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. The Certificate incorporates the learning outcomes of the Excellence Ireland Diploma in Quality Management. This Certificate, along with (a) the Certificate in Science 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. 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. The add-on Bachelor of Science (Ordinary) Degree in Quality for Industry is an add-on degree. You can undertake any/all inpidual module(s) and you can obtain any/all 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 2 (10 Credits Level 7) 

Learning Outcomes: 

Quality Management 1

• Discuss the role and function of Quality within the laboratory and Industry.
• Outline the role and function of GLP, Quality Assurance, GMP and Quality Control within the laboratory and industry.
• Identify the agencies which regulate quality standards.
• Identify the responsibilities of the employee and employer with regard to health and safety in the laboratory and industry.
• Construct non-conformance reports and CAPAs for breaches associated with Quality Systems in Biopharmaceutical Science companies.
• Design SOPs using laboratory standards and regulatory guidelines.

Quality Management 2

• Have a good knowledge of GMP, GLP, Validation, Regulatory bodies and Health & Safety regulations.
• Analyse and interpret the GMP guidelines and the legislation governing the manufacture of medicinal products in the EU.
• Assess and critically review work practices / facilities / equipment to ascertain compliance with various standards and the risk to safety of employees.
• Describe the concept of validation and its critical importance in the pharmaceutical industry.
• To work in a quality management role and participate in audits.
• To be familiar with regulatory bodies and licensing of pharmaceuticals
• Prepare and implement a safety statement in compliance with E.U. Directives and National legislation.

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.

Career Opportunities

The Excellence Ireland Diploma in Quality qualification helps operators move into Quality Inspector - type roles. The Bachelor of Science in Quality for Industry helps people obtain promotion to Line Leader/ Supervisor roles. 

Follow-on Studies: 

• Certificate in Quality & Regulatory Affairs (20 Credits, Level 7)
• Certificate in Quality - Statistics & Management (20 Credits, Level 7)
• Bachelor of Science (Ordinary) Degree in Quality

Entry requirements

There are no entry requirements to undertake this Certificate. But if having completed this and the other two Certificates in Quality you wish to obtain the add-on award, Bachelor of Science in Quality, you must hold a Higher Certificate in Business, Science or Engineering.