Dr. Daniel Müller
GMP Inspector
Referent:innen
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 “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.
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 should have appropriate competence and experience as well as knowledge of and training in GDP. He or she may delegate duties but not responsibilities. The RP should carry out their duties in such a way as to ensure that the wholesale distributor can demonstrate GDP compliance and that public service obligations are met.
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 should have appropriate competence and experience as well as knowledge of and training in GDP. He or she may delegate duties but not responsibilities. The RP should carry out their duties in such a way as to ensure that the wholesale distributor can demonstrate GDP compliance and that public service obligations are met.
Zielgruppe
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.
Roadmap to Good Distribution Practice
All participants receive a Roadmap to Good Distribution Practice containing:
- An overview of the designated Responsibilities for Senior Management, Responsible Person and Authority
- Checklist for the implementation of GDP principles
Programm
Gesamtes Programm als PDF herunterladen
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
What is the RP and Wholesaling
- Qualification and experience requirements for RP
- The Role of RP in management of export & Import
- Annex 21: Importation of medicinal products
- Export & import to and from EU
Experiences from GMDP Inspections
- Inspections of the competent authorities
- Typical GDP inspection findings
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
GDP Audits
- How to plan the Audit
- Approach to GDP Audits
- Reporting deficiencies
- Examples of recent audit findings
Roles and Responsibilities of the RP
- Qualifications requirements for RPs
- Responsible Person vs. Qualified Person
- GDP vs. GMP
- Duties and Delegation
- How to discharge your duties
- Handling of returned and damaged goods
- Complaint Handling
Validation of Computerized Systems under GDP Regulation
- Validation requirements – regulatory overview
- GAMP oriented validation approach of GDP critical systems
Case Study: Validation of a new Warehouse and Material Management System
- Wholesaler in Germany
Workshop: Deviation Management
During this workshop participants will learn and discuss how to ensure that the deviation System is being correctly used and implemented.
During this workshop participants will learn and discuss how to ensure that the deviation System is being correctly used and implemented.
Security in the Supply Chain
- Counterfeit / falsified pharmaceuticals – a real threat!
- What is pharma industry doing about it?
- Recent developments
- How can track & trace support anti-counterfeiting requirements
| ECA-Member*: | € 1690,- |
| Non ECA Member*: | € 1890,- |
| EU/GMP Inspectorates*: | € 945,- |
| APIC Member Discount*: | € 1790,- |
| GDP Association Member Discount*: | € 1690,- |
| QP Member Discount*: | € 1690,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de
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