Recording Online Training: The Responsible Person for Good Distribution Practice (GDP)<br>Im Auftrag der ECA Academy

Recording Online Training: The Responsible Person for Good Distribution Practice (GDP)<br>Im Auftrag der ECA Academy

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.

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

Sprecher

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

Zielsetzung

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.

Hintergrund

In 2013 the new ‘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 training requirements are new or outlined in much more detail.

Zielgruppe

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.

Technische Details

Um an einem On-Demand-Training oder Webinar teilzunehmen, benötigen Sie keine Software. Die Aufzeichnungen werden über einen Streaming-Server zur Verfügung gestellt. In der Regel wird die Aufzeichnung im MP4-Format bereitgestellt, das jeder PC (Microsoft Windows, Apple IOS) oder jedes Tablet problemlos darstellen kann.

Zeitplan und Dauer:
Wenn Sie sich für ein On-Demand-Seminar oder -Webinar registrieren, können Sie entscheiden, zu welchem Zeitpunkt Sie sich das Seminar online anschauen möchten. Bei einer 1-Tages-Schulung haben Sie 2 Tage, in denen der Stream zur Verfügung steht (bei einer 2-Tages-Schulung 3 Tage und bei einer 3-Tages-Schulung 4 Tage). Innerhalb dieses Zeitraums können Sie den Stream je nach Bedarf starten und stoppen.

Rechtzeitig vor dem geplanten Termin (Ihrem Wunschtermin) erhalten Sie von uns eine E-Mail mit einem Link zur direkten Teilnahme sowie Ihren Log-in-Daten.

Präsentationen und Zertifikat:
Die Präsentationen werden Ihnen kurz vor dem Online Seminar als PDF-Datei zur Verfügung gestellt. Jede/r Teilnehmer/in erhält im Anschluss an das Seminar ein Teilnahmezertifikat zugesandt.

Programm

Programme Day 1 

Welcome and Introduction

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
  • Inspections of the competent authorities
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
  • Frequent Findings
  • Expectations with regard to the Responsible Person
The Role of the Responsible Person in Management of Export and Import to and from UK
  • What does batch release mean?
  • Responsible Person (RP) vs. Qualified Person (QP)
  • Brexit and its impact on supply chain
  • Export and import to and from UK
  • How does RP discharge its responsibilities post Brexit
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
Final Discussion Day 1

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
  • Track and Trace
  • Recent developments
  • How can track and trace support anti-counterfeiting requirements
  • Current technologies
Final Discussion Day 2
 
Aufzeichnung vom 24.03.2021
Dauer der Aufzeichnung: ca. 10,5 Std

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