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 Certificate is composed of the following modules:
• Regulatory Affairs & Compliance Auditing (10 Credits Level 7)
• Cleanroom Management (5 Credits Level 7)
• Validation (5 Credits Level 7)
• Here is the make-up of the add-on Bachelor of Science in Quality (Ordinary) Degree (60 Credits, Level 7):
• Certificate in Quality (20 Credits, Level 7)
• 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)
• Certificate in Quality & Regulatory Affairs (20 Credits, Level 7)
• Regulatory Affairs & Compliance Auditing (10 Credits Level 7)
• Cleanroom Management (5 Credits Level 7)
• Validation (5 Credits Level 7)
• Certificate in Quality - Statistics & Management (20 Credits, Level 7)
• Production & Supervisory Management (5 Credits Level 7)
• Six Sigma for Quality Management (10 Credits Level 7)
• Project (5 Credits Level 7)

Learning Outcomes:

• Regulatory Affairs & Compliance Auditing
• Interpret the EU and FDA GMP guidelines and relevant ISO standards.
• Explain the legislative requirements during the various drug development and medical device development phases.
• Explain how a marketing authorization for pharmaceuticals and medical devices is obtained in the EU and the US.
• Detail the various approaches taken to compliance auditing.
• Detail a system for investigation of non-conformances, identification of root cause and corrective / preventive actions.
• Participate in an audit by interpreting relevant legislation and guidelines, identifying any non-conformances and recommend relevant corrective / preventive actions.

Cleanroom Management

• Identify the common sources of contaminants.
• Apply the fundamental steps of aseptic practice.
• Use a wide range of cleaning agents and know when to apply them.
• Define and apply the basis of cleaning validation.
• Work in a clean-room environment.
• Describe the basis of clean-room operation.
• Monitor the clean-room environment.
• Decontaminate the clean-room.
• Validation
• Explain the role of validation within Good Manufacturing Practice.
• Identify and apply the various validation guidelines and standards in use.
• Apply risk management tools as part of a validation exercise.
• Prepare a validation document in accordance with regulatory guidelines.
• Describe the major steps involved in the validation of critical pharmaceutical and medical device manufacturing operations.
• Describe the approach taken to analytical method validation.
• Complete various validation exercises.

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.

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.

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

Follow-on Studies:

• Certificate in Quality (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.