header-image

The QP in Switzerland - Online Training Recording

Seminar-Nr. 18090A

Referent:innen

Dr Karin Hofstetter

Dr Karin Hofstetter

BioAtrium

Dr Carsten Meininghaus

Dr Carsten Meininghaus

DSM Nutritional Products

Dr Ina Bach

Dr Ina Bach

Dr. Bach

Dr. Ulrich Kissel

Dr. Ulrich Kissel

European QP Association (EQPA), KisselPharmaConsulting

Dr. Tillmann Lindenblatt

Dr. Tillmann Lindenblatt

Fisher Clinical Services

Zielsetzung

  • Learn and discuss the special tasks and responsibilities of the Responsible Person (RP) in Switzerland (Qualified Person/ QP according EU legislation).
  • Exchange opinions and convey possible solutions to problems addressed in case studies and workshops.
  • Benefit from the speakers’ experience in industry, authority and legal advice.

Hintergrund

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. This means that the GMP requirements of Directive 2001/83 / EC (in particular Article 46. to 52 for the QP) also apply in Switzerland.

The requirements for a Responsible Person (“Fachtechnisch Verantwortliche Person” in the German speaking part) are described in art. 5, art. 10, art. 14 and art. 15 of the Ordinance on Establishment Licences. With its signature, the RP confirms that a batch meets the specifications and has been manufactured in a GMP-compliant system. This system-related statement is considerably more comprehensive than a batch-related confirmation, which aims solely to comply with the specifications. Therefore the duties and responsibilities can be rather extensive.

In January 2019, the revised Therapeutic Products Act (HMG 2) and amendments to the ordinances (Therapeutic Products Ordinance Package IV) came into force - with some interesting alterations.

Zielgruppe

Responsible Persons/ RPs for batch certification and release and Executives and Managers who want to get an overview on the duties and responsibilities of the RP.

Technical Details

To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.

Timing and Duration:

When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.

In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.

Training Course Documentation and Certificate:

The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.

Programm

EU Regulations and their Implementation in Switzerland
  • Directive 2001/83/EG and the Qualified Person
  • Mutual Recognition Agreement
  • Ordinance on Establishment Licences OEL (AMBV,  OAMéd)
Role and Tasks of the Responsible Person
  • The role in the company and the organisation chart
  • Batch certification and release
  • Cross-boarder activities
  • Personal duties and responsibilities
  • Delegation
  • Deputies
  • Internal delimitation of responsibilities
  • Contract RPs
Examples: Certification and Batch Release
  • To certify or not, that’s the question
  • Decision making process
The GMP/GDP Interface
  • Consequences of the Therapeutic Products Act and amendments to Ordinances
  • Storage and transport
  • Import and export: particularities
  • Cool and cold chain issues
  • Supply chain traceability
Outsourcing: What the RP should know about assuring Product Quality
  • Compliance with the registration
  • Compliance with GMP
  • Audits and supplier qualification
  • Necessary batch documentation
  • Product Quality Review (PQR)
  • Delimitation of Responsibilities in the supply chain
  • Quality (Technical) Agreement
The API Supply Chain
  • Requirements in Switzerland and the EU
  • Responsibilities of the RP
  • Questions, challenges and solutions
The Responsible Person’s daily Work: what the RP need to know about:
  • Communication and collaboration with the authorities
  • Risk Management
  • KPIs
  • Management Review
Liability
  • Principles of liability
  • When will the RP be liable?
  • Potential sanctions
  • Examples from the real life, case law
Examples: Quality Control and Laboratory
  • What the RP needs to know
  • Responsibilities
  • OOS, OOE und OOT
  • Fault analysis
  • Statistics
Recording from 03.06.2020
Duration of the recording: approx. 8 hours 

Regular Fee*: € 1490,-
QP Member Discount*: € 1390,-

Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.

* 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

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:

"Die Umsetzung mit Memberspot ist wirklich ausgezeichnet gelungen.
Es unterstützt die Wissensvermittlung und gewährleistet auch die richtige Durchführung des Kurses.”
Christian Wagener, WAGENER & CO. GmbH
GMP Basis-Einstiegsschulung (B 1) - Aufzeichnung Online Seminar, April 2024

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

„Interessante Themen, gut vorgetragen, die eigenen Erfahrungen der Vortragenden helfen, dies noch besser nachzuvollziehen.“ „Gute Gestaltung der Workshops, das Zusammenarbeiten in Gruppen und der Austausch mit anderen hilft sehr.“
Manuela Seibert, Merck, GMP-Leadauditor/in (FA 2), April 2024

NEWSLETTER

Bleiben Sie informiert mit dem GMP Newsletter von Concept Heidelberg!

GMP Newsletter

Concept Heidelberg bietet verschieden GMP Newsletter die Sie auf Ihren Bedarf hin zusammenstellen können.

Hier können Sie sich kostenfrei registrieren.

Kontakt

Kontaktieren Sie uns

Haben Sie Fragen?

Concept Heidelberg GmbH
Rischerstraße 8
69123 Heidelberg

Tel. :+49622184440
Fax : +49 6221 84 44 84
E-Mail: info@concept-heidelberg.de

zum Kontaktformular