header-image

Live Online Training: GDP in Switzerland (GDP 3)

Tuesday, 1 September 2020

Seminar-Nr. 18213

Referent:innen

Dr Ina Bach

Dr Ina Bach

Dr. Bach

Dr Johannes Fröhlich

Dr Johannes Fröhlich

Akroswiss

Felix Kesselring

Felix Kesselring

Bratschi Rechtsanwälte

Dr Remo Studer

Dr Remo Studer

Galexis

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.

Hintergrund

Quality requirements for medicines do not end after production and packaging. Medicines and APIs are often shipped over long distances and different climate zones and stored in various warehouses. Once the WHO has taken the lead with its guidelines „Good Storage Practices for Pharmaceuticals“ (2003) and „Good Distribution Practices for Pharmaceutical Products“ (2010), more and more compliance with good storage, transportation and distribution practice was emphasised worldwide. Another milestone were the EU-GDP guidelines from 2013 with a lot of intensified demands.
 
For quite a while it was rather unclear how these guidelines are applicable in the non-EU country Switzerland. Under the Agreement of 21 June 1999 between the Swiss Confederation and the European Community (Mutual Recognition Agreement, MRA), Switzerland obliged to comply with the EU-GMP regulation. However GDP was not covered.
 
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 Establ ishmentLicences(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. Various transitional provisions for licenses issued under the old legislation are defined. However, for all new/renewed applications, the new legislation will apply in its entirety.

Zielgruppe

This Live Online Training 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.

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.

Programm

Live Online Training: GDP in Switzerland (GDP 3)

Gesamtes Programm als PDF herunterladen

09.00 – 09.10 h
Introduction

09.10 – 10.00 h
Legal Bases for the Distribution of Medicinal Products
  • Legal basis in Switzerland including EU regulations
  • The Ordinance on Establishment Licences OEL (AMBV, OAMéd)
  • The revised Therapeutic Products Act (HMG 2): relevant changes
  • GMP/GDP Interface
  • Working with contractors
10.00 – 10.20 h
Break

10.20 – 11.40 h
Tasks and Responsibilities
  • Requirements and due diligence for the Responsible Person according Art. 9 and 13 of the Ordinance on Establishment Licences
  • Storage and distribution: current expectations
  • Cross-border Distribution: Requirements for Import andExport
  • Requirements for specific products
  • Qualification of suppliers and recipients
  • Senior Management
  • Responsible Person
11.40 – 12.30 h
Liability
  • Principles of liability
  • Who is liable?
  • Potential sanctions
  • Examples from the real life, case law

12.30 – 13.30 h
Break

13.30 – 15.30 h
Storage and Transport: Practical Aspects
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
15.30 – 15.50 h
Break

15.50 – 17.15 h
Practical Implementation in Switzerland
  • The GDP Inspection: what do inspectorates expect and how to prepare
  • Wholesaler vs. Pre-Wholesaler: interfaces and delimitation
  • Transport at storage conditions: best practices
  • Case Study: transport validation
17.15 – 17.30 h
Final Discussion

Dieses Seminar/Webinar kann nicht gebucht werden. Alternative Termine für dieses Seminar/Webinar und ähnliche Veranstaltungen finden Sie in der Liste aller Seminare.

Für viele Seminare und Webinare gibt es auch Aufzeichnungen, die Sie jederzeit bestellen und anschauen können. Diese Aufzeichnungen finden Sie in der Liste aller Aufzeichnungen.

Oder senden Sie uns Ihre Anfrage einfach über das folgende Kontaktformular.

* auch unkompliziert per Kreditkarte bezahlbar
American Express Visa Mastercard

icon
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
icon
Weitere Termine online
Weitere Termine online nicht verfügbar
icon
Aufzeichnung nicht verfügbar

Haben Sie noch Fragen?

Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de

Frau mit Headset

Zurück

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