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

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

Course No 18642

All times mentioned are CET.

Costs

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,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

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 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.

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 

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

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