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GMP — ISO 9001:2015 for Pharmaceuticals Course & Certification
Intermediate
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About
The ISO 9001:2015 for Pharmaceuticals Course & Certification is designed to provide a practical understanding of quality management systems (QMS) and their application in pharmaceutical and life sciences industries. The course focuses on implementing ISO 9001:2015 requirements to ensure consistent product quality, regulatory compliance, and continuous improvement.
This course covers ISO 9001:2015 principles, QMS structure, documentation requirements, process approach, risk-based thinking, internal audits, CAPA, and management review. It also emphasizes quality assurance practices, regulatory alignment, and inspection readiness within pharmaceutical environments. Upon successful completion, learners receive a certification demonstrating competency in ISO 9001:2015 quality management for pharmaceuticals.
Who Should Enrol?
- Quality Assurance and Quality Control Professionals
- Pharmaceutical Manufacturing and Production Teams
- Regulatory Affairs Professionals
- Validation and Compliance Teams
- Clinical Research and Operations Professionals
- Pharmaceutical and Biotechnology Employees
- Life Science, Pharmacy, Chemistry, and Engineering Graduates
What you will learn
Understand the fundamentals of ISO 9001:2015 in the pharmaceutical context, including QMS principles, scope, and relevance to regulated environments.
Learn how ISO 9001 requirements are applied across organizational processes, including leadership, planning, support functions, operations, and risk-based thinking.
Gain knowledge of performance evaluation and continuous improvement systems, including CAPA, internal audits, and quality culture development.
Develop an understanding of audit readiness, certification requirements, and integration of ISO 9001 with GxP systems to ensure consistent quality and compliance.
Course Syllabus
- Introduction to ISO 9001:2015 in Pharmaceuticals
- Concepts (part 1)
- Concepts (part 2)
- A biotech running ISO 9001 + GMP + ICH Q10 as one
- What inspectors look for
- What would you do?
- ISO 9001 vs GMP vs ICH Q10 — where each sits
- Top mistakes + risks
- QMS Fundamentals + Principles
- Concepts (part 1)
- Concepts (part 2)
- PDCA inside a pharma complaint process
- What inspectors look for
- What would you do?
- Process definition template
- Top mistakes + risks
- Context of the Organisation (Clause 4)
- Concepts (part 1)
- Concepts (part 2)
- A CRO defining its context
- What inspectors look for
- What would you do?
- Clause 4 outputs — minimum documented set
- Top mistakes + risks
- Leadership + Quality Culture (Clause 5)
- Concepts (part 1)
- Concepts (part 2)
- A pharma CEO who visibly owns the QMS
- What inspectors look for
- What would you do?
- Quality policy — what makes a good one
- Top mistakes + risks
- Planning + Risk Management (Clause 6)
- Concepts (part 1)
- Concepts (part 2)
- Pharma strategic risk register
- What inspectors look for
- What would you do?
- Risk-register template — columns that matter
- Top mistakes + risks
- Support Functions (Clause 7)
- Concepts (part 1)
- Concepts (part 2)
- Training competence matrix in action
- What inspectors look for
- What would you do?
- Documented information — essential controls
- Top mistakes + risks
- Operations (Clause 8)
- Concepts (part 1)
- Concepts (part 2)
- Supplier management — the Clause 8.4 lens
- What inspectors look for
- What would you do?
- Supplier qualification workflow
- Top mistakes + risks
- Performance Evaluation (Clause 9)
- Concepts (part 1)
- Concepts (part 2)
- A management review that actually decides
- What inspectors look for
- What would you do?
- Management review — mandatory inputs (9.3.2)
- Top mistakes + risks
- Improvement + CAPA (Clause 10)
- Concepts (part 1)
- Concepts (part 2)
- CAPA workflow, end-to-end
- What inspectors look for
- What would you do?
- CAPA workflow — seven stages
- Top mistakes + risks
- Audit Readiness + Certification
- Concepts (part 1)
- Concepts (part 2)
- A clean Stage 2 audit
- What inspectors look for
- What would you do?
- Audit response playbook — from finding to closure
- Top mistakes + risks
- Integration with GxP
- Concepts (part 1)
- Concepts (part 2)
- The integrated pharma QMS pattern
- What inspectors look for
- What would you do?
- ISO 9001 vs GMP — cross-reference (sample)
- Top mistakes + risks
- Course Complete
Course Benefits
CPD Points
Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
Certification
Receive a personal certificate to show your subject knowledge on course completion.
Affordable
You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
Flexibility
The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
Keep Up to Date
You will stay up to date with any changes to ISO 9001:2015, EU GMP Part I, ICH Q9 (Quality Risk Management), ICH Q10 (Pharmaceutical Quality System), and 21 CFR Part 210/211 as our training courses are constantly monitored, reviewed and updated.
Learn from Industry Experts
The course content has been developed by certified ISO 9001 lead auditors and pharmaceutical QA practitioners to ensure that learners can apply Annex SL clauses to a regulated GMP environment. Every lesson follows the same pedagogical rhythm — concept cards, a real pharma case study, an audit-flag warning, an SOP-side checklist, a standards map, a do/do-not rulebook, and a scenario knowledge check.
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