Private GMP & validation training
Seeing the same inspection findings come back? Training built on the systems your team actually runs: a private curriculum designed around your SOPs, your processes and your inspection history, taught by the practitioners who validate these systems in production.
The challenges this solves
Generic training doesn’t stick
Off-the-shelf decks cover frameworks your team will never apply to the systems they sign for.
Inspection findings keep repeating
Training isn’t calibrated to the gaps your last inspection or internal audit actually found.
Nobody owns the follow-through
Training exposes gaps, then the remediation goes to a different vendor and starts from scratch.
What we deliver
- Disciplines: GMP fundamentals, process validation, CSV and CSA, data integrity, 21 CFR Part 11, GAMP 5, EU GMP Annex 11
- Specialist topics: AI governance in GxP, sterility assurance, analytical method validation
- System categories: MES and batch execution, LIMS, chromatography data systems (CDS), QMS / eQMS, EDMS
- More systems: GxP ERP, WMS, RIM, EDC / CTMS / eTMF, pharmacovigilance and safety, SCADA / PLC automation
- Monitoring and supply: BMS / EMS monitoring, serialization and track-and-trace, lab instruments, cloud / SaaS systems
- Curriculum mapped to your named systems during scoping and calibrated to recent inspection or audit findings
- For QA, validation, manufacturing, lab and QC, and regulatory and compliance teams
3 steps, clear deliverables
- 01
Tell us what you need
A short scoping call maps your products, team and gaps, and defines what a competent operator should be able to do when training ends.
You receive: Agreed scope and learning outcomes
- 02
We build it around you
A custom curriculum drawn from your SOPs, processes and real examples, calibrated against recent inspection or audit findings where useful.
You receive: Custom curriculum
- 03
We deliver it to your team
On-site at your facility or live virtual, taught by the senior consultants who validate these systems in regulated production.
You receive: A trained team that runs your systems compliantly
Want to know what this would take for your systems? Start with a short scoping call.
Who we do this for
- Pharma & biopharma
- Biotech
- Medical devices
- Cell & gene therapy
- CROs & clinical
Related services
Questions we hear most
Is this an off-the-shelf course?
No. Every program is assembled from your environment: your SOPs, workflows, validation templates and examples, so your team learns on the systems they sign for, not a vendor’s demo tenant.
Who teaches it?
Practitioners, not conference speakers: the same senior consultants who have written and executed validation protocols for these systems in regulated production.
How is it delivered and for how many people?
On-site at your facility or live virtual, for teams of 15 or more.
What happens if training exposes gaps?
Because SQA Solution is also a validation consultancy and a specialist staffing partner, the same experts can stay on to remediate, validate or place the talent you’re missing, or simply hand you the findings. Your call.
Tell us what your team needs to learn
Start with a short scoping call, no obligation.