The Responsible Person for Good Distribution Practice (GDP) - Live Online Training

The Responsible Person for Good Distribution Practice (GDP) - Live Online Training

Kurs Nr. 19083

Alle weiteren Termine dieses Seminars finden Sie in dieser Übersicht.

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
Dr Afshin Hosseiny, Chair of the European GDP Association
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. Moreover, it should take into account the amendments to the Community Code which have been introduced with Directive 2011/62/EU of the European Parliament and of the Council. It is amending Directive 2001/83/EC on the Community code relating to medicinal products for human use with regard to preventing falsified medicinal products to enter the legal supply chain.

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 may delegate duties but not responsibilities. General requirements like organisational chart, job descriptions and tr

Target Group

This Live Online Training 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 for human use.

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

Programme Day 1 - 30 March 2022

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
  • What the Responsible Person (RP) needs to know about batch release
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
Programme Day 2 - 31 March 2022

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
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
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
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
  • What is available and how to implement
Question & Answer Sessions
A set of live Q&A Sessions will give you the possibility to interact with the speakers and get answers to your questions.
 
 

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