Truex Consultancy · Professional GMP Training
GMP Training Courses
Specialist, exam-assessed online training aligned with EudraLex Volume 4 and ICH guidelines. Built for QA professionals, manufacturers and contract sites that need training evidence that stands up in an inspection.
Foundations
GMP Foundations
Introduction to GMP
What GMP is, why it exists, and how the rules protect patients. The complete grounding for anyone entering a regulated environment.
Quality Systems
Mastering Daily PQS Management
Run the pharmaceutical quality system as a daily operating rhythm, not a binder on a shelf. Built on ICH Q10.
Quality Systems & Operations
EudraLex Ch. 4
GMP Documentation & SOP Writing
Write SOPs people can actually follow and records that hold up under scrutiny. If it is not documented, it did not happen.
Annex 15 · Ch. 1
Change Control in GMP
Assess, approve and document change before it breaks a validated process.
Quality Operations
Deviation Management
Record, contain and investigate the unexpected, and prove product impact with evidence.
ICH Q10
CAPA in GMP Environments
Corrective and preventive action that actually prevents recurrence, with verified effectiveness.
ICH Q9
Root Cause Analysis in GMP
Structured investigation tools that find the real cause instead of writing “human error”.
Annex 11 · ALCOA+
Data Integrity in GMP
Trustworthy records and audit trails, and the falsification patterns that end companies in major markets.
EudraLex Ch. 8
Complaints Management
Treat every market complaint as quality data and catch safety signals early.
EudraLex Ch. 8
Product Recall & FSCA
Mobilise, reconcile and retrieve fast when defective product reaches the market.
ICH Q10
Management Review in GMP
Make leadership review a working control of the quality system, with decisions, owners and follow-up.
EudraLex Ch. 5 & 7
Supplier Qualification & Vendor Management
Qualify suppliers with evidence, govern them with quality agreements, monitor them with data.
Audit & Inspection Readiness
Health Authority Inspections
GMP Inspection Readiness
Be ready for the inspection that decides your licence: hosting, conduct, document flow and recovery.
EudraLex Ch. 9
Self-Inspection & Internal Audit
Find and fix your own gaps before a regulator does, with an audit programme that is real.
For CMOs
Client Audit Readiness – CMO Prep
Pass client audits as a contract site: readiness files, mock audits, QTA compliance and recovery from findings.
EudraLex Ch. 7
Contract Manufacturer Audit Preparation
Audit your CMO properly: the oversight regulators expect the contract giver to prove.
Training your whole team?
Team seats with a group dashboard, exportable completion records and certificates ready for your training file. Volume pricing from 10 seats, site licences available.