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Postgraduate DiplomaRobotics, Automation & Control Applications open

Diploma in Qualification/Validation and PQ

Online postgraduate diploma of 800 hours in qualification/validation and PQ: 8 modules covering qualification fundamentals, IQ, OQ, PQ, process validation, statistical tools and maintenance of the qualified state under EudraLex Volume 4 Annex 15, the FDA Process Validation Guidance 2011 and ASTM E2500-20, with an assigned technical tutor.

Duration6–8 months
ModeOnline
LanguageEnglish
Start datesSet by the faculty
AwardSEIUM Institute diploma
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Learning outcomes

What you will be able to do

01

Plan equipment qualification according to Annex 15 and ASTM E2500.

02

Write IQ protocols with verifiable acceptance criteria.

03

Design and run OQ tests of functions and limits.

04

Plan a representative PQ with statistical criteria.

05

Apply the three-stage approach to process validation.

06

Analyse qualification data using statistical tools.

07

Maintain the qualified state through change control and requalification.

Profile

Who it's for

  • Qualification and validation technicians.
  • Process validation engineers.
  • Validation managers.
  • Thermal mapping specialists.
  • Pharmaceutical commissioning engineers.
  • GMP quality auditors.
  • Engineering or science graduates seeking to move into the pharmaceutical industry.
Standards & tools

What you'll work with

  • EudraLex Volume 4 Annex 15 (qualification and validation)
  • FDA Process Validation Guidance 2011 (lifecycle approach to process validation)
  • ASTM E2500-20 (science- and risk-based verification of manufacturing systems)
  • ICH Q8(R2) (pharmaceutical development)
  • ICH Q9(R1) (quality risk management)
  • EudraLex Volume 4 Annex 1 (manufacture of sterile medicinal products)
  • ISPE Baseline Guide Commissioning and Qualification (C&Q practice)
  • WHO TRS 1019 Annex 3 (validation guidelines)
  • Kneat Gx
  • ValGenesis VLMS
  • Minitab
  • JMP
  • Ellab ValSuite
Syllabus

8 modules

  1. 1.1Difference between qualification and validation
  2. 1.2The Annex 15 lifecycle approach
  3. 1.3User requirements as the starting point
  4. 1.4Design qualification (DQ)
  5. 1.5Verification according to ASTM E2500
  6. 1.6Factory and site acceptance testing
  7. 1.7Leveraging FAT and SAT
  8. 1.8Roles of quality, engineering and users
  9. 1.9Qualification documentation
  10. 1.10Case study: qualification strategy for a filling machine
  1. 2.1Objectives of IQ
  2. 2.2Verification of drawings and documentation
  3. 2.3Checking materials and certificates
  4. 2.4Instrumentation and calibrations
  5. 2.5Verification of software and versions
  6. 2.6Connected utilities
  7. 2.7Deviations during IQ
  8. 2.8Installation acceptance criteria
  9. 2.9IQ report
  10. 2.10Practical exercise: IQ protocol for an autoclave
  1. 3.1Objectives of OQ
  2. 3.2Function and alarm testing
  3. 3.3Operating limit testing
  4. 3.4Interlock and safety testing
  5. 3.5Control system testing
  6. 3.6Thermal mapping of equipment
  7. 3.7Power failure recovery testing
  8. 3.8OQ deviation management
  9. 3.9OQ report
  10. 3.10Workshop: OQ testing of a freeze dryer
  1. 4.1Objectives and scope of PQ
  2. 4.2Use of product or placebo
  3. 4.3Design of PQ batches
  4. 4.4Worst cases and extreme conditions
  5. 4.5Sampling and statistical plans
  6. 4.6Statistical acceptance criteria
  7. 4.7Process capability in PQ
  8. 4.8Sterility assurance in PQ
  9. 4.9PQ report and approval
  10. 4.10Practical exercise: PQ sampling plan for a tablet line
  1. 5.1The 2011 FDA process validation guidance
  2. 5.2Stage 1: process design
  3. 5.3Stage 2: process performance qualification
  4. 5.4Stage 3: continued process verification
  5. 5.5Number of validation batches
  6. 5.6Concurrent and retrospective validation
  7. 5.7Aseptic process validation with media fill
  8. 5.8Transport validation
  9. 5.9Revalidation and changes
  10. 5.10Case study: PPQ protocol for a granulation process
  1. 6.1Design of experiments for the process
  2. 6.2Tolerance intervals
  3. 6.3Cpk and Ppk capability
  4. 6.4Control charts for continued verification
  5. 6.5Analysis of variance between batches
  6. 6.6Justified sample size
  7. 6.7Equivalence testing
  8. 6.8Statistical software
  9. 6.9Interpretation for inspectors
  10. 6.10Laboratory: capability analysis of PQ data
  1. 7.1Calibration and preventive maintenance
  2. 7.2Periodic requalification
  3. 7.3Change control and impact assessment
  4. 7.4Annual product review
  5. 7.5Trending of critical parameters
  6. 7.6Management of recurring deviations
  7. 7.7Paperless qualification
  8. 7.8Qualification audits
  9. 7.9Lessons learned
  10. 7.10Practical exercise: risk-based requalification plan
  1. 8.1Selection of the equipment and process
  2. 8.2User requirements
  3. 8.3DQ, IQ and OQ strategy
  4. 8.4PQ design
  5. 8.5Statistical sampling plan
  6. 8.6Process validation protocol
  7. 8.7Continued verification plan
  8. 8.8Evaluation of results
  9. 8.9Report and presentation
  10. 8.10Final project: final review with the tutor
Methodology, software & labs

How you'll learn

Training is 100% online on the SEIUM campus, with downloadable material, recorded classes and an assigned technical tutor. There are no fixed timetables: you progress at your own pace within each intake, making it compatible with work.

Each module combines theory, guided reading of the original standard and applied exercises. The working software is Kneat Gx, ValGenesis VLMS, Minitab, JMP and Ellab ValSuite, in free, academic or evaluation versions. Tests are studied on real procedures: an IQ/OQ qualification protocol for a piece of equipment, statistical design of a PQ, and thermal mapping of an autoclave. Assessment is continuous by module plus the final project.

Standards covered: EudraLex Volume 4 Annex 15, FDA Process Validation Guidance 2011, ASTM E2500-20, ICH Q8(R2), ICH Q9(R1), EudraLex Volume 4 Annex 1, ISPE Baseline Guide Commissioning and Qualification, WHO TRS 1019 Annex 3.

Assigned technical tutor:every module ends with a deliverable that your tutor marks individually.
Standards-based learning:guided reading of EudraLex Annex 15, the FDA Process Validation Guidance and ASTM E2500 applied to real cases, not as a theoretical annex.
Industry software:Kneat Gx, ValGenesis VLMS, Minitab, JMP and Ellab ValSuite, in free, academic or evaluation versions.
Final project:a complete qualification and PQ package for a piece of equipment and process, with a statistical sampling plan and continued verification plan, reviewed by your tutor.
Flexible format:100% online, no fixed timetables, compatible with full-time work.
Capstone project

Build it end to end

Your final project follows the real engineering workflow, step by step, reviewed by your tutor.

User requirements
Select the equipment and process and define the user requirements.
DQ, IQ and OQ strategy
Plan the design, installation and operational qualification strategy.
PQ design
Design the PQ with a statistical sampling plan and acceptance criteria.
Process validation protocol
Write the process validation protocol and the continued verification plan.
Final project
Evaluate the results and present the report to your tutor.
Career opportunities

Where this takes you

Qualification and validation technicianProcess validation engineerValidation managerThermal mapping specialistPharmaceutical commissioning engineerGMP quality auditor
Admissions & scholarships

Requirements

  • Prior technical training or professional experience in the sector. No university degree is required.
  • Internet connection and a computer capable of running the programme software.
  • English sufficient to read technical standards.

Ready to start?

Send your application today. Our admissions team replies within 72 hours with your study plan and funding options.

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FAQ

Frequently asked questions

The programme totals 800 hours over 6–8 months. You set your own pace within each intake, and your tutor helps you plan the workload around your job.

You work with Kneat Gx, ValGenesis VLMS, Minitab, JMP and Ellab ValSuite, using free, academic or evaluation versions. Your tutor indicates the free alternative wherever one exists.

A SEIUM Institute diploma, awarded on passing the continuous assessment and the final project. It is SEIUM's own qualification, not an official state degree; its recognition depends on the programme completed and the regulations of each country.

Yes. Modules passed are recognised in a higher programme in the same area (postgraduate diploma or master's). Ask about the recognition policy when you enrol.

Prior technical training or professional experience in the sector (no university degree required), a computer capable of running the software, and English sufficient to read technical standards.

Start dates are set by SEIUM's faculty for each intake. Our admissions team will confirm the next available date when you apply.

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