Certificate in Validation and Instrumentation
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Course Overview
Introduces the learner to the principles of validation and risk management and the application of current Good Manufacturing Practices to the validation of equipment, plant, utilities, processes and procedures in the biopharmaceutical industry.
This programme provides the student with the necessary knowledge and understanding of the manufacturing processes, equipment, tools, control systems and cleanroom technologies needed to function effectively in a highly regulated and controlled pharmaceutical manufacturing environment.
Understanding the Industry
Industry has highlighted through SECBA project engagement that there is a significant need for specialised expertise in many fields such as bioinformatics, analytical chemistry and biotechnology. Quality assurance and control are particularly crucial, with industry seeking competent analysts, Qualified Persons (QPs), and professionals skilled in Quality Management Systems (QMS) and ISO standards.
The growing reliance on technology, including computerised information management, automation and digital skills like bioinformatics and statistical analysis, further underscores the need for graduates with strong tech proficiency. Regulatory compliance, especially in Quality Control, validation, and adherence to standards, is also a priority. However, a noticeable talent gap exists, particularly for roles requiring specialised skills (e.g. Bioprocessing). This highlights the importance of ongoing education and training in related fields to address the skills shortage and ensure a steady pipeline of qualified professionals for the sector.
Career Opportunities
Learners could gain employment within the sector (e.g. Wu-Xi Biologics, Pfizer, Almac, MSD, AbbVie, Grifols, Amryt Pharma etc.) and undertake the programme to obtain a recognised qualification.
Some learners may undertake the programme to ‘re-skill’ and move into the area, they are not employed, or perhaps employed in other Biopharmaceutical areas.
Course Delivery and Modules
This course will be delivered online, with lectures typically take place on Tuesdays and Thursdays in the evening.
Module Learning Outcomes
- Illustrate the need for validation and explain how it complements the regulatory requirements of Good Manufacturing Practice (GMP).
- Explain the instrumentation used to measure/control bioprocesses and interpret P&ID's
- Examine the principles of validation.
- Evaluate how the concepts of preventative techniques can be used to continually improve, such as Quality by Design(QbD).
- Examine suitable validation approaches to achieve process validation over the product lifecycle
- Validation Principles and Regulations
- EU and FDA regulations and guidelines. Quality by design and Risk management, industrially recognised risk management guidelines and tools, such as an introduction to the 7 Quality Improvement Tools i.e. Flowcharts, checksheets, paretos, histograms, cause and effect (C&E) or fishbone diagrams, scatter plots and SPC.
- Instrumentation
- Overview of equipment and instrumentation for process control and Pipe & Instrument Drawings (P&ID) for biopharmaceutical manufacturing. Instrumentation function i.e. Indicators, Sensors, Transmitters and Controllers.
- Process Validation
- Biopharmaceutical process unit operations, Process validation workflow, and process validation prerequisites, Process validation studies: viral clearance, impurity clearance, process consistency, process intermediate stability, process solution stability, drug substance fill/freeze/thaw/storage, mixing studies and chromatography resin and reusable membrane lifetime validation. V-Model. Commissioning and qualification of processes and utilities (water). Process Design, Process Performance Qualification, Continued Process Verification, Cleaning Validation /Verification.
- Prospective, concurrent, retrospective approaches in process validation and revalidation.
- Documentation
- Standard Operating Procedures (SOPs) and Validation documents such as the User Requirement Specification, Validation Master Plan, Validation Protocol and Validation Report etc.
- Teams
- The philosophy and operational principles underpinning the Team approach to Continuous Improvement, such as Kaizen.
Education Progression
Graduates may progress to the Higher Certificate/ Diploma in Science in Biopharmaceutical Manufacturing or similar level 8 programmes. Graduates of the Higher Diploma will be able to progress to level 9 taught postgraduate and Level 9 and 10 research programmes, including Level 9 and 10 research opportunities in DkIT.
Certificate in Science in Biopharmaceutical Manufacturing New course
Higher Diploma in Science in Biopharmaceutical Manufacturing
Fees and Funding
This programme is funded through the South East Cross Border Alliance (SECBA) project, supported by PEACEPLUS, a programme managed by the Special EU Programmes Body (SEUPB).
Fees
Entry requirements
Standard Entry Requirements
- Applicants should have a level 8 major award in Engineering / Science (or equivalent)
or - a Level 7 award in a cognate Science discipline (or equivalent)
or - a Level 7 award in Engineering with a minimum of 2 years’ experience in the Pharmaceutical / Biopharmaceutical Industry (or equivalent)
- Applicants for whom English is not their first language must have English level of IELTS 6.0 or equivalent.
Non-Standard Entry Requirements
Any non-standard entries will be covered by Recognition of Prior Learning.
The part-time programmes are not available to international applicants (the programme includes delivery of practical content on campus, part-time programmes do not fulfil visa requirements).
Recognition of Prior Learning
Applicants who do not meet the standard academic entry requirements but have significant relevant experience (certified and/or experiential) may apply to access this programme via the Recognition of Prior Learning (RPL) route. Learn more about RPL at DkIT
How to apply
Applications will open soon. Register your interest below and we’ll notify you once they open.
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Disclaimer: All module titles are subject to change and for indicative purposes only. All courses are delivered subject to demand and timetables are subject to change. Elective Module options will only run subject to student numbers. The relevant Department will determine the viability of each elective module option proceeding depending on the number of students who choose that option. Students will be offered alternative elective modules on their programme should their preferred elective option not be proceeding. Award Options for Common Entry Programmes: The relevant Department will determine the viability of each award option proceeding depending on the number of students who choose either option. If the numbers for one of the Award options exceed available places, students for this option will be selected based on Academic Merit (highest grades).