Certificate in Quality Assurance Essentials for Biopharmaceutical Manufacturing

Certificate in Quality Assurance Essentials for Biopharmaceutical Manufacturing

Course Overview 

This programme is designed to equip participants with the essential knowledge and skills required to excel in quality assurance within the manufacturing industry. Consisting of two specialised modules, this programme delves into critical aspects of manufacturing operations and quality assurance standards.
This programme is specifically designed for learners seeking a qualification that will enable them to either progress within their current employment or take up employment in a manufacturing operations industry.

Designed and delivered by highly experienced academics and industry professionals, our lecturers know the skills and knowledge that companies are looking for. Our unique part-time, online delivery allows learners to log on live or catch up by watching the recorded sessions which can also be used for revision. Extensive coaching and mentoring workshops will be provided with a specific focus on individual assessment and improvement.

The Certificate in Quality Assurance Essentials for BioPharma Manufacturing provides learners with an understanding of regulatory compliance and quality control in this highly regulated sector.
Learners will gain a foundational understanding of the theory and practical applications which are essential for this biopharmaceutical sector and will be equipped with a broad base skill set to gain entry level positions within this sector. Participants will study biopharmaceutical laboratory techniques, regulatory compliance, cGMP (current Good Manufacturing Practice), and will also delve into operational issues and deviations to identify root causes and potential solutions of digital strategies.

Accreditation

QQI Level 5 Special Purpose Certificate in Quality Assurance Essentials for Biopharmaceutical Manufacturing (30 FET)

Programme Delivery

This part time programme runs over 6 months. The programme is delivered in a blended format.
Lectures are delivered online during the week, with a number of in-person lectures taking place on various Saturdays throughout the programme.

Course Outline

The course duration is 6 months. This part-time programme is delivered in a blended format. Lectures are delivered online in the evenings, with a number of in-person lectures taking place on Saturdays throughout the programme.

Module 1: Cleanroom Operations and Plant Utilities/Facilities

• Facilities & Utilities Management Overview:
  – Efficient facility and utility management
  – Maintaining a controlled environment.
• Building Management:
  – Management of cleanroom buildings
  – Air pressure differentials, HVAC systems, and cleanroom construction materials
• Total Productive Maintenance – The benefits of TPM
  – Minimising unplanned downtime and operating at peak performance
• Introduction to Environmental Health & Safety Management:
  – Hazard identification, risk assessment, and mitigation strategies
  – The importance of safety measures
•  Introduction to Regulations:
  – The regulatory framework
  – Regulatory agencies, guidelines, and standards relevant to different industries
  – Legal and compliance

Module 2: Essentials of Quality Assurance

• Quality Management Systems (QMS):
  – The history and evolution of QMS
  – Regulations
  – Key concepts
  – GMP and compliance
• Documentation:
  – GDP – practical current guidelines
  – Technical writing
  – Data integritya
  – Case studies
• Health & Safety
  – Regulations
  – Hazards and risks
  – Risk assessment and management
  – Personal protective equipment (PPE)

Entry Requirements

Proficiency in English Language Required (B2+ level or equivalent on the Common European Framework or Reference for Languages (CEFR).

Why up-skill for the STEM process manufacturing sectors in Ireland

• €3 billion in new capital investment
• €39 billion in exports
• Over 55,000 employed
• 9 of top 10 world’s biopharma companies in Ireland
• 12 of the top-selling drugs made in Ireland
• Over 8,000 new jobs predicted