Certificate in Quality Assurance Essentials for Biopharmaceutical Manufacturing

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 integrity
  – Case studies
• Health & Safety
  – Regulations
  – Hazards and risks
  – Risk assessment and management
  – Personal protective equipment (PPE)