The Responsible Person for Good Distribution Practice (GDP)

The Responsible Person for Good Distribution Practice (GDP)

Vienna, Austria

Kurs Nr. 20279

This course is part of the GMP Certification Programme "ECA Certified GDP Compliance Manager". Learn more.


Kosten

ECA-Member*: EUR 1590,--
Non ECA Member*: EUR 1790,--
EU/GMP Inspectorates*: EUR 895,--
APIC Member Discount*: EUR 1690,--
GDP Association Member Discount*: EUR 1590,--
QP Member Discount*: EUR 1590,--

Alle Preise zzgl. MwSt.

* auch unkompliziert per Kreditkarte bezahlbar American Express Visa Mastercard

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Speakers

Prabjeet Dulai, GDP & Quality Matters
Dr Martin Egger, Pharmaserv
Alfred Hunt, Hunt Pharma Solutions
Dr Daniel Müller, GMP/GDP Inspector
Dr Laura Ribeiro, OCP Portugal

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.

Roadmap to Good Distribution Practice

All participants receive a Roadmap to Good Distribution Practice containing:
  • An overview of the designated Responsibilities for Senior Management, Responsible Person and Authority
  • Checklist for the implementation of GDP principles

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
Roles and Responsibilities of the Responsible Person
  • Qualifications requirements for RPs
  • Duties and Delegation
  • How to discharge your duties
Experiences from GMDP Inspections
  • Inspections of the competent authorities
  • Typical GDP inspection findings
Management of Export and Import
  • Annex 21: Importation of medicinal products
  • What does batch release mean?
  • Export and import to and from UK
The Roles and Responsibilities of Wholesalers and 3PL Service Providers
  • Services offered
  • How to manage different clients and their requirements
  • Pick and pack – best practices
  • How to stay in compliance
GDP Audits
  • How to plan the Audit
  • Approach to GDP Audits
  • Reporting deficiencies
  • Examples of recent audit findings
What you need to know about 3PL Service Providers
  • Co-Operation
  • How 3PL service providers are organised
  • Contracts and qualification
Case Study: Management of a GMP Warehouse and Distribution of Medicinal Products with a 3PL-Approach
  • Outsourcing in Pharma Logistics – current trends & Benefits
  • Determining the scope of Outsourcing
  • Processes, roles & responsibilities
  • Monitoring of critical data
  • Reporting of the performance & controlling of the 3PL
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
Roles and Responsibilities of an RP and a QP
  • Responsible Person vs. Qualified Person
  • GDP vs. GMP
  • Product finishing activities
  • Product diversions
  • Handling of returned and damaged goods
  • Complaint Handling
Security in the Supply Chain – what is expected and how Industry is approaching it
  • FMD and its role in supply security
  • How can track and trace improve supply chain security
  • What is available and how to implement

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