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GDP in Switzerland (GDP 3)

12 September 2024, Basel, Switzerland

Seminar-Nr. 21328

Zielsetzung

  • Learn and discuss how to manage your distribution activities GDP-compliant.
  • Exchange opinions and convey possible solutions to problems addressed in case studies.
  • Benefit from the speakers’ experience in industry, authority and legal advice.
Since 1 July 2015, the EU GDP guidelines do also apply for Switzerland (final implementation on January 1st 2016). This was realised through an adaptation of Annex 2 of Ordinance on EstablishmentLicences(Arzneimittel-Bewilligungsverordnung - AMBV or Ordonnance sur les autorisations dans le domaine des médicaments - OAMéd).

On 1 January 2019, the revised Therapeutic Products Act (HMG 2) and the majority of the revised implementing ordinances
(Therapeutic Products Ordinance Package IV) came into force - with some interesting changes.
 
Holders of an operating license for wholesale activities are obliged to designate a Responsible Person (“Fachtechnisch Verantwortliche Person, FvP)”.
 
The requirements for a Responsible Person are described in the Ordinance on Establishment Licences.

Zielgruppe

This course has been designed for employees, specialists and managers from storage, transportation and distribution as well as their colleagues from quality control, quality assurance and production, which are involved in the various processes of drug logistics.

Important Information

The presentations of this GDP Course will be available for download and your print-out one week before the conference. Note: there will be no print-outs available during the course.

Programm

GDP in Switzerland (GDP 3)

Gesamtes Programm als PDF herunterladen

Legal Bases for the Distribution of Medicinal Products
  • Swiss Law and European Law
    - Act on Therapeutic Products
    - Ordinance on Establishment Licences
    - European Guidelines on Good Distribution Practice of Medicinal Products for Human Use (GDP)
    - European GDP Guidelines for Active Substances
  • Outsourced activities
  • Written contract for outsourced activities
Tasks and Responsibilities
  • General considerations on GDP in Switzerland
  • Legal Basis
  • Revision of the Therapeutic Products Act (HMG) and ist effects
  • Authorization types
  • GDP Requirements
  • Quality in the supply chain
  • Technically Responsible Person (FvP) - General
  • FvP - Delegation
Liability
  • Responsibility and liability: Terms
  • Different kinds of responsibilities
    - Administrative responsibility
    - Civil responsibility
    - Criminal responsibility
  • Protection of the Responsible Person
  • The Responsible Person in case law
Practical Implementation in Switzerland
  • The GDP inspection: preparation and implementation
  • Wholesale vs. pre-wholesale: demarcation and similarities
  • Transport in accordance with storage conditions: best practices
  • Case study: validation of transport routes, qualification of transport vehicles
Storage and Transport: Practical Aspects (Interactive Session)
 
a) Warehouse
- Requirements
- Qualification
- Mapping
- Hygiene
- Documentation
 
b) Transport
- Transport qualification/ validation
- Transport at ambient conditions: expectations and control
- Deviation management
- Cool and cold chain
- Risk Analysis
- Training

Regular Fee*: € 1290,-
EU/GMP Inspectorates*: € 645,-
GDP Association Member Discount*: € 1090,-

Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.

* auch unkompliziert per Kreditkarte bezahlbar
American Express Visa Mastercard

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Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de

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Teilnehmerstimmen - das sagen andere über unsere Seminare:

Guter, breit gefächerter Überblick mit interessanten Verknüpfungen zur Praxis,
welche die Theorie super veranschaulicht.”
Marina Kicoranovic, Labor Hartmann GmbH
GMP/Basis-Einstiegsschulung (B 14), September 2023

Die Referenten waren sehr gut! Sie haben sehr klar gesprochen, nur sehr wenige englische Begriffe
verwendet (super) und waren sehr praxisbezogen.”
Astrid Gießler, Regierungspräsidium Karlsruhe
Live Online Seminar - Basiskurs Computervalidierung & Datenintegrität im GxP Umfeld (B 3), Juni 2023

Sehr guter Bezug zur Schulung für einen GMP-Anfänger. Habe mich sehr gut abgeholt gefühlt.”
Dr. Harald Werner, Infraserv GmbH & Co. Höchst KG
GMP-Basisschulung (B 1), Juni 2023