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Pharma compliance guides: GMP, data integrity, ICH and eCTD explained
Short explainers on the compliance terms people in pharma companies search for. Each guide answers the question first, then links to the in-company audio courses that teach the subject in full, with certificate and training record.
- ALCOA plus: data integrity in pharma, explainedALCOA plus explained: the nine data integrity principles, what each letter means, what EU and US inspectors check first, and how to train your staff on them.
- eCTD modules explained: the five-module structureeCTD modules explained: what goes in Modules 1 to 5, how the structure is defined, why EU submissions fail technical validation, and who on your team needs eCTD training.
- EMA training: how the European Medicines Agency worksEMA training explained: what the European Medicines Agency does and does not do, how EMA inspections work, the CTIS training EMA publishes, and how the MHRA fits after Brexit.
- GMP inspection checklist: what EU and FDA inspectors checkA GMP inspection checklist built from what EU and FDA inspectors actually examine: the EU GMP chapters, the FDA systems, the documents to have ready and how findings are graded.
- Good clinical practice certification: what GCP training provesGood clinical practice certification explained: what a GCP certificate is, who issues it, what changed with ICH E6(R3), the EU clinical trials regulation and CTIS, and what a CRO team needs.
- ICH Q9 quality risk management, explainedICH Q9 explained: the two principles, the risk management process, the tools, what the R1 revision of 2023 changed, and how to use it in daily GMP work.
- ICH Q10 pharmaceutical quality system, explainedICH Q10 explained: the four elements of a pharmaceutical quality system, the two enablers, management responsibility, and how a small company builds one inspectors accept.
- Lead auditor certification for GMP: what auditors really needLead auditor certification explained for pharma: what ISO lead auditor courses prove, why GMP auditing is a different job, and the training an internal or supplier auditor actually needs.
- Market access training for pharmaceutical teams: pricing, HTA and tendersMarket access training explained for pharma: how prices and reimbursement are set in Europe, what HTA and the EU HTA regulation change, and how hospital tenders decide who supplies.
- OOS investigation in pharma: phases, flowchart and reportOOS investigation explained: the phase one laboratory check, the phase two full investigation, what the FDA, MHRA and EU GMP expect, and what goes in the report.
- Pharmaceutical sales certification: CNPR and B2B supplier salesPharmaceutical sales certification explained: what the CNPR and similar US rep certificates are for, what EU law asks of medical sales representatives, and the training B2B supplier sales actually needs.
- Regulatory affairs certification: RAC, courses and what employers checkRegulatory affairs certification explained: what the RAC credential is, who awards it, how it differs from a regulatory affairs course, and what a European regulatory role actually needs.
- Training in pharmacovigilance: course fee, certificate and what to learnTraining in pharmacovigilance explained for India and export teams: what a pharmacovigilance course covers, what the fee depends on, what a certificate proves and what EU partners expect.
- What is a qualified person in the pharmaceutical industry?What a qualified person is in the pharmaceutical industry: the EU legal role, QP release and batch certification, Annex 16, the qualifications required and how suppliers work with a QP.
- What is CAPA certification? Meaning and what CAPA training coversCAPA certification explained: what CAPA means in pharma, why there is no official CAPA certificate, what CAPA certified claims usually mean, and what CAPA training should teach.
- What is GMP certification? Meaning, EU certificate and written confirmationGMP certification explained: what GMP certified means, who issues a GMP certificate in the EU, how it differs from a written confirmation, cGMP in the United States, and supplements.