Certificate In Quality & Regulatory Affairs

Course details

The purpose of the Certificate is to provide the student with the basic skills necessary to work in the area of Quality within the pharmaceutical / medical device industries, specifically the Regulatory Affairs aspects of those industries.This Certificate, along with (a) the Certificate in Science in Quality for Industry - Statistics & Management, and (b) the Certificate in Quality make up the add-on Bachelor of Science (Ordinary) Degree in Quality for Industry. It is possible to complete this Certificate in Quality & Regulatory Affairs and the Certificate in Quality 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 individual 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 makeup of the Certificate in Quality & Regulatory Affairs is:

• Regulatory Affairs & Compliance Auditing (10 Credits Level 7)
• Cleanroom Management (5 Credits Level 7)
• Validation (5 Credits Level 7)

Syllabus:

Regulatory Affairs & Compliance Auditing

• Pharmaceutical and Medical Device regulatory affairs - legislation and guidelines.
• Quality Management systems that ensure compliance with relevant legislation and guidelines.
• Marketing authorization processes for medical devices and pharmaceuticals.
• Audit methodologies and tools.
• Interpretation of GMP and ISO guidelines.
• Case studies - performance of audits, audit reporting.&
• Actions to rectify non-conformances - identification of root cause, corrective actions, preventive actions.

Cleanroom Management

• Clean-room classifications and standards. Types of clean-rooms, their location within buildings and their various applications in the pharmaceutical industry. Analysis of the fundamentals of air filtration: principles of HEPA filtration and design of HEPA systems and ventilators. Systems of air classification: Federal Standard 209. B.S. 5295. ISO standards etc.
• Selection of walls, ceilings, floor material and equipment. Barrier/Isolator technology. Air showers, weighing cabinets and material pass-through corridors.
• Clothing and housekeeping practices for the clean room staff and maintenance contractors. Critical control of clean-room entrance practices. Standard Operating Procedures for clean-room work. /li>
• Monitoring the quality of materials entering the clean-room. Monitoring air and surface quality in clean-rooms. Monitoring decontamination procedures used in clean-rooms. Clean-room standards for designating normal, alert and alarm levels.
• Introduction to specialized methods of cleaning and decontaminating clean-rooms. Introduction to positive air pressure environments and their use in segregating working areas within clean-rooms. Review of personal behaviour in clean rooms and how this influences clean-room contamination.
• The nature of contamination; physical, chemical and biological residues. Examination of sources of residues and how residues are transported within the work environment. Problems caused by the presences of contaminating residues in pharmaceutical processes. Materials/equipment compatibility and contamination of pharmaceuticals. /li>
• Selection of cleaning agents and items of equipment in use in the pharmaceutical manufacturing sector. Criteria used in the selection of appropriate cleaning agents and equipment.
• Principles of effective cleaning. Understanding the chemistry of cleaning. Writing standard operating procedures describing controlled cleaning practices. Disinfectant effectiveness testing, testing the effectiveness of cleaning agents. Practical monitoring the effectiveness of cleaning regimes. And disinfectants. Cleaning validation made simple.
• Review of good housekeeping practices, procedures and barrier technology used in the control of contamination in pharmaceutical manufacturing facilities. Analysis of facility design and its influence on the spread of contaminants.

Validation

• Regulatory basis for validation
• Risk management and its role in validation including review of ISO 1497
• Equipment validation - DQ, IQ, OQ, PQ.
• Pharmaceutical process validation
• Analytical method validation and Good Automated Manufacturing Practice
• Validation of medical devices including key processes including sterilisation
• Change Control