP Rick Management Identify, assess and prioritize risks in a pharmaceutical manufacturing environment Process

3 Module Workload Workload: Full Time Workload Type Workload Description Hours Frequency Average ly Learner Workload Lecture theory,, case studies, 3.00 Every Independent Learning supplemental reading, preparation of assignments 5.00 Every Total ly Learner Workload 8.00 Total ly Contact Hours 3.00 Workload: Part Time Workload Type Workload Description Hours Frequency Average ly Learner Workload Lecture theory, case studis 3.00 Every Independent Learning Time supplemental reading, preparation of assignments 5.00 Every Total ly Learner Workload 8.00 Total ly Contact Hours 3.00

4 Module Resources Recommended Book Resources Hamid Mollah, Harold Baseman, Mike Long, 2001, Application of Risk Management for Pharmaceutical and Biological Products Manufacturing, Wiley [ISBN: ] James L. Vesper, 2006, Risk Assessment and Risk Management in the Pharmaceutical Industry, GMP publishing [ISBN: ] Jackelyn Rodriguez, 2011, Capa in the Pharmaceutical and Biotech Industries, Biohealthcare Publishing [ISBN: ] edited by Joseph F. despautz 1998, Automation and validation of information in pharmaceutical processing, Marcel Dekker New York [ISBN: ] Stephen Robert Goldman, 2003, Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry [ISBN: ] 2008, The GAMP Guide for Validation of Automated Systems [ISBN: ] Required Article/Paper Resources ICH 2011, ICH Q9 Quality Risk Management ICH 2008, ICH Q10 Pharmaceutical Quality System FDA 2009, White paper FDA Guidance for Industry update Process Validation, Pharmaceutical Engineering, 29 no 3 GHTF 2004, Quality Management Systems - Process Validation Guidance, Global Harmonisation Taskforce Guidelines This module does not have any other resources

Vesper, 2006, Risk Assessment and Risk Management in the Pharmaceutical Industry, GMP publishing [ISBN: 1930114907] Jackelyn Rodriguez, 2011, Capa in the Pharmaceutical and Biotech Industries,

5 Module Delivered in Programme Code Programme Semester Delivery TA_EAMEC_M Master of Engineering in Mechanical Engineering 9 Mandatory

IMDE H3000: Interactive Marketing Design

IMDE H3000: Interactive Marketing Design Short Title: Full Title: Interactive APPROVED Interactive Module Code: IMDE H3000 Credits: 5 NFQ Level: 7 Field of Study: Marketing and advertising Module Delivered in 2 programme(s) Reviewed By: ADRIAN