ITT Dublin www.ittdublin.ie Department of Science Part-time programme guide Lifelong Learning Certificate in Bio-processing and Cleanroom Management (Minor Award) Name of award: Certificate in Bio-processing and Clean Room Management (Minor Award) NFQ Level 6 Programme Code: TA_SMABP_C Duration: 1 semester Timetable: 2 evenings per week. Some modules may be delivered in blended mode –combination of class contact & distance learning. Date of commencement: September Programme Fee: For full details of the fees and timetable for each year of this programme please refer to our website www.ittdublin.ie or to the Quick guide to Part-time programmes guide for the current academic year About the Course To produce technically competent graduates who can work in Bio-pharmaceutical production, quality assurance or validation roles. They will possess knowledge of regulatory affairs, documentation and processing technologies, Biopharmaceuticals and Clean Room Management. The programme will offer those who have an interest in working in the Bio -pharmaceutical Industry a knowledge of the fundamentals of the appropriate sciences, the technology and its applications and an understanding of the Good Manufacturing Practice environment. The programme will offer those currently working in the industry an opportunity to acquire a foundation in the sciences relevant to industry and to develop a broad perspective of the issues which pertain to a bio-pharmaceutical manufacturing facility. This programme will run over one semester part-time. Candidates must take all modules on offer in the semester. Entry Level Mature students (Over 23 years) are eligible. Eligible candidates may be interviewed. All applicants must have competence in spoken and written English. Course Content Year 1 • Learning to Learn • Biology • cGMP1 & Quality Assurance • Introduction to Bio-processing • Contamination Control & Clean Room Mgmt Further Information Please visit: www.ittdublin.ie Programme Contacts: Dr Adrienne Fleming Tel: +353 1 404-2732 Email: adrienne.fleming@ittdublin.ie BSc Pharmaceutical Technology Named Award: BSc Pharmaceutical Technology Level 7 Programme code: TA_SPHAR_D Duration: 1.5 years Timetable: 2 evenings per week Commences: September Programme Fee: For full details of the fees and timetable for each year of this programme please refer to our website www.ittdublin.ie or to the Quick guide to Part-time programmes guide for the current academic year About the Course This programme is a follow-on to the Higher Certificate in Science – GMP & Technology. It aims to educate production, technicalgrade and supervisory/ managerial staff in fundamental and applied aspects of Good Manufacturing Practice, relevant core science and production management. It also allows some specialisation in finished dosage, or active pharmaceutical ingredient or biotechnology production. This programme will run over three semesters part-time. Candidates must take all modules on offer in each semester. This programme prepares operators working in the bio/pharmaceutical industry with the opportunity for improving their qualifications and preparing them for advancement into supervisory and/or management roles. Entry Level The minimum entry requirement is a Pass Award in the Higher Certificate in ScienceGMP & Technology programme or its equivalent. Candidates must be working in a relevant industry. All applicants must have competence in spoken and written English. Course Content Year 1 • Manufacturing and Process Technology II • Quantitative Methods • Elective 1 o API 1 o Process Biotechnology 1 o Pharmaceutical Formulations1 • Environmental Management • cGMP 3 • Production and Supervisory Mgt Year 2 • Technology Transfer • Project or Drug Discover Module • Elective 2 o API 2 o Process Biotechnology 2 o Pharmaceutical Formulations 2 Further Information Please visit: www.ittdublin.ie Programme Contacts: Dr Adrienne Fleming Tel: +353 1 404-2732 Email: adrienne.fleming@ittdublin.ie Higher Certificate in Science GMP & Technology Name of award: Higher Certificate in Science NFQ Level 6 Programme Code: TA_SGMPT_C Duration: 2 Academic Years Timetable: 2 evenings per week. Some modules may be delivered in blended mode –combination of class contact & distance learning. Date of commencement: September Programme Fee: For full details of the fees and timetable for each year of this programme please refer to our website www.ittdublin.ie or to the Quick guide to Part-time programmes guide for the current academic year About the Course To produce technically competent graduates who can work in production, quality assurance or validation roles. They will possess knowledge of regulatory affairs, documentation and processing technologies for oral dosage and aseptic finished pharmaceuticals as well as fine chemicals and biopharmaceuticals. The programme will offer those who have an interest in working in the Pharmaceutical Industry a knowledge of the fundamentals of the appropriate sciences, the technology and its applications and an understanding of the Good Manufacturing Practice environment. The programme will offer those currently working in the industry an opportunity to acquire a foundation in the sciences relevant to industry and to develop a broad perspective of the issues which pertain to a pharmaceutical manufacturing facility. This programme will run over four semesters part-time. Candidates must take all modules on offer in each semester. Entry Level Mature students (Over 23 years) are eligible. Eligible candidates may be interviewed. All applicants must have competence in spoken and written English. Course Content Year 1 • Learning to Learn • Biology • cGMP1 & Quality Assurance • Introduction to Pharmaceutical Science • Total Quality Mgmt • Maths • Contamination Control & Clean Room Mgmt Year 2 • Measurement Science • Chemistry • cGMP2 & Quality Control • Industrial Applications • Manufacturing & Processing Technology • Occupational Health & Safety Environment Mgmt • Introduction to Biopharmaceuticals Further Information Please visit: www.ittdublin.ie Programme Contacts: Dr Adrienne Fleming Tel: +353 1 404-2732 Email: adrienne.fleming@ittdublin.ie Please Note: Confirmation of modules being offered this year can be obtained from the School of Science & Computing Higher Diploma in Pharmaceutical Manufacturing Name of award: Higher Diploma in Science NFQ Level 8 Programme Code: TA_SPHAR_GD Duration: 18 months (3 semesters) Timetable: 2 evenings per week . Some modules may be delivered in blended mode –combination of class contact & distance learning. Date of commencement: September Programme Fee: For full details of the fees and timetable for each year of this programme please refer to our website www.ittdublin.ie or to the Quick guide to Part-time programmes guide for the current academic year Programme Outline & Aims This programme prepares science and engineering graduates for work in the bio/ pharmaceutical industry. It allows those already working in the industry to keep their skills fresh and prepares production-based personnel for advancement to supervisory and/ or management roles. Specific Aims: • To give science/engineering graduates an in-depth study of the specific requirements of the pharmaceutical industry with respect to production. • To give the student both a sound theoretical and practical grounding in the area. • To provide students with hands-on experience through assignments undertaken in the Institute’s Pharmaceutical Education Centre The programme consists of modules of direct relevance to the pharmaceutical industry as well as pharmaceutical and biopharmaceutical production. This programme will run over three college semesters (18 months) parttime. Candidates must take all modules on offer in each semester. Career Opportunities The bio and pharmaceutical industries in Ireland are currently undergoing a major expansion of scale and activity creating a wide range of career opportunities for interested and suitably qualified persons. Analysts suggest a shortage of well qualified graduates in the coming years which will add to the value placed upon qualifications such as this. Entry Requirements Candidates must possess a science, engineering or related primary degree (level 7). Experience in the pharmaceutical industry is desirable but not essential. All applicants must have competence in spoken and written English. Course Content Year 1 semester 1 • Pharmaceutical Processes I • Industrial Statistics • Regulatory Affairs & GMP Year 1 semester 2 • Pharmaceutical Processes II • Production Management • Systems Validation Year 2 semester 1 • Formulation Studies & Packaging • Aseptic Processing & Utilities How to Apply Apply online at www.it-tallaght.ie/parttimecourses More Information Information Desk, Department of Lifelong Learning. Tel: +353 1 404-2101 Email: lifelonglearning@ ittdublin.ie. Programme Leaders Dr Maureen Walsh. Tel: +353 1 404-2736 Email: maureen.walsh@ittdublin.ie Dr Ed Carey. Tel: +353 1 404-2769 Email: ed.carey@ittdublin.ien Certificate in GMP & Regulatory Affairs (Minor Award) Named Award: Certificate in GMP & Regulatory Affairs (Minor Award) NFQ Level 6 Programme code: TA_SMGRA_C Duration: 1 year Timetable: Distance Mode Commences: September Programme Fee: For full details of the fees and timetable for each year of this programme please refer to our website www.ittdublin.ie or to the Quick guide to Part-time programmes guide for the current academic year About the Course The aim of this programme is to produce technically competent graduates to work in production, quality assurance or validation roles. Those that complete the course will also possess knowledge of regulatory affairs, documentation, quality systems and quality control. The programme will offer those who have an interest in working in the Pharmaceutical Industry a knowledge an understanding of the Good Manufacturing Practice and the regulatory environment. The programme will offer those currently working in the industry an opportunity to acquire a foundation in the field of Regulatory Compliance. This programme will run over two semesters part-time. Candidates must take all modules on offer in each semester. Entry Level Mature students (Over 23 years) are eligible. Eligible candidates may be interviewed. All applicants must have competence in spoken and written English. Course Content Year 1 Learning to Learn • cGMP1 & Quality Assurance • Total Quality Mgmt • cGMP2 & Quality Control • cGMP 3 Further Information Please visit: www.ittdublin.ie Programme Contacts: Dr Adrienne Fleming Tel: +353 1 404-2732 Email: adrienne.fleming@ittdublin.ie Master Degree in Pharmaceutical Science (IMB Approved) Programme code not available yet Duration: 4 semesters Timetable: 2 evenings per week. Some modules may be delivered in blended modecombination of class contact and distance learning. Programme fee Full details of the fees and timetable for each year of the programme please refer to our website www.ittdublin.ie or go to the quick guide to part time programmes About the course The learners on this programme will hold Honours Degrees in disciplines specific areas In addition the learners will have completed a minimum of two years practical industrial experience in one or more undertakings which are authorised to manufacture proprietary medicinal/veterinary products. Specifically this experience will be in the activities of qualitative analysis of such products, of qualitative analysis of active substances and of the testing and checking necessary to ensure the quality of such products. It is expected that the learners will have attained the requisite knowledge, skills and competencies prescribed for Level 8 Honours Degree programmes. Furthermore it is expected that the learners will be familiar with the operation of a pharmaceutical manufacturing enterprise, the general need for quality assurance and some specific testing and checking protocols. Entry Requirements To be eligible for entry to the Masters in Science in Pharmaceutical Science the applicant requires a minimum of an honour in a level 8 honours degree qualification, awarded in a Member State of the EU, and a minimum of two years relevant work experience. Once the student has completed this programme of study, the Irish Medicines Board is the competent authority for the purpose of including an individual on a company’s drug manufacturing licence as a Qualified Person (QP). Applicants wishing to pursue the Masters qualification and whose company wishes to have the applicant designated as a Qualified Person on it’s manufacturing licence as issued by the Irish Medicines Board (i.e. applicants will be included on the Register to the IMB) Course content Year 1 Semester 1 Pharma Medicine & Analytical Chemistry Pharma Pro-Pre-F/Form Package Practical Course Semester 2 Process Chemistry Regulatory Affairs and GMP Pharmaceutical Biotechnology Aseptic Process and Utilities Bioprocess Technology Semester 3 Pharmacokinetics Pharma 1 Drug Uses Act and Tox Pharma 11 System Pharmacology Systems Validation Semester 4 Pharma and the Herbal Medicine QP Practices Thesis Further Information Visit www.ittdublin.ie Programme contact Dr Adrienne Fleming Tel: +353 1 4042732 Email: Adrienne.fleming@ittdublin.ie For more information go to www.ittdublin.ie MSc in Pharmaceutical Manufacturing and Process Technology Course Information To meet the manufacturing challenges of the 21st century a new MSc in Pharmaceutical Manufacturing and Process Technology is now being offered in partial distance mode using downloadable pre-recorded lectures and on line activities (lectures, discussions and tutorials). Another unique element of the MSc is the state of the art practical laboratory sessions in the latest PAT and Formulation Development techniques. Entry requirements are a level 8 qualification in a relevant science subject with honours. Applications without honours will be reviewed based on relevant experience and other qualifications. Bridging reading may be required for students not currently working in the industry. The course duration is over two semesters. Students have a choice of either undertaking a research thesis or attending advanced laboratory sessions. Lecture modules are typically delivered in 3 hour weekly blocks over the semester. Semester One Bio & Pharmaceutical Technology (online) Advanced Pharmaceutical Statistics (college) Advanced Laboratory Projects I (college) Thesis Semester Two Technology Transfer for Pharmaceutical Processes (online) Pharmaceutical Management and Quality Systems (online) Advanced Laboratory Projects II (college) Thesis Techniques covered in the syllabus and laboratory sessions include NIR, Raman, SEM, and Powder Rheometry. The inclusion of these techniques is due to the major injection of funding from Enterprise Ireland to equip and operate a new PAT research laboratory. This new laboratory is currently being used to assist pharmaceutical companies in product development and process control. The technical capabilities of the PAT laboratory are now integrated into the academic activities of the MSc. Other content of the MSc in Pharmaceutical Production focuses on challenges such as technology transfer, lean manufacturing, six sigma, project management and process control. The statistic module includes Design Space and Clinical Statistics together with practical sessions in the computer laboratory. The MSc offers a unique experience with a combination of on line activities and hands on practical experience. To maintain relevance the course is delivered using a combination of academic and industrial staff. The start date is September. Please contact Dr Ed Carey for any further information. Further Information Dr Ed Carey Course Leader, Senior Lecturer, ITT Dublin, Tallaght, Dublin 24. Ed.carey@ittdublin.ie Higher Certificate in Science – Contamination Control and Asepsis for the Healthcare Industry Formerly called –Higher Certificate in Science –Sterile Services Technology NFQ Level 6. Programme code TA_SSTSR_C Timetable: One day per week in college. Some modules may be delivered in blended mode a combination of class contact and distance learning. The Higher Certificate program runs over two years. Date of commencement September if numbers sufficient. Programme Fee: For full details of the fees and timetable for this program please refer to our website www. ittdublin.ie or to the quick guide to Part time programs guide for the current academic year. About the course: The major aims of the Higher Certificate program is to produce qualified and knowledgeable sterile service practitioners in a range of scientific, technological and quality activities in the health, hospital and related sectors. This course is designed to recognise the fact that the participants will already have gained invaluable work experience in this field. A key constraint on this industry’s growth is the continued supply and availability of skilled graduates. Companies still report difficulty in finding suitably qualified employees. There is a critical need for training programs to provide a qualified workforce for company expansions and for new manufacturing enterprises locating in Ireland. Entry Level Mature Students (Over 23) are eligible. Eligible candidates may be interviewed. All applicants must have competence in spoken and written English. Course content Year 1 Semester 1 Learning to Learn at Third Level Introduction to Medical Device Manufacture GMP1/Quality Assurance GMP2/Quality Control Process Improvement Bachelor of Science in Sterile Services Management Entry Level The course is designed for staff working in the healthcare industry. Name of award –Ordinary Degree in Science –Sterile Services Management NFQ Level 7. Programme code TA_SSTSR_D Timetable: One day per week in college. Some modules may be delivered in blended mode a combination of class contact and distance learning. The Ordinary Degree programme runs over one academic year. Date of commencement September. Further Information Please visit www.ittdublin.ie Program contacts John Behan Tel: 01-4042403 Email: john.behan@ittdublin.ie Programme Fee: For full details of the fees and timetable for this program please refer to our website www. ittdublin.ie or to the quick guide to Part time programs guide for the current academic year. Certificate in Good Manufacturing Practice and Medical Device(Minor Award) NFQ Level 6 Programme code not available yet Duration: 1 semester Timetable: 2 Evenings per week. Some modules may be delivered in blended modecombination of class contact and distance learning. Programme fee Full details of the fees and timetable for each year of the programme please refer to our website www.ittdublin.ie or to the quick guide to part-time programmes. About the course The medical devices industry is undergoing major changes globally as many new products enter the FDA approval pipeline. The move is for more high cost products to come to be manufactured in Ireland and there is also a move towards more combined products where medical devices are now being classified not just as medical devices but also as medicines. Ireland, because of its favourable tax regime for the manufacturing industry, the availability of a highly trained workforce, and its long track record in successfully supporting healthcare manufacturing has gained great economic benefits by continuing to attract many of the top manufacturers in the world to her shores. It is home to a growing number of medical devices, and healthcare companies. The medical devices sector is seeing changes to its product lines and regulatory requirements. About the course: The major aim of the Ordinary Degree programme is to build on the skills already acquired as a result of work experience and the completion of the level 6 Higher Certificate programme. The graduate at Ordinary Degree level will be qualified to work in a supervisory/ management role in the healthcare sector. It is envisaged that the participant will be already working in the healthcare sector Entry Level The course is designed for staff working in the sterile services or related areas. Candidates will be required to already have completed the Level 6 Higher Certificate in Science – Contamination Control and Asepsis for the Healthcare Industry. Further Information Please visit www.ittdublin.ie Program contacts John Behan Tel: 01-4042403 Email: john.behan@ittdublin.ie Tallaght Dublin 24 Telephone +353 1 4042000 Fax +353 1 404 2700 www.ittdublin.ie