The Responsible Person for Good Distribution Practice (GDP) - Live Online Training
28/29 April 2027
Course No. 23030
Speakers
Dr Daniel Müller
GMP Inspector
Jonathan Riley
Takeda UK
Dr Torsten Schmidt-Bader
moveproTEC Compliance & Innovation Advisory
Alfred Hunt
Hunt Pharma Solutions
Highlights
- Inspector view: what authorities expect from the RP and the quality system
- RP in practice: self-inspections, validation, deviation management, and export/import
- From cold chain to security: managing different distribution scenarios
Target Group
The 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.
Objectives
The EU GDP Guidelines require wholesale distributors to appoint a Responsible Person (RP) for GDP. According to Chapter 2, 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 his or her duties in such a way as to ensure that the wholesale distributor can demonstrate GDP compliance and that public service obligations are met.
In this Live Online Training, the role and responsibilities of the Responsible Person for GDP will be highlighted and discussed.
Programme
The EU GDP Guidelines
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 and Self-Inspections
How to plan audits and self-inspections
Supplier / vendor audit and self inspection approaches
Reporting deficiencies
Examples of recent 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 and Falsification
Counterfeit / falsified pharmaceuticals – a real threat!
What is pharma industry doing about it?
Recent developments
How can track & trace support anti-counterfeiting requirements
Further Information
Technical Requirements Our live online training courses and webinars are conducted using Webex. At www.gmp-compliance.org/training/online-training-technical-information you will find all necessary information for participation, including a system check to verify whether your IT environment meets the technical requirements. If the installation of browser extensions is restricted due to internal IT policies, please contact your IT department. Webex is widely used, and installation is straightforward.
Presentations/Certificate The presentations for this event will be available for you to download and print before and after the event. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
Fees (per delegate plus VAT) European GDP Association Members EUR 1,890 ECA and European QP Association Members EUR 1,890 APIC Members EUR 1,990 Non- Members EUR 2,090 EU GMP Inspectorates EUR 1,045
The conference fee is payable in advance after receipt of invoice. VAT is reclaimable.
Testimonials
