Advanced Certificate
Pharmaceutical Operations

  • Course Overview
    This Advanced 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, providing a grounding in CGMP, Quality Assurance, Tablet and Capsule Manufacturing, Bioprocessing, Medical Device Manufacturing and Pharmaceutical Facilities and Utilities. In addition, this advanced program will provide learners with further specialised industry knowledge of Validation, Clinical Research and Process Analytical Technologies with a view to advancing a career within (Bio) Pharmaceutical Industry and Medical Device sectors.
  • Module Information

    Medical Devices

    This Innopharma Module is on Medical Devices, which is a significant and growing global industry.  Devices can range from a single band-aid to an MRI scanner. Medical devices are designed and manufactured, subject to regulation regardless of their simplicity or complexity. This module looks at these processes and the importance of good manufacturing practice. This online learning environment is designed to be educational engaging and above all simple to use. When this module is completed, an online assessment follows.

    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.

    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

    Process Analytical Technologies

    This module is an introduction to Process Analytical Technologies (PAT).

    Learning Outcomes: 
    - Introduction to Quality by Design
    - Introduction to Process Analytical Technology
    - PAT Regulations
    - The Reasons for PAT
    - The Implementation of PAT
    - PAT Technologies
    - Real-Time release and Impact to Quality Systems
    - Benefits of PAT


    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).

    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.


    This course is designed to give you an overview of Validation Master Planning and the Validation of systems & processes.  This online learning environment is designed to be educational, engaging, and above all, simple to use.  A short online assessment follows the module. 

    Learning Outcomes: 
    - Why we validate and the Regulatory requirements surrounding the manufacture of medicinal products.
    - Validation master planning and documentation
    - GMP facility, equipment and utility qualification
    - Validation design, verification and qualification
    - Process validation
    - Cleaning Validation
    - Pharma GMPs for the 21st century
    - Post validation activities and maintaining the validation status

    Clinical Research

    This Innopharma module examines the process of clinical research and its importance to researchers, regulators and, patients. After this module, a short online assessment follows.

    Learning Outcomes: 
    -  Map the process of clinical research, its importance to the researchers, the regulators, trial subjects  and ultimately those who use the drug and therapies – the Patient
    - Understand the key factors which affect the $1 trillion + industry today and the current trends which influence its rapid development and growth.
    - Be able to discuss the different treatments which are constantly being developed and improved to fight common conditions such as heart disease, stroke and cancers. Become familiar with Drug therapy areas including allergy and immunology , cardiovascular and metabolic disorders, neuroscience treatments, infectious disease treatment, oncology and vaccines.
    - Be able to walk through the processes of Drug Discovery and  Drug Development.
    - Understand in detail the process of pre-clinical and clinical trials, the role of regulatory authorities in testing and assessment of quality, efficacy and safety of drugs.
    - Clear understanding of Pharmacovigilance and its role in the detection, assessment, understanding and prevention of adverse effects. Members of the academy will learn of its reach to herbs, traditional and complementary medicines, blood products, biological, medical devices and vaccines. 
    -  Regulations and Ethics of getting drug therapies to the market and their relevance to patient safety.

  • Lecturers

    Finbarr Sheehy

    Finbarr has over 25 years of experience at senior levels within the Semiconductor and Pharmaceutical industries. He was Director of Continuous Improvement & Training with Wyeth, Newbridge, Co. Kildare, Ireland. Prior to Wyeth, he was Skills Training Manager, with Intel Ireland, Co. Kildare. He also held the position of Test Development Engineer with Analog Devices Incorporated, Limerick. In 2008 he established and currently works with businesses across several sectors (including Pharma) in Ireland to drive business improvements.

    Ian Jones

    Dr. Ian Jones is the Founder and CEO of the Innopharma Group. He has worked for the past 20 years within the (bio) pharmaceutical and food manufacturing sectors where he has become a global leader in particle science, process robustness and advanced process control. He has a PhD in Process Analytical Technologies from Technological University Dublin and has studied Strategy, Leadership and Innovation within the Pharmaceutical Industry at the Harvard Business School, Boston and Accelerated Growth Strategies at Judge Business School, Cambridge, UK.

    Sean Costello

    Dr Costello leads the Technical Group of Innopharma in the development of real-time non-contact imaging technologies for monitoring and control of processes in pharmaceutical, food and chemical industries. Prior to joining Innopharma, Dr Costello was Site Manager for Leica Biosystems Ireland, a leading pathology diagnostics company and part of Danaher Corp. Dr Costello was a founder of SlidePath Ltd, a Digital Pathology company acquired by Genetix Plc in 2009 and subsequently part of Leica Biosystems. During his tenure with Leica Biosystems Dr Costello held several roles within the Digital Pathology division including Global Head of Product Management and Director of Life Science Marketing.

  • Career Options
  • Course Fees

    € 650.00

© 2018 Innopharma. All rights reserved.

PrivacyTerms of UseHome