GDP Newsletter

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[Dear Sir or Madam,

With this newsletter providing information on the latest developments and trends we would like to support you in implementing Good Distribution Practices.

Your ECA Team


1. Duties of the Responsible Person for GDP
 

In a course on 4-5 April 2017, the role and responsibilities of the Responsible Person for GDP will be highlighted and discussed. Please see the programme for further information.

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2. The Qualified Person: also responsible for Distribution Activities?

In his talk on "Detection of Falsified Medicines and how the QP can support this", Paul Hargreaves (MHRA), explored some facts that a QP should know when it comes to the falsification of medicines.

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3. Qualified Person Education Course
 

The European QP Association has developed an Education Course for new and future Qualified Persons to address general compulsory and regulatory issues. Discuss and convey possible solutions to problems addressed in case studies and workshops on 9-10 February 2017 in Barcelona. Please see the programme for further information.

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4. A 12 steps guide on how to choose the right Third Party Logistics (3PL) provider

Having in mind a proper needs assessment  many companies in the field are considering the outsourcing of their logistic activities. But when it comes to the decision making definite decisions are required. Support provides a 12-steps guide for the outsourcing of logistics activities.

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5. GDP Conference: GDP and the real World
 

The ECA GDP Association has set up a new GDP Conference on 14-15 February 2017 to inform about recent experiences made in the implementation of the EU GDP Guidelines. The conference also includes a site visit at the Perishable Center at Frankfurt Airport. Please see the programme for further information.

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6. Increasing Number of GDP Non-Compliance Certificates

The EudraGMDP Database contains GMP and GDP Compliance and Non-Compliance reports. From January 2016 until today six GDP non-compliance reports have been published. Please read more about the GDP Non-Compliance reports.

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7. GDP for APIs
 

This course from 28-29 March 2017 is intended to provide you with guidance on GDP for APIs. You will get to know the key aspects of the new EU GDP guidelines for APIs. Please see the programme for further information.

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8. Do you know the Saudi GDPs? And the Role of the Responsible Person?

The GDP Guidelines of the Saudi Food & Drug Authority (SFDA) have been published in English and are similar to those in the EU. But there are also some differences between the Saudi and the European GDP Guidelines.

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9. In case you missed the previous GMP Newsletter, here are the news from the last
    GMP Newsletter:

For further recent news please go here.

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10. Forthcoming GMP/FDA Events

Here you will find an updated overview of forthcoming education courses and conferences.

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Yours sincerely,

The ECA Academy


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