Dr Jens-Uwe Rengers
vorm. Akorn
Referierende
Dr Rainer Gnibl
GMP Inspector
Cheryl Chia
Lotus Phoenix Consulting
Alexandra Bauloye
Johnson & Johnson Innovative Medicine
Savvas Koulouridas
Fagron BV
Zielgruppe
- QPs, RPs, Managers and Executives from pharmaceutical Quality and Supply Chain Units
- Senior Management, Business Executives and those involved in improving and controlling the pharmaceutical supply chain
Zielsetzung
Discuss the latest expectations and best practices for effective and efficient Supply Chain Oversight processes and how to get there.
Background
There is a steady increase in dependence on global supply chains. Pharmaceutical companies not only source starting materials from all over the world, but also outsource manufacturing activities. The finished products are then distributed globally. These complex supply chains with different transport routes and manufacturing locations lead to major challenges in terms of maintaining the quality of materials, intermediates and medicinal products.
This has increased the risk of potential compliance and delivery problems, having a negative impact on a company's business and on the patient. Managing these supply chains and complying with GMP and GDP regulations require a comprehensive supply chain oversight with appropriate risk management measures.
Background
There is a steady increase in dependence on global supply chains. Pharmaceutical companies not only source starting materials from all over the world, but also outsource manufacturing activities. The finished products are then distributed globally. These complex supply chains with different transport routes and manufacturing locations lead to major challenges in terms of maintaining the quality of materials, intermediates and medicinal products.
This has increased the risk of potential compliance and delivery problems, having a negative impact on a company's business and on the patient. Managing these supply chains and complying with GMP and GDP regulations require a comprehensive supply chain oversight with appropriate risk management measures.
Programm
Highlights
- Regulatory and legal Background
- Control and Oversight
- Import/ Export
- Contracts
- Necessary GMP-Systems
Supply Chain Security: Regulatory Background
- Globalization: Challenge & risk also besides GMP/GDP
- Legal „oversight“ requirements
- Responsibilities
- GMP-/GDP interface
- What do inspectors expect?
- Which are the essential tools?
Other legal Aspects to consider
- The EU Supply Chain Act and its consequences for pharmaceutical companies (Corporate Sustainability Due Diligence Directive (CSDDD)
- EMA recommendations to strengthen supply chains of critical medicinal products and other necessary actions to avoid drug shortages (MSSG, CMA)
- Strategies to avoid drug shortages
Supplier Control
- How to keep oversight over the pool of suppliers and brokers
- Ongoing Supplier Qualification
- Active Supply Chain tracking
- Filing second source suppliers for APIs
Useful Supply Chain Diagrams
- Initiation and creation
- Management and change control
- Examples
Master Data in the Supply Chain
- The broader framework on Master Data
- How will this impact the pharmaceutical supply chain?
- What does this mean for supply chain organisations?
- What does this mean for the quality organisations supporting the supply chain?
- Become a master of your data!
Import and Export: Regulatory Perspective in EU
- Annex 16: Supply chain focus
- Annex 21: Consequences
- Inspector´s considerations on "best practices"
Contract Handling
- Different contracts in the Supply Chain (Forecasting, Supply, Quality/ Technical Agreement …)
- Who needs to sign
- Contract handling: how to keep them up to date, how to avoid contradictions
Risk Management in the Supply Chain
- Risk Management Framework to control quality, supply and business risks
- Risk Governance model
- Risk Register
- A view on Drug shortages: requirements and mitigation
Shipping Lane Risk Assessments
- Do we need them?
- What aspects of the shipping lane should be included?
- How much detail should be included?
- What actions might come out of the shipping lane assessment?
Weitere Informationen
Technical Requirements
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
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 will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference Language
The official conference language will be English.
Contacts
Question regarding content:
Wolfgang Schmitt,+49 6221 84 44-39, w.schmitt@concept-heidelberg.de
Questions regarding organisation:
Nicole Bach, +49 6221 84 44-22, nicole.bach@concept-heidelberg.de
Participant Feedback from previous Courses:
„Overall the whole course was a very interesting topic and provided a lot of valuable information on Q-Oversight and I would always recommend this course to others - to colleagues interested in Q-Oversight.”, Stefan Trentmann, DAIICHI SANKYO Europe GmbH, Germany
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
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 will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference Language
The official conference language will be English.
Contacts
Question regarding content:
Wolfgang Schmitt,+49 6221 84 44-39, w.schmitt@concept-heidelberg.de
Questions regarding organisation:
Nicole Bach, +49 6221 84 44-22, nicole.bach@concept-heidelberg.de
Participant Feedback from previous Courses:
„Overall the whole course was a very interesting topic and provided a lot of valuable information on Q-Oversight and I would always recommend this course to others - to colleagues interested in Q-Oversight.”, Stefan Trentmann, DAIICHI SANKYO Europe GmbH, Germany
Datum & Uhrzeiten
Tue, 29 June 2027, 09:00–17:00 h
(Registration and coffee 08:30–09:00 h
(Registration and coffee 08:30–09:00 h
Wed, 30 June 2027, 09:00–14:45 h
All times mentioned are CEST.
All times mentioned are CEST.
Teilnahmegebühr
| Reguläre Teilnahmegebühr*: | € 2090,- |
| ECA-Member Rabatt*: | € 1890,- |
| Teilnahmegebühr für Mitarbeiter/innen von GMP-Überwachungsbehörden*: | € 1045,- |
| APIC Member Rabatt*: | € 1990,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
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