One-day or half-day Good Distribution Practice (GDP) training which covers the directives, regulations and guidelines of GDP as per EU and HPRA/MHRA requirements.
The course is highly interactive aimed at individuals who wish to increase their knowledge and understanding of the actual requirements of GDP and better understand the complex supply chain through which products flow.
Recommended for companies in the following sectors:
Active ingredient and excipient manufacturers & distributors
Medical device manufacturers & distributors
Wholesalers/Distributors including grocery wholesalers
Wholesale Distribution Authorisation (Licence) holders or those considering applying for a WDA licence
Understand the regulatory requirements and constraints facing manufacturers, distributors/wholesalers and transport/logistics companies in the management of the full supply chain from sourcing to final distribution.
Become familiar with the EU, HPRA and MHRA legal requirements for GDP.
Increase awareness of the expectations of regulators.
Identify the controls necessary to ensure compliance along the GDP supply chain.
Discuss current EU Guidelines 2013/C 343/01, the impact of the new Falsified Medicines Directive and increasing standards required in a compliant supply chain.
Who should attend:
Responsible Person/Deputy RP
Regulatory and Compliance staff
According to the EU GDP Guidelines 2013/C 343/01
"Personnel should receive initial and continuing training relevant to their role, based on written procedures and in accordance with a written training programme."
Evaluate Good Distribution Practice Directives (92/25/EEC, 2001/83/EU, 2004/27/EC), the EU Guidelines on Good Distribution Practice 2013/C 343/01 and HPRA/MHRA Guidelines and legal requirements under which Wholesale Authorisation holders must manage their licence.
Discuss the new Falsified Medicines Directive.
Practical explanation of the guidelines for those who are implementing GDP.
Explanation of the management of quality systems and the supply chain from sourcing to final delivery.
Discussion of up-to-date deficiencies found by regulators.
A Certificate of attendance including relevant CPD hours will be issued to all who successfully complete the course and once full payment is received.
"Found all aspects of the course extremely valuable and gave an excellent introduction to GDP and regulatory expectations. Excellent real-life examples were given."
For further information, or to book a place, please contact us