Certificate In Quality

Course details

The purpose of the Certificate in Quality is to provide the basic skills necessary to work in the area of Quality (e.g. Quality Inspector). The Certificate incorporates the learning outcomes of the Excellence Ireland Diploma in Quality Management. This Certificate, along with (a) the Certificate in Quality for Industry - Statistics & Management, and (b) the Certificate in Quality for Regulatory Affairs make up the add-on Bachelor of Science (Ordinary) Degree in Quality for Industry. It is possible to complete this Certificate in Quality and the Certificate in Quality & Regulatory Affairs within two academic years. You can then complete the Quality for Industry - Statistics & Management in a third year. Students who pass the assessments for the three modules, or who gain exemption from a module(s) with this Certificate (under GMIT's Recognised Prior Learning process) will obtain the Certificate. You can obtain any/all of three Certificates but to obtain the Bachelor of Science (Ordinary) Degree in Quality you must already hold a Higher Certificate (Level 6, 120 credits) in Business, Engineering or Science.

Programme Modules\

The make-up of the Certificate in Quality is:

• Quality Management 1/ Excellence Ireland Diploma in Quality Part 1 (10 Credits Level 7)
• Quality Management 2/ Excellence Ireland Diploma in Quality Part (10 Credits Level 7)

Syllabus:

Quality Management 1

• Differentiation between and importance of Quality Assurance and Quality Control.
• Introduction to Health and Safety legislation in the laboratory environment.
• The importance of the CAPA system in a GMP compliant company with case studies and interactive exercises in the latter.
• Documentation systems and the role of Standard Operating Procedures in a GMP compliant company (this section will encompass the draft of an appropriate SOP).
• Differentiation between GLP and GMP.
• Introduction to Quality Management Systems.
• Introduction to Validation and Qualification of processes, test methods, computers and equipment.
• Regulatory Agencies and Notified Bodies.

Quality Management 2

• Quality Systems: The evolution of Quality Systems, leading to Total Quality Management. ISO 9001 and I.S.O. 14000 Series Accreditation; Quality Tools.
• Good laboratory Practice (GLP): ISO 17025, Laboratory Information Management Systems (LIMS); Auditing; Qualified Person.
• Validation: Principles of Validation; Process Validation; Equipment Validation; Cleaning Validation; Validation of Analytical Methods.
• Good Manufacturing Practice (GMP): Incidents that accelerated the regulation of the pharmaceutical industry; Licenses required in the Pharmaceutical industry; EU GMP Guidelines.
• Regulatory Affairs: US and EU Regulatory bodies; regulations for pharmaceuticals.
• Health and Safety: Health and Safety Legislation; Hazard Identification and Risk Assessment in the laboratory; Safety Statements.