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Pharmaceutical and Veterinary Medicinal Products (EU 2021/1248) Course & Certification
Intermediate
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About
Pharmaceutical and Veterinary Medicinal Products (EU 2021/1248) is a comprehensive program designed to provide professionals with a practical understanding of Good Distribution Practice (GDP) requirements for the storage, transportation, and distribution of human and veterinary medicinal products. The course focuses on maintaining product quality, integrity, traceability, and regulatory compliance throughout the pharmaceutical supply chain.
This Pharmaceutical and Veterinary Medicinal Products (EU 2021/1248) Course & Certification provides structured training on GDP regulations, quality management systems, personnel responsibilities, storage and transportation controls, documentation practices, deviation management, CAPA, recalls, audit readiness, and operational excellence. Upon completion, learners receive certification demonstrating competency in GDP principles and distribution compliance for pharmaceutical and veterinary medicinal products.
Who Should Enrol?
- Pharmaceutical and Veterinary Medicinal Product Distribution Professionals.
- Quality Assurance, Quality Management, and Regulatory Affairs Personnel involved in GDP compliance.
- Warehouse, Logistics, Supply Chain, and Transportation Professionals handling medicinal products.
- Responsible Persons (RPs), GDP Compliance Officers, and Audit & Inspection Readiness Teams.
- Entry-level professionals and consultants seeking certification in pharmaceutical and veterinary medicinal product distribution and GDP compliance.
What you will learn
Understand GDP requirements, regulatory expectations, and the quality management systems needed to ensure compliant distribution of medicinal products.
Learn best practices for personnel training, premises and equipment management, storage conditions, inventory control, and transportation activities.
Develop expertise in documentation, record keeping, deviation management, CAPA implementation, and risk-based decision-making within GDP operations.
Gain knowledge of complaint handling, product returns, recalls, audit preparation, inspection readiness, and operational excellence across the supply chain.
Course Syllabus
- What is GDP
- Why GDP matters
- Scope of GDP
- Veterinary medicinal products
- Stakeholders in the GDP chain
- Core GDP principles
- EU GDP guidelines for human medicinal products
- Veterinary regulation
- Falsified Medicines Directive
- Regulatory authorities
- Wholesale Distribution Authorisation
- Inspection regimes
- Enforcement actions
- QMS foundations
- Document and record management
- Quality risk management
- Change control
- Management review
- Continuous improvement
- The Responsible Person
- Operational roles
- Training programme
- Competency assessment
- Quality culture
- Warehouse layout
- Storage zones
- Temperature monitoring
- Equipment qualification
- Calibration and maintenance
- Computerised systems validation
- Cleaning, pest control, hygiene
- Receipt of goods
- Storage conditions
- Inventory management
- Expiry management
- Picking and dispatch
- Returns and disposition
- Special handling
- Transport principles
- Cold-chain transportation
- Transport validation
- Drivers and contractors
- Cross-border distribution
- Excursion handling
- GDP documentation requirements
- ALCOA+ in practice
- Document control
- Records
- Electronic records
- Batch traceability
- Deviations
- Root cause analysis
- Corrective and Preventive Action
- Risk management
- Trending and pattern analysis
- Quality culture and deviation management
- Complaint handling
- Returns management
- Falsified medicines
- Product recalls
- Risk mitigation
- Audit and inspection types
- Preparing for inspection
- During the inspection
- Common findings
- Responding to findings
- Inspection-ready every day
- From compliance to excellence
- Managing supply chain risks
- Preventing product loss and damage
- Continuous improvement
- Quality metrics that drive behaviour
- Supplier and customer partnerships
- Sustainability and ESG
- Building durable capability
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 EU Commission Implementing Regulation 2021/1248, human GDP guidelines (2013/C 343/01), Falsified Medicines Directive and national competent authority enforcement practice, as our training courses are constantly monitored, reviewed and updated.
Learn from Industry Experts
The course content has been developed by GDP responsible persons and veterinary supply-chain experts to ensure learners can apply EU 2021/1248 in practice.
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