Dr Franz Schönfeld
GMP Inspector
Referierende
Dr Reto Theiß
Merck Healthcare
Philipp Reusch
Reusch Rechtsanwaltsgesellschaft
Mukesh Patel
CommQP Pharmaceutical Services
Dr Melanie Distl
F. Hoffmann-La Roche
Zielgruppe
- Personnel involved in supplier qualification and decision-makers seeking to improve existing processes
- Intended for professionals from QA/QC, Procurement, Business Development, Manufacturing, Project Management and R&D
Zielsetzung
Learn the key aspects of implementing and improving a comprehensive, integrated supplier qualification system that fulfils regulatory GMP requirements. You will also learn about options and tools to increase efficiency and reduce costs in your Company.
Background
Supplier Qualification and audits of suppliers, contract manufacturers, laboratories and other service providers are an important part of every quality system. But what is required, and which steps are really necessary? Is it even possible to reduce audit activities?
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
- Procurement
- Objectives & priorities
- EU GMP Chapters and GMP processes applicable to Procurement
- GMP Training for the Buyer - Suppliers
- Supplier qualification
- Contracts
- Supplier categorisation
- Use of Brokers
Outsourcing to Contract Manufacturers and Laboratories - What Needs to be Considered and Who is Responsible?
- Regulatory Framework
- Regulations
- Outsourcing EU vs non-EU
- What if it goes wrong? - Outsourcing Life-Cycle Management
- Elements of Supplier Qualification
- Risk Assessment
- Technical Agreements
- Audits
Risk Management in the Supply Chain: Frequency of Supplier Audits based on Risk Assessment
- Frequency of Supplier Audits based on Risk Assessment
- Defining risk in the audit program
- Compliance risk assessment
Case Studies:
Qualifying and maintaining Suppliers at Roche
- Supplier Management embedded in PharmaTechOps and PQS
- Interface with other departments
- Example – Risk-based approach to Supplier Management at Roche
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
Examples and Interaction:
Quality Risk Management in the Supply Chain
Quality Risk Management in the Supply Chain
- Expectation of the Regulators
- Risk assessments
- Interactive Session
- Frequency of supplier audits based on risk assessment
Question and Answer Sessions
A set of live Q&A Sessions will give you the possibility to interact with the speakers and get answers to your Questions.
A set of live Q&A Sessions will give you the possibility to interact with the speakers and get answers to your Questions.
Weitere Informationen
Technical Requirements
Our live online training courses and webinars are conducted using Webex. At www.gmp-compliance.org/training/online-training-technical-information you will find all necessary information for participation, including a system check to verify whether your IT environment meets the technical requirements. If the installation of browser extensions is restricted due to internal IT policies, please contact your IT department. Webex is widely used, and installation is straightforward.
Fees (per delegate, plus VAT)
ECA Members EUR 1,890
QP Association Members EUR 1,890
APIC Members EUR 1,990
Non-ECA Members EUR 2,090
EU GMP Inspectorates EUR 1,045
The conference fee is payable in advance after receipt of invoice.
Presentations/Certificate
The presentations for this event will be available for you to download and print before and after the event. After the event, you will automatically receive your certificate of participation.
Conference Language
The official conference language will be English.
Contacts
Question regarding content:
Mr Wolfgang Schmitt,+49 6221 84 44-39, w.schmitt@concept-heidelberg.de
Questions regarding organisation:
Mr Rouwen Schopka, +49 6221 84 44-13, schopka@concept-heidelberg.de
Our live online training courses and webinars are conducted using Webex. At www.gmp-compliance.org/training/online-training-technical-information you will find all necessary information for participation, including a system check to verify whether your IT environment meets the technical requirements. If the installation of browser extensions is restricted due to internal IT policies, please contact your IT department. Webex is widely used, and installation is straightforward.
Fees (per delegate, plus VAT)
ECA Members EUR 1,890
QP Association Members EUR 1,890
APIC Members EUR 1,990
Non-ECA Members EUR 2,090
EU GMP Inspectorates EUR 1,045
The conference fee is payable in advance after receipt of invoice.
Presentations/Certificate
The presentations for this event will be available for you to download and print before and after the event. After the event, you will automatically receive your certificate of participation.
Conference Language
The official conference language will be English.
Contacts
Question regarding content:
Mr Wolfgang Schmitt,+49 6221 84 44-39, w.schmitt@concept-heidelberg.de
Questions regarding organisation:
Mr Rouwen Schopka, +49 6221 84 44-13, schopka@concept-heidelberg.de
Participant Feedback from previous Courses:
„I really enjoyed the topics, the way all the presentations have been structured as well as the way the questions have been answered.” Madalina Batista, IDT Biologika
“Very good content”, Fabiana Frech
„I really enjoyed the topics, the way all the presentations have been structured as well as the way the questions have been answered.” Madalina Batista, IDT Biologika
“Very good content”, Fabiana Frech
Datum & Uhrzeiten
Wed, 17 March 2027, 09:00–16:45 h
Thu, 18 March 2027, 09:00–15:30 h
All times mentioned are CET.
Thu, 18 March 2027, 09:00–15:30 h
All times mentioned are CET.
Teilnahmegebühr
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
| European QP Member Discount*: | € 1890,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Aufzeichnung nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified GMP Auditor"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
Teilnehmerstimmen
Teilnehmerstimmen - das sagen andere über unsere Seminare:
