Foundation Level Certificate
Pharmaceutical Operations 

  • Course Overview
    This Foundation level course is designed to give participants a solid understanding of the key processes, procedures and technologies used within the Pharmaceutical, Biopharmaceutical and Medical Device industries. The program provides participants with the essential knowledge required to work within these industries, with core modules providing a grounding in Good Manufacturing Process (GMP), Quality Assurance, Tablet and Capsule Manufacturing, Bioprocessing, Medical Device Manufacturing and Pharmaceutical Facilities and Utilities. On completion of this course, learners will have developed specialised knowledge in range of subjects specifically related to developing a career in the (Bio) Pharmaceutical Industry and Medical Device sectors.
  • Module Information

    Introduction to Pharma Utilities, Facilities, HVACs and Cleanrooms

    This module examines the importance of maintaining a safe and fully operational environment within manufacturing areas: Pharma Utilities, Facilities, HVACs and Cleanrooms.  The online learning environment is designed to be educational, engaging, and above all, simple to use.  A short assessment follows this module.

    Learning Outcomes: 
    - Know the factors that affect facilities management, equipment and processes as applied in the pharmaceutical industry.
    - Understand the layout of a typical pharmaceutical site.
    - Roles and disciplines within facilities management.
    - Deep understanding of HVAC systems; how they work, their components and how important they are to the proficient maintenance of quality and maintaining a sterile environment within manufacturing areas, especially in the pharmaceutical industry.
    - An understanding of the intricacies of the equipment involved in providing a clean environment by being able to discuss the various filters involved in HVAC systems.
    - HVAC systems standards and how they maintain a sterile environment not only within the manufacturing area but also in the products themselves.
    - Be aware of simple factors which can have a dramatic effect on the quality of the work environment and the product that is being handled within it and measures taken to eliminate the risk of these incidents.
    - Design and functionality of Cleanrooms; how critical the operations and maintenance of facilities, HVAC systems and Cleanroom behavior are to the pharmaceutical industry.

    Overview of Tablet and Capsule Manufacturing and Packaging Processes

    This Innopharma module is an overview of Tablet and Capsule manufacturing and packaging processes. Tablet's and capsules are the most common form of finished drug.

    Learning Outcomes: 
    - Explain the basic steps and activities in drug discovery, development and clinical trials.
    - List different pharmaceutical dosage forms
    - Describe the different manufacturing processes for solid dose drug manufacturing
    - Describe the typical manufacturing processes for Biopharmaceutical drug manufacturing
    - Given a basic Process Map, identify the inputs, outputs and measures used to control drug quality


    This module will examine bioprocessing for the production of products. A bioprocess is the application of natural or genetically manipulated whole cells, tissues and organs, for production. This online learning environment is designed to be educational, engaging, and is simple to use.  An online assessment follows this module.

    Learning Outcomes: 
    - An understanding of how bioprocessing is applied in the pharmaceutical industry.
    - An overview of a typical bioprocessing environment
    - How to work effectively in a cleanroom without causing a risk to the product.
    - Furnish you with the science to succeed in the emerging technology-driven biotech industry.
    - Understand the technologies in the biopharmaceutical industry, including the creation and manufacture of products that help in the diagnosis and treatment of disease (e.g. the production of antibiotics, insulin and recombinant proteins).

    Quality Assurance and Good Manufacturing Practice

    This module is an introduction to Quality Assurance and Good Manufacturing Practice.  The short learning module is designed to give participants an overview of Good Manufacturing Practice (GMP) and the Quality System used in the manufacture of medicinal products. This online learning environment is designed to be educational, engaging, and above all, simple to use.  When this course has been completed a short online assessment can be taken

    Learning Outcomes: 
    - An understanding of Quality,  regulatory bodies and regulations.
    - Understand the purpose of the Pharmaceutical Quality Management System as well as a thorough knowledge of Quality System Elements. (QSEs)
    - Understanding of each Quality System Element of QA, Premises and Equipment, Calibration, Technology transfer and training.
    - Familiarity with the Quality System Elements in relation to Documentation, Supplier qualification and QC testing and stability.
    - Knowledge of Quality System Elements of Validation, Change Control, Investigations and CAPA.

  • Lecturers

    Paul Rooney

    Mike Mulcahy

    Luke Kiernan

    Luke has over 20 years of experience within the pharmaceutical manufacturing industry, having previously worked with Pfizer, Wyeth, Elan and Gerard Laboratories. Luke has held various management roles, in Technical Services, Validation, Process Development, Regulatory Affairs, Analytical Development, Quality Control and Quality Assurance. Luke holds a BSc in Chemistry from the University of Glamorgan and an MSc in Instrumental Methods of Analysis from Dublin City University

  • Career Options

    Career Opportunities

    • Production Operator/Technician 
    • Maintenance Operator 
    • Quality Assurance 
    • Packaging Operator 
    • Product Builder 
    • Support/Administrator

  • Course Fees

    € 650.00

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