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GMP for Pharmaceutical Packaging and ISO 15378 Course & Certification
Intermediate
4.7
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97% Recommended
3 hours
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2 points
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About
GMP for Pharmaceutical Packaging and ISO 15378 training provides essential knowledge on Good Manufacturing Practice requirements specific to pharmaceutical packaging materials and the ISO 15378 standard for primary packaging. It focuses on ensuring product quality, safety, and regulatory compliance throughout packaging operations.
This course covers GMP principles, contamination prevention, documentation and traceability, supplier quality management, risk management, and ISO 15378 quality system requirements. It also highlights audit readiness, compliance obligations, and best practices for maintaining packaging integrity in the pharmaceutical industry.
Who Should Enrol?
- Packaging and Production Operators
- Quality Assurance and Quality Control Personnel
- Regulatory Affairs Professionals
- Supply Chain and Procurement Teams
- Manufacturing Supervisors and Managers
- Compliance and Audit Professionals
- Anyone involved in pharmaceutical packaging operations and quality systems
What you will learn
Understand the principles of GMP for pharmaceutical packaging and ISO 15378 requirements, including their role in ensuring product quality and patient safety.
Learn key requirements for packaging operations, including contamination control, cleanliness standards, and environmental controls in regulated manufacturing areas.
Develop knowledge of documentation practices, traceability, supplier qualification, risk management, and change control specific to pharmaceutical packaging materials.
Gain understanding of ISO 15378 quality management system requirements, compliance expectations, audits, and best practices for maintaining packaging integrity and regulatory compliance.
Course Syllabus
- Five material families: glass, rubber, aluminium, plastic, composites
- Pharmacopoeial glass classes and elastomer types
- Selecting the right component
- Extractables and leachables
- ISO 15378 = ISO 9001 + pharma GMP
- FDA 21 CFR 211 and container-closure guidance
- EU GMP Annexes and pharmacopoeial chapters
- ICH Q9 risk-based thinking
- Why artwork errors drive recalls
- The design-and-artwork lifecycle and mandatory content
- Cross-functional approval, version and change control
- Proofing and multi-region artwork
- Line clearance and line flow
- In-process controls and reconciliation
- Serialisation and aggregation
- End-to-end traceability and environmental controls
- Identity, performance and stability
- Compendial tests for glass, rubber and plastic
- CCIT, barrier and performance testing
- Extractables, leachables and statistical sampling
- Risk-tiering packaging suppliers
- Qualification and the Quality Agreement
- Scorecards and change control
- Incoming inspection, complaints and recalls
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 ISO 15378 and ISO 9001:2015, FDA 21 CFR 210/211 and container-closure guidance, EU GMP (Annex 1, 8, 15, 16), WHO GMP technical reports, the USP, Ph. Eur. and JP packaging chapters, and serialisation requirements under the EU FMD and US DSCSA.
Learn from Industry Experts
The course is written and reviewed by Regulatory Affairs and packaging-quality experts who have selected, qualified and defended primary packaging systems across pharmaceutical and medical-device organisations.
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