Cheryl Chia, Lotus Phoenix Consulting, Netherlands
Simon Dössegger, Modum.io, Switzerland
Loretta Dougan, Jazz Pharmaceuticals, Ireland
Ulrich Kissel, European QP Association, EQPA Chairman of the Board of Directors
Mervi Saukkosaari, Finnish Medicines Agency FIMEA
This 2-day Live Online Training brings together well-experienced experts to discuss the latest expectations and best practices for effective and efficient Supply Chain Oversight processes and how to get there.
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.
The manufacturer, the Qualified Person (QP) but also the Responsible Person (RP) are primarily responsible for compliance with EU/EEA requirements:
- EU-GMP Annex 16, General principles: “The ultimate responsibility for the performance of a medicinal product over its lifetime, its safety, quality and efficacy, lies with the marketing authorisation holder (MAH).”
- EU-GMP Annex 16, 1.7.2: “The entire supply chain of the active substance and medicinal product up to the stage of certification is documented and available for the QP. This should include the manufacturing sites of the starting materials and packaging materials for the medicinal product and any other materials deemed critical through a risk assessment of the manufacturing process. The document should preferably be in the format of a comprehensive diagram…”
In the meantime, the competent authorities and inspectorates are also focusing on supply chain oversight processes; manufacturers and especially the marketing authorisation holder must know and control every level of the supply chain.
QPs, RPs, Managers and Executives from pharmaceutical Quality and Supply Chain Units but also Senior Management, Business Executives and those involved in improving and controlling the pharmaceutical supply chain.
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.
Regulatory Background and the GMP/GDP Interface
- Responsibilities of MAH, QP and RP in the overall supply chain
- What do inspectors expect?
Supply Chain Oversight (1): from Development to Transfer
- How to keep oversight over the pool of suppliers and brokers in the development phase (supplier change controls, ongoing supplier management incl. trending)
- Initiation, creation and management of compliant and useful supply chain diagrams (with examples)
- How to use risk analysis and management
- Transfer of the information: the “QP-QP handshake”
Supply Chain Oversight (2): from Transfer to Life Cycle Management
- Transfer of the information: the “QP-QP handshake”
- Management and change control of compliant and useful supply chain diagrams (with examples)
- How to keep oversight over the pool of suppliers and brokers in the marketing phase (supplier change controls, ongoing supplier management incl. trending)
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!
Block Chain Technology in the Supply Chain
- What is block chain and how could it help supply chains?
- Block chain for supply chains – a must or a maybe?
- Examples of block chain being used in supply chains
- Understand the components of the supply chain based on a hypothetical example (Material flow, Information flow, Capital flow)
- Barriers, challenges and solutions.
- Challenges and problems occurring in the supply chain and how to deal with them
Import and Export
- Annex 21: possible consequences
- The Release to third Countries
- Who is releasing products in markets outside EU (after EU QP certification) – and how
- Best practices - what needs to be considered
- 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
Change Control and Certification for global Markets
- How to deal with change control challenges when regular approvals can take several months or years to cover all the relevant countries worldwide
- How to support decision making
- The link to ICH Q12
From Incident to Quality Review
- Different types of queries/complaints
- Who deals with which types of queries/complaints?
- Examples of distribution complaints
- Investigation and CAPAs
- Quality Reviews