This Good Distribution Practice (GDP) training course is for the designated Responsible Person (RP), the deputy responsible person (DRP) and those responsible for quality, compliance and security
It provides an understanding of GDP in relation to the Health Products Regulatory Authority (HPRA) guidelines, for the Pharmaceutical Supply Chain.
The European Union (EU) Falsified Medicines Directive amends Directive 2001/83/EC which safeguards public health by protecting the pharmaceutical supply chain from infiltration by falsified (or counterfeit) medicines and introduces new rules to more rigorously regulate the supply chain.
GDP is a critical element of the overall Quality Assurance System (QAS) and its’ role in the supply chain is the Pharmaceutical industry in particular, is significant.
2 full days, classroom based.
Maximum 5-6 persons
Onsite within your business
Learning outcomes and content
Good Distribution Practice, within the Pharmaceutical supply chain, is key for organisations looking to acquire or maintain a Wholesale Distribution Authorisation (WDA). There is a significant impact on the manufacture of pharmaceutical products from the legislative and regulatory GDP guidance and this course provides insights and opportunity to discuss GDP and its’ relevant for your business.
This training course covers the complexities of the supply chain and the critical role of the responsible persons.
What will you learn on this course?
- Understanding the requirements of GDP
- Required roles for GDP in the pharmaceutical supply chain
- Understanding the related EU directive
- The role of the HPRA
- The Falsified Medicines Directive (FMD) and the importance of checks on suppliers, transportation partners and customers
- The rise of counterfeit and illegal product entering the pharmaceutical supply chain
- Patient safety
This 2 day course comprises of classroom training and workshop exercises (covered in day 2).
What is in the relevant EU directive and HPRA guidelines?
The EU directive 2013/C 343/01 and HPRA guidelines contain very specific requirements for roles appointed within the pharmaceutical supply chain.
Our training course peels back those requirements and walks through the specific requirements with the attendees to ensure there is an understanding from a regulatory and practical application within their supply chain, covering;
- What is Good Distribution Practice (GDP)?
- GDP in the supply chain
- How critical GDP is in the supply chain
- The pharmaceutical supply chain
- The pharmaceutical quality chain
- Required roles within GDP
- The role of the Health Products Regulatory Authority (HPRA)
- The course also looks at the implications of BREXIT on the pharmaceutical supply chain
Who should attend this GDP training course?
Since this course covers good distribution practice, and is required for companies acquiring or maintaining a Wholesale Distribution Authorisation (WDA), there is a small group of personnel who will be required to attend formal training, with general operatives and other resources subsequently trained by the responsible person.
- The designated Responsible Person (RP)
- The deputy Responsible Person (DRP)
- Those responsible for quality and compliance and security