header-image

Efficient Supplier Qualification - Online Training Recording

Seminar-Nr. 20154A

Referent:innen

Dr. Franz Schönfeld

Dr. Franz Schönfeld

Regierung von Oberfranken

Dr Reto Theiß

Dr Reto Theiß

Merck Healthcare

Philipp Reusch

Philipp Reusch

Reusch Rechtsanwaltsgesellschaft

Mukesh Patel

Mukesh Patel

CommQP Pharmaceutical Services

Dr Melanie Distl

Dr Melanie Distl

F. Hoffmann-La Roche

Zielsetzung

During this course, you will learn all relevant aspects to implement and/ or improve a comprehensive and integrated Supplier Qualification System which fulfils regulatory GMP requirements. Furthermore, you will get to know possibilities and tools to increase efficiency and decrease costs at your company.

Hintergrund

Qualification and audits of suppliers, contract manufacturers and laboratories and other service providers are an important part of each Quality System. But what is required and which steps are really necessary? And is it possible to even decrease audit activities?

Starting materials should only be purchased from approved suppliers. EU Directive 2004/27/EC states that the manufacturer shall only use active substances, which have been manufactured in accordance with the detailed guidelines on GMP for starting materials. But also in contract manufacture and analysis, the contract giver is responsible for assessing the legality, suitability and the competence of the contract acceptor to follow GMP (EU Guide to GMP [7.5]).

The requirements and efforts to qualify suppliers should therefore not be underestimated. However, it seems that a downright ‘audit tourism’ has grown and suppliers and service providers are audited on site frequently and sometimes too often. In the globalising world more and more supplies are coming from countries like India and China. And qualifying these suppliers brings new challenges. This adds up to significant expenses for both the audited and the auditing company.

But supplier qualification is not limited to auditing. The whole process of supplier qualification and co-operation should be integrated in the existing Quality System of a company.

Zielgruppe

This course and its pre-course session are designed for all personnel involved in supplier qualification activities at their company and decision makers who want to improve the existing process. It is addressed to persons from Quality Assurance and Control, Procurement, Business Development, Manufacturing, Project Management and R&D.

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.

Please be aware: The recording does not include the Q & A sessions.

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

The Objective of Supplier Qualification
  • Regulatory Background
  • Duties and responsibilities of the QP
  • Expectations of the authorities
  • Importing Active Pharmaceutical Ingredients into the European Union
International Trade Relations – What you Need to Know
  • International trade law
  • Applicable commercial Legislation
  • Jurisdiction
  • Incoterms
  • Responsibilities
GMP Pre-Requisites for Procurement and Outsourcing Activities
  • GMP training for procurement staff
  • Dealing with brokers
  • Contracts
  • Change Control
  • Complaints
  • Roles and responsibilities
Outsourcing to Contract Manufacturers and Laboratories - What Needs to be Considered and Who is Responsible?
  • What activities can you out-source?
  • Differences when outsourcing within the EU compared to outside of the EU
  • Initiation and Contents of the Technical Agreements
  • Validation activities: tasks and responsibilities
  • GMP/GDP interface
  • Legal and ethical responsibilities
  • What can happen when things go wrong?
Case Studies:
When Things go Wrong
  • Quality Risk Management to avoid delivery bottlenecks and drug shortage
A Modular System for Qualifying and Maintaining Suppliers
  • Integrating supplier qualification in the pharmaceutical quality System
  • Interfaces with other Departments
  • Examples
Reduced Testing of Supplied APIs and Excipients
  • What guidance is available on reduced QC testing?
  • EU and FDA expectations
  • Information required before you start reducing
  • Can APIs and excipients be covered within the same approach?
  • Practical execution
Risk Management in the Supply Chain: Frequency of Supplier Audits based on Risk Assessment
An interactive session to establish where to best concentrate your resources to maximise the assurance of a reliable supply chain:
  • Frequency of Supplier Audits based on Risk Assessment
  • Defining risk in the audit program
  • Compliance risk assessment
Recording from 15/16 March 2023
Duration of the recording: approx. 8.5 hours

 

ECA-Member*: € 1490,-
Regular Fee*: € 1690,-
EU/GMP Inspectorates*: € 845,-
APIC Member Discount*: € 1590,-
QP Member Discount*: € 1490,-

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