The Responsible Person for Good Distribution Practices (GDP)

The Responsible Person for Good Distribution Practices (GDP)

Berlin, Germany

Course No 15582


Costs

Non-ECA Members: EUR 1790,--
ECA Members: EUR 1590,--
EU GMP Inspectorates: EUR 895,--
APIC Members (does not include ECA membership): EUR 1690,--
QP Association Members: 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

Dr Afshin Hosseiny, Chair of the ECA Working Group on GDP

Dr Daniel Müller, GMP/GDP Inspector

Dr. Martin Egger, Pharmaserv

Dr Laura Ribeiro, ID Logistics

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

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 for human use.

GDP Compliance Toolkit

All participants will receive a Roadmap to Good Distribution Practice containing:
An Overview of the designated Responsibilities
A Checklist for the Implementation of GDP Principles

Programme

The EU GDP Guidelines

  • The counterfeit directive and 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
The Role of the RP in Approval Deliveries/ Products for Distribution
  • What does batch release mean?
  • Responsible Person (RP) vs. Qualified Person (QP)
  • What the Responsible Person (RP) needs to know about batch release
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
Experiences from GMDP Inspections
  • Frequent Findings
  • Expectations with regard to the Responsible Person
Controlled Temperature Distribution
  • How to manage cold chain products
  • How to manage 15 - 25 °C requirements
  • Temperature monitoring or control - what is the best option for the product?
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
Roles and Responsibilities of an RP and a QP (Interactive Session)
Responsible Person vs. Qualified Person
Pharmaceutical vs. nutritional products
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
  • Track and Trace
  • Recent developments
  • How can track and trace support anti-counterfeiting requirements
  • Current technologies

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