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Pharmaceutical Quality Assurance & GMP Complete Course
Published 9/2026
MP4 | Video: h264, 1920x1080 | Audio: AAC, 44.1 KHz, 2 Ch
Language: English | Duration: 14h 44m | Size: 4.95 GB
Learn the quality system behind every medicine: GMP, SOPs, records, deviations, change control, validation, audits
What you'll learn
Define quality, quality assurance and a quality system for a regulated medicinal product, and say who has to be satisfied by each
Explain what GMP requires of a manufacturer, and why failing to follow it puts a drug outside the law in any market
Write and control a standard operating procedure: structure, standards of performance, authorization and revision
Apply good documentation practice - make a correction properly, handle an expected blank, and deal with a late entry correctly
Spot a non-conformance, report it correctly, investigate it, and tell a recall from a withdrawal
Take a change through a change control system and classify it against a regulator's change levels
Plan a validation project and distinguish DQ, IQ, OQ and PQ, and say what evidence each one produces
Prepare for a regulatory inspection, grade the observations, and predict whether they give a compliant rating
Plan and run a quality audit through its five stages, and write a finding as a fact rather than an opinion
Design, deliver and evaluate GMP training, and prove that it actually worked
Requirements
No prior quality assurance experience is needed.
A background in pharmacy, science, engineering or a life science helps you move faster, but is not required.
Some exercises are easier with a real procedure, batch record or audit report to hand - each one also has an alternative that uses an everyday document.
Description
Quality assurance in a pharmaceutical plant is not a department. It is a system - and this course teaches the whole of it.
A patient cannot inspect a tablet. They cannot see that it is sub-potent, or contaminated, or that the batch before it failed. That single fact is why this industry is regulated the way it is, and it is where this course starts.
Twelve lectures. Around fourteen hours. By the end you will understand how a pharmaceutical quality system actually fits together - not as a list of definitions to memorise, but as a chain you can trace from a written procedure, through the record that proves it was followed, to the inspector who asks to see it three years later.
What the course covers
- Introduction to Quality - what quality means for a regulated medicinal product, the five pillars used to assure it, and why compliance and quality are not the same thing
- Quality Systems and Quality Assurance - what a quality system contains, who is accountable for each part of it, the standards that apply, and what quality costs
- Introduction to GMP - how the international, US and Canadian texts word it, what GMP requires of a manufacturer, and how to find a requirement by its section number
- Standard Operating Procedures - deciding when a task needs one, who should write it, how to structure it, and how to write a step to a standard of performance
- Documentation - what counts as proof, the recurring failures inspectors find, and exactly how to make a correction, handle a blank and deal with a late entry
- Non-Conformances, Complaints and Recalls - recognising and reporting a deviation, how QA investigates it, and the difference between a recall and a withdrawal
- Change Control - the seven-step process, who approves at each gate, and how to classify a change against a regulator's change levels
- Validation: An Introduction - the 4 C's and the 4 D's, DQ, IQ, OQ and PQ, and choosing between prospective, concurrent and retrospective validation
- Regulatory Inspections - the types of inspection, preparing people and records, what an inspector may lawfully do, and how to answer
- GMP Risk Classification and Inspection Readiness - grading observations as critical, major or other, predicting a compliant or non-compliant rating, and building a readiness plan
- Quality Audits - first, second and third party, choosing an approach, the five stages from preparation to closure, and writing findings as facts
- Training - the requirement in three jurisdictions, how adults actually learn, designing a course, and proving the training worked
How it is taught
Every lecture is built the same way: learning objectives at the start, the material in numbered stages, a knowledge check at the end of each stage, and the objectives ticked off at the close so you can tell what landed and what did not.
One company runs through the entire course. ClearMed is a fictional manufacturer, and you meet it in the first lecture and leave it in the last. Its batch fails, its complaint arrives, its coder is replaced, its change is classified, its inspection is graded, its audit is written up. Concepts you meet in the abstract come back as something that happened to a company you have been following for fourteen hours.
There are worked examples, knowledge checks and applied exercises throughout - and the exercises are designed so that you can do them without being inside a pharmaceutical plant.
A note on sources
Every regulatory statement in this course is cited to a named instrument and its current edition, and where a definition comes from a withdrawn or superseded document the course says so on the slide rather than teaching it as current. The material draws on WHO, ICH, PIC/S, EU GMP, US FDA and ISO texts, with one jurisdiction used as a worked example wherever the detail is jurisdiction-specific.
Where something could not be verified against a primary source, it is flagged rather than guessed.
Who this is for
If you are moving into quality assurance or regulatory affairs, already work under GMP and want to understand the system around you, or are preparing for your first inspection or internal audit - this is the whole framework in one place.
Who this course is for
Pharmacy, science and engineering graduates aiming for a first role in quality assurance or regulatory affairs
Production, quality control, engineering and warehouse staff who work under GMP and want to understand the system around them
New QA associates and regulatory affairs professionals who need the whole framework, not one topic at a time
Anyone preparing for a regulatory inspection or an internal audit for the first time
Medical device and other regulated-industry professionals who want the pharmaceutical quality assurance model in full
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