Postgraduate Diploma in In-Line Integration and Process Validation
Online Postgraduate Diploma of 800 hours in In-Line Integration and Process Validation. 8 modules covering ICH Q8(R2), ICH Q9(R1) and SIMCA (Sartorius). Assigned tutor and open enrolment.
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What you will be able to do
Integrate sensors and analysers into automated production lines.
Apply the PAT framework and quality by design to industrial processes.
Plan and carry out FAT, SAT and commissioning tests.
Design three-stage process validation strategies.
Implement univariate and multivariate statistical control in-line.
Use digital twins for virtual commissioning.
Manage compliance documentation and change control.
Who it's for
- Validation engineer looking to specialise in In-Line Integration and Process Validation.
- PAT specialist looking to specialise in In-Line Integration and Process Validation.
- Commissioning engineer looking to specialise in In-Line Integration and Process Validation.
- Process engineer looking to specialise in In-Line Integration and Process Validation.
- Production quality manager looking to specialise in In-Line Integration and Process Validation.
- Automation engineer looking to specialise in In-Line Integration and Process Validation.
- Engineering or science graduates seeking to enter the pharmaceutical sector.
What you'll work with
- ICH Q8(R2)
- ICH Q9(R1)
- ICH Q10
- ICH Q2(R2)
- GAMP 5
- EU GMP Anexo 15
- ISO 7870-2
- ASTM E2500
8 modules · 800 h
1.1Architecture of an automated line1.2Mechanical, electrical and data interfaces1.3Insertion points for sensors and analysers1.4Communication with PLC and SCADA1.5Cycle times and synchronisation1.6Management of rejects and deviations1.7Commissioning engineering requirements1.8Integration documentation1.9Space and installation requirements for in-line equipment1.10Practice: integration diagram for an analyser
2.1FDA's PAT framework2.2In-line NIR, Raman and UV analysers2.3Immersion probes and flow cells2.4Representative in-line sampling2.5Quality by Design (QbD)2.6Critical quality attributes and critical process parameters2.7Design space of the process2.8Real-time release2.9Chemometric models for PAT2.10Laboratory: NIR monitoring of blending
3.1FAT and SAT testing3.2Loop and instrumentation testing3.3Commissioning of control software3.4Interface and communications testing3.5Punch list management3.6Production ramp-up3.7Operator training3.8Handover to production3.9Verification of interlocks and safeties3.10Workshop: FAT protocol for an inspection station
4.1Three-stage validation lifecycle4.2Process design4.3Process performance qualification (PPQ)4.4Continued process verification4.5Validation of analytical methods4.6Statistical sampling and acceptance criteria4.7Validation of computerised systems4.8Revalidation after changes4.9Sampling and strategy for validation batches4.10Practice: validation plan for a filling process
5.1Univariate control charts5.2Multivariate statistical process control5.3Capability indices Cpk and Ppk5.4MSA studies of in-line systems5.5Early detection of deviations5.6Trend analysis5.7Process alarm management5.8Annual product review reports5.9Capability analysis for non-normal processes5.10Laboratory: in-line Hotelling T² chart
6.1Digital twin of the line6.2Discrete event simulation6.3Virtual commissioning6.4Validation of process models6.5Hybrid physical and data-driven models6.6Verification of control logic6.7Testing of abnormal scenarios6.8Maintenance of the twin6.9Validation of simulation models with real data6.10Case study: virtual commissioning of a cell
7.1Good manufacturing practice requirements7.2Requirements traceability matrices7.3Deviation management and CAPA7.4Change control7.5Data integrity in analysers7.6Audits and regulatory inspections7.7Archiving and retention of records7.8Validation performance indicators7.9Periodic review of validation status7.10Case study: preparing for a validation audit
8.1Process description and risks8.2In-line integration design8.3Selection of PAT analysers8.4FAT and SAT test plan8.5Validation strategy8.6Statistical process control8.7Compliance documentation8.8Analysis of results8.9Report and presentation8.10Final review with the tutor
How you'll learn
Training 100 % online on the SEIUM campus, with downloadable material, recorded classes and an assigned technical tutor. No fixed timetable: students progress at their own pace within the intake, which makes it possible to combine with work.
Each module combines theory, guided reading of the original standard and applied exercises. The working software is SIMCA (Sartorius), Siemens SIPAT, Minitab, Siemens Plant Simulation, Siemens TIA Portal, in free, academic or evaluation versions. Trials are studied using real procedures for NIR monitoring of pharmaceutical blending, FAT and SAT testing of inspection stations, and virtual commissioning of automated cells. Assessment is continuous, module by module, plus the final integrating project.
Build it end to end
Your final project follows the real engineering workflow, step by step, reviewed by your tutor.
Integrate sensors and analysers into automated production lines.
Apply the PAT framework and quality by design to industrial processes.
Plan and carry out FAT, SAT and commissioning tests.
Design three-stage process validation strategies.
Implement univariate and multivariate statistical control in-line.
Where this takes you
Requirements
- Prior technical training or professional experience in the sector. A university degree is not required.
- Internet connection and a computer capable of running the programme's software.
- Sufficient level of Spanish to follow the reading of technical regulations.
Ready to start?
Send your application today. Our admissions team replies within 72 hours with your study plan and funding options.
Frequently asked questions
The programme comprises 800 total hours spread over 6 to 8 months. That is between 10 and 15 hours per week on average, compatible with a full-time job.
You work with SIMCA (Sartorius), Siemens SIPAT, Minitab, Siemens Plant Simulation, Siemens TIA Portal. Free, academic or evaluation versions are used, and the tutor indicates the free alternative where one exists.
SEIUM's own diploma upon passing the continuous assessment and the integrating project. It is in-house training, not an official qualification from the Ministry.
Yes. Modules passed in a course or postgraduate diploma in the same area are credited towards the advanced programme. Check the credit transfer policy when you enrol.
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