The Responsible Person for Good Distribution Practice (GDP)
21/22 May 2025, Munich, Germany
Course No. 21746
Speakers
Alfred Hunt
Hunt Pharma Solutions
Dr Daniel Müller
GMP Inspector
Jonathan Riley
Takeda UK
Dr Torsten Schmidt-Bader
moveproTEC Compliance & Innovation Advisory
Objectives
The EU-GDP Guidelines require that wholesale distributors have to appoint a Responsible Person (RP) for GDP. There has been a lot of discussion about the duties of the RP. Therefore, the ECA Foundation’s GDP Working Group has developed this training course. In this course, the role and responsibilities of the Responsible Person for GDP will be highlighted and discussed.
Background
In 2013 the “Guidelines on Good Distribution Practice of Medicinal Products for Human Use” were published. The Guidelines were revised to take into account advancements of practices for an appropriate storage and distribution of medicinal products in the European Union.
In Chapter 2 “Personnel”, tasks and responsibilities of the RP are defined. RPs should fulfil their responsibilities personally and should be continuously contactable. The RP should have appropriate competence and experience as well as knowledge of and training in GDP. He or she may delegate duties but not responsibilities. The RP should carry out their duties in such a way as to ensure that the wholesale distributor can demonstrate GDP compliance and that public service obligations are met.
Target Group
The Training Course is of particular interest to Responsible Persons but also management and quality personnel from pharmaceutical companies, wholesalers, distributors and service providers involved in distribution of medicinal products.
Date & Venue
Date Wednesday, 21 May 2025, 09:00 h – 18:00 h (Registration and coffee 08:30 h – 09:00 h) Thursday, 22 May 2025, 08:30 h – 15:30 h
Venue HYPERION Hotel München Truderinger Str. 13, 81677 München | Germany Phone: +49 89 4110900 E-Mail: Hyperion.Muenchen@h-hotels.com
The counterfeit directive and the introduction of the EU GDP Guidelines
GDP requirements for the pharmaceutical supply Chain
Regulatory expectations for implementation
What is the RP and Wholesaling
Qualification and experience requirements for RP
The Role of RP in management of export & Import
Annex 21: Importation of medicinal products
Export & import to and from EU
Experiences from GMDP Inspections
Inspections of the competent authorities
Typical GDP inspection findings
Controlled Temperature Distribution
How to manage cold chain products
How to manage 15 – 25 °C requirements
Air freight, sea freight, road transport and the last mile
GDP Audits
How to plan the Audit
Approach to GDP Audits
Reporting deficiencies
Examples of recent audit findings
Roles and Responsibilities of the RP
Qualifications requirements for RPs
Responsible Person vs. Qualified Person
GDP vs. GMP
Duties and Delegation
How to discharge your duties
Handling of returned and damaged goods
Complaint Handling
Validation of Computerized Systems under GDP Regulation
Validation requirements – regulatory overview
GAMP oriented validation approach of GDP critical systems
Case Study: Validation of a new Warehouse and Material Management System
Wholesaler in Germany
Workshop: Deviation Management During this workshop participants will learn and discuss how to ensure that the deviation System is being correctly used and implemented.
Security in the Supply Chain
Counterfeit / falsified pharmaceuticals – a real threat!
What is pharma industry doing about it?
Recent developments
How can track & trace support anti-counterfeiting requirements
This course is part of the GMP Certification Programme "ECA Certified GDP Compliance Manager" Learn more
Testimonials
Seminar Programme as PDF