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Technical GMP for Engineering, Validation and Qualification

Updated Friday, 28 August 2026 at 08:18

A two-day in-house program for engineering and validation staff on the GMP consequences of technical work, built around an intervention that goes wrong.

One trainer, one team, your premises

Run for your team at your location. We adapt the material to your products, SOPs and recent inspection findings, taught by the same trainers who run our public PCS Academy courses.

Request a custom training quotation

What's included

Programme adapted to your products and SOPs
Trainer travels to your premises: no staff time lost
Dates that fit your production schedule
Individual certificate for every participant
Same trainers who teach our public PCS Academy courses

Difficulty

Intermediate level

Topics

Change Control GMP Deviations Calibration Validation Qualification CSV CCS Data Integrity CAPA Impact Assessment Rootcause Analysis Water Systems Risk Management Training Facility Equipment Documentation Annex 11 Computerized Systems GDocP Utilities Steam Systems Filtration Premises Air Handling Isolator RABS WFI

Also available as in-house

What you will learn

Place user requirements, DQ, IQ, OQ and PQ in the qualification framework and explain what "qualified" does and does not guarantee

Assess maintenance and interventions in classified areas as a contamination risk, including temporary repairs and their expiry date

Explain the GMP impact of HVAC, purified water, compressed gases and clean steam, and what an alarm means for the patient

Identify the part of the Contamination Control Strategy that engineering owns, including HEPA integrity testing, pressure cascades and filters

Apply Annex 11 requirements to PLC, SCADA and BMS access control, audit trails, backup and periodic review, and to technical spreadsheets

Distinguish failure mode from root cause and judge whether a technical CAPA actually holds

Document maintenance activity, as-built drawings and material traceability so that technical work holds up under GMP scrutiny

Perform an impact assessment on an intervention that goes wrong and take the resulting decisions

Description

Engineering occupies a particular position in GMP: the work is technical, the results have an impact on the patient.

A temporary repair that nobody assigned an expiry date to, a HEPA filter signed off without integrity testing, a BMS with three people sharing one login, a technical CAPA that fixes the effect but not the cause, each of these a routine engineering decision with a patient at the end of it. This two-day in-house program is about that tension.

Day 1, GMP foundation. A shared day that establishes what GMP asks, how a quality system works, what a signature commits you to, and why SOPs alone do not produce quality culture.

Day 2, technical GMP. The qualification framework and what "qualified" does and does not guarantee. Maintenance as a contamination risk. Utilities and what an alarm actually means for the patient. The part of the Contamination Control Strategy that engineering owns. Annex 11 applied to PLC, SCADA and BMS, and to the spreadsheets used for technical calculations, which is where most sites are weakest. Technical documentation, traceability, and formal handover of equipment back to production.

The day closes with a practical workshop/scenario. The group performs the impact assessment and takes the decisions.

Maximum 20 to 25 participants per session
Covers Annex 15 and its upcoming revision, Annex 1, Annex 11 and the updated PI 006-4
All workshop and case material supplied by PCS
Certificate of attendance for every participant

Target Audience

Engineering, maintenance, validation and qualification staff, including technicians working in classified areas and the engineers who plan and approve their work.

Day 1 is the shared GMP foundation, so no prior GMP knowledge is assumed. Day 2 works at the level of someone who has to judge technical decisions against GMP requirements.

Day 1, GMP foundation: quality and quality systems; documentation and data integrity; GMP behaviour; deviations, change control, CAPAs and risk management; records and evidence; quality culture; own responsibility in GMP; workshop.

Day 2, technical GMP: qualification and validation (URS, DQ, IQ, OQ, PQ, Annex 15, PI 006-4); maintenance under GMP; utilities and their GMP impact; introduction to Annex 1 and the Contamination Control Strategy; computerised systems and Annex 11; technical documentation and traceability; technical deviations, root cause and handover; intervention workshop.