A global healthcare corporation faced significant challenges in complying with 21 CFR Part 11, especially section 11.10 …
Private GMP & Validation Training
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. It isn’t a generic deck about frameworks your team will never apply.
On-site or live virtual Teams of 15+ Built around your environment
Program spec scoped per client
ScopeYour products and your systems
Source materialYour SOPs and validation templates
Calibrated toYour last inspection findings
DeliveredOn-site or live virtualTaught by practitioners, not conference speakers
AcceptanceA team that runs your systems compliantly
Every program is assembled from your environment — nothing off the shelf.
How it works
Three steps, from a scoping call to a trained team.
It’s the same process we use to stand up a validation engagement, applied to your people instead of your systems.
STEP 01
Tell us what you need
We start with a short scoping call to map your products, your team, and your gaps, and to define what “done” looks like: what a competent operator should be able to do when the training ends.
STEP 02
We build it around you
We build a custom curriculum drawn from your SOPs, your processes, and real examples from your own environment. Where useful, we calibrate it against your recent inspection or audit findings.
STEP 03
We deliver it to your team
We deliver it on-site at your facility or live virtual, taught by the same senior consultants who validate these systems in regulated production — and who field the questions that follow.
What we can train on
The disciplines your inspectors check — on the system categories you run.
If your team needs it and it sits inside GxP, we can build it. A representative scope:
Disciplines
GMP fundamentals Process validation CSV & CSA Data integrity 21 CFR Part 11 GAMP 5 EU GMP Annex 11 AI governance in GxP Sterility assurance Analytical method validation
System categories
MES & batch execution LIMS Chromatography data systems (CDS) QMS / eQMS EDMS / document management ERP (GxP) WMS / warehouse RIM EDC / CTMS / eTMF Pharmacovigilance & safety SCADA / PLC automation BMS / EMS monitoring Serialization & track-and-trace Lab instruments Cloud / SaaS systems
// Mapped to your named systems during scoping.
Why it’s different
This isn’t a conference deck with your logo on the cover.
01 — Practitioners, not speakers
Taught by consultants who have validated these systems in regulated production — the people who have written the protocols, not just talked about them.
02 — Your environment, not theory
Built from your SOPs, your workflows, and your own examples. Your team learns on the systems they sign for on Monday, not a vendor’s demo tenant.
03 — Tuned to your findings
Where you share them, recent inspection observations or internal audit findings shape the curriculum — so the training closes the gaps an auditor would actually probe.
Beyond the classroom
When training surfaces a gap, the same team can help close it.
Training maps where your systems and your people are exposed. Because SQA Solution is also a validation consultancy and a specialist staffing partner, you don’t have to take that map to a different vendor. The same experts can stay on to remediate, validate, or place the talent you’re missing — or simply hand you the findings and step back. Your call.
Train → Expose the gaps → Remediate or staff ↺
Who it’s for
Teams that want training mapped to the systems they actually run.
Built for the groups who carry the regulatory weight day to day:
QA Validation Manufacturing Lab & QC Regulatory & Compliance
Start the conversation
Tell us what your team needs to learn.
We bring two decades of life-sciences validation for Fortune 500 pharma and biotech, now focused on one room: yours. Start with a short scoping call, no obligation.
