Short, focused courses that turn regulatory requirements into practical Quality knowledge. Learn the full course for free. Take an optional assessment if you want a verifiable Cuabity course certificate.
PIC/S GMP Part I, Chapter 2 · Personnel — the requirement, its chart, and the scenario.
Practical Quality education without the corporate training price tag.
The difference
Courses identify the source behind important requirements — document, revision and clause — so you are never asked to take a summary on trust. If a course says something is required, you can go and read the sentence that requires it.
“…The heads of Production and Quality Control must be
independent of each other.”
PIC/S PE009-18 Part I, §2.5
Learn how the principles apply to real Quality situations, through worked examples, decision scenarios and the judgement calls that sit between the clause and the shop floor.
Short courses built around one useful subject at a time, with a clear learning path and outcomes you could put to work the next day.
Learn the complete course — every module, scenario and knowledge check — before deciding whether you want an assessment and a certificate at all.
Quality knowledge should not be a luxury. Cuabity makes practical Quality and GMP education freely available, with optional assessment and certification, and a separate pathway for organisations that need tailored training or Quality support.
Courses are organised around practical learning goals, not around software menus. Each public course can be learned in full before any optional certificate purchase.
Understand what GMP asks of you in your own role — and why the rules exist — well enough to work to them from your first shift.
Source basis: PIC/S PE009-18 Part I (24 September 2026), §2.11 basic GMP training.
Work out what ISO 9001 actually requires of a quality management system — as opposed to what people assume it requires.
Source basis: ISO 9001:2026 — Quality management systems — Requirements (sixth edition, September 2026).
Run an out-of-specification investigation the way the FDA guidance sets it out — and know the point at which a result may be set aside, and the far more common point at which it may not.
Source basis: FDA Investigating Out-of-Specification Test Results (Level 2 revision, May 2022), with PIC/S PE009-18 Part I and ICH Q10.
Run a medical-device quality system to ISO 13485 — including the places it deliberately parts company with ISO 9001.
Source basis: ISO 13485:2016 — Medical devices — Quality management systems — Requirements for regulatory purposes.
Apply cosmetic GMP across all seventeen clauses — personnel and premises through to production, control and complaints.
Source basis: ISO 22716:2007 — Cosmetics — Good Manufacturing Practices (GMP).
Apply ALCOA+ to the records, systems and workflows you actually have — and recognise what an inspector is looking for in them.
Source basis: PIC/S PI 041-1 (1 July 2021) and MHRA 'GXP' Data Integrity Guidance (Rev 1, March 2018).
Validate a computerised system in proportion to its risk — from a spreadsheet to a machine-learning model — and know what to write down.
Source basis: EU/PIC/S GMP Annex 11, PIC/S PI 011-3, 21 CFR Part 11 and FDA Computer Software Assurance.
Nine chapters. One structured GMP learning path. Work through the series in order or choose the chapter most relevant to you.
Each course identifies its source basis and revision, carries worked examples, narrated explainers and a decision scenario, and ends with a knowledge check. Written against PIC/S PE009-18 Part I (24 September 2026). Completing the series is not a formal GMP qualification. It is a structured way to learn what the guide asks of you, chapter by chapter.
A single capstone assessment that cuts across all nine chapters — because real situations do not arrive labelled by chapter.
A$59 Assessment & certificate only — the nine courses stay free to learn.All nine chapter assessments plus the comprehensive one, in one payment. Ten individually verifiable certificates.
A$169Quality and GMP requirements can be complicated. Cuabity aims to make them easier to understand without hiding where they come from.
Important requirements are linked to their underlying source — the document, the revision and the clause — so you can read the original rather than take our summary of it.
Concepts are explained through examples, scenarios and workplace decisions, not through restatement of the standard.
Course scope, assessment and certificate limitations are stated plainly. Where a guide is silent or open to interpretation, the course says so instead of resolving it for you.
Work through the complete course at your own pace.
Apply concepts through examples, scenarios and knowledge checks.
Take the formal assessment if you want to test your understanding. It is designed to test your understanding and application of the course material.
Pass the assessment and receive a Cuabity course certificate, with a verification record anyone can check.
The complete course is available to learn for free. If you want to formally test your understanding and document that you passed the course assessment, you can purchase an optional Cuabity course certificate. Learn first. Decide later.
Optional, earned by passing the assessment, and publicly verifiable — by anyone, without an account.
This pays for the assessment and the certificate record. It does not buy the course — the learning is free either way.
The course itself: A$0
What this certificate is not. Cuabity course certificates are certificates of successful completion of a Cuabity assessment. They are not accredited professional qualifications, regulatory approvals or certification to a Quality standard. They do not replace employer-specific training, competency assessment or regulatory requirements. Cuabity is not a certification body and is not affiliated with, accredited by or endorsed by PIC/S, ISO, the TGA or any other regulator or standards organisation.
Cuabity is an independent Australian-based initiative focused on making practical Quality and GMP education more accessible.
Courses are developed around established standards, regulatory guidance and practical Quality experience. Wherever possible, important requirements are identified against their source so learners can examine the basis for what they are being taught.
Cuabity is deliberately independent and focused. The aim is not to reproduce a large corporate training model, but to make useful Quality knowledge easier to access and easier to judge on its substance.
The public catalogue is designed for open, self-paced learning. Organisations that need something more specific can engage Cuabity to develop private training around their processes, products or learning needs.
Custom courses built around your organisation's own procedures, products and processes, delivered privately to your people and not shown in the public catalogue.
Existing subjects adapted to a specific learning need — including practical scenarios and assessments written around the situations your team actually meets.
Where appropriate, defined Quality-related support or consulting engagements. Scope is agreed up front and kept clearly separate from the educational content.
Describe the team, the subject and the environment, and you will get a straight answer on whether Cuabity is the right fit and what it would involve.
Public course learning is free and complete — every module, video, scenario and knowledge check. The optional assessment and the certificate that follows it are paid, from A$29 per course.
Quality, GMP, regulatory and manufacturing professionals, and anyone building practical knowledge in those areas. The courses assume you have a job to do rather than an exam to sit.
Each course identifies its source basis, the revision and date it was written against, and its references, and important regulatory claims are traceable to a clause. Requirements are distinguished from guidance and from our own practical interpretation. Content is drafted with AI assistance and reviewed against the source before publication.
No. They are Cuabity course certificates, awarded for passing the specified assessment. Cuabity is not an accredited certification body and is not affiliated with, accredited by or endorsed by PIC/S, ISO or any regulator. The certificate records that a named person passed a named assessment on a date — and anyone can verify it.
Yes. Private courses built around your own procedures, products and processes can be delivered privately, along with adapted versions of existing subjects and selected Quality support — see Need training for your team?
No. The courses are educational. They do not replace your organisation's own training, qualification, competence assessment or compliance processes, and they are not regulatory advice.
Explore a course, work through it at your own pace, and decide for yourself whether Cuabity is useful.
Start learning — it's free