Carsten Moschner
CMC3
Referent:innen
Dr Franz Schönfeld
Regierung von Oberfranken
Frank Denzler
Vetter Pharma-Fertigung
Dr. Manuel Hafner
Thermo Fischer Scientific
All times mentioned are CEST.
Zielsetzung
During this Live Online Training, experts from purchase, quality management, consultants and authorities will show you
- the critical fields of purchase and procurement for pharmaceutical manufacturing
- examples of the coordination and practical implementation of the GMP requirements on
- QC
- supplier qualification
- packaging materials
- maintenance. - how GDP affects procurement and purchase
And last but not least, the speaker team provides you with information about the expectations of the responsible authorities and the relevant Guidelines.
Hintergrund
During the last years, the developments of computer technologies gave purchasers a lot of possibilities to optimise content management and merchandise management, reduction of suppliers. Direct connection with suppliers’ systems enabled a faster, clearly arranged and more effective procurement. The World Wide Web, online tendering and auctions made the comparison of suppliers and costs easier than ever before.
But for the manufacturing of products under the regulations of drug licensing and GMP, like drug substances, drug products and medical devices, during all optimisation of purchase and procurement, purchasers must be aware of these regulatory requirements. Especially the change of suppliers, process relevant materials or parts of the qualified production plant must be planned in a direct cooperation with the quality management. Such changes necessities maybe a new validation of the process, a new qualification of the manufacturing plant and for sure, a change control procedure. This can affect additional costs, maybe more than the saving effect of the change and in a worst case; a not coordinated change can cause the lost of a product licensing.
But for the manufacturing of products under the regulations of drug licensing and GMP, like drug substances, drug products and medical devices, during all optimisation of purchase and procurement, purchasers must be aware of these regulatory requirements. Especially the change of suppliers, process relevant materials or parts of the qualified production plant must be planned in a direct cooperation with the quality management. Such changes necessities maybe a new validation of the process, a new qualification of the manufacturing plant and for sure, a change control procedure. This can affect additional costs, maybe more than the saving effect of the change and in a worst case; a not coordinated change can cause the lost of a product licensing.
Zielgruppe
This Live Online Training is for those who are involved in purchase and procurement for GMP regulated manufacturing as well as for responsible persons from QC and QA who are in cooperation with the purchase and procurement of their companies.
Technical Requirements
We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings 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.
Programm
Gesamtes Programm als PDF herunterladen
Procurement for GMP Manufacturing – Regulatory Requirements and Expectations
- Which regulations are applicable?
- Marketing authorisation
- Manufacturing and import licensing
- Supplier qualification: equipment, starting materials, disposables and consumables
- Risk-based qualification and validation
Consumables for GMP Areas – “C-items” and their Impact
- What impact do consumables have in terms of cost and quality?
- Specifications of the user and effective action of the purchasing Department
- Risk assessment and evaluation in the event of a possible product change (change control)
- Possible internal cots, depending on the respective consumable, in the case of a product change
GMP Requirements for Raw Materials
- What are raw materials?
- What is “pharmaceutical grade” for excipients?
- GMP for raw materials – risk assessment
- GMP requirements for final intermediate & APIs
- Supplier qualification & traceability
Requirements of Packaging Materials
- Liabilities
- Limitations
- The challenge for packaging purchasing
- Regulations and their requirements for packaging materials
- New products and their applicators
- Extended challenges for packaging purchasing
Supplier Contract Management
- Quality and risk Management
- Technical Agreements
- cGMP requirements
- Control of content
Change Control – Part I
- Impact and consequences
- Submissions – Friend or enemy?
- Why ignorance is dangerous
Change Control – Part II
Case Studies:
- Lectures from supply chain disruptions
- Why packaging can be a major headache
Documentation for GMP Materials – What is necessary? Retention Periods
- Regulatory requirements
- Defense against legal Claims
- Liabilities
- Limitations
Qualification of Technical Suppliers - a Risk-based Approach
- Technical equipment and utilities
- Analytical equipment & reagents
- Supplies, disposables and consumables - What regulations apply?
- Risk-based qualification and procurement
GDP Effects on Procurement and Purchase
- GDP requirements to manufacturer
- Ideas to handle the requirements
- Discussions between the involved departments
Supply Chain Improvement or Continuous (Process) Improvement - What is it? How can it be Implemented at 100% Capacity with Potential Regulatory Hurdles?
- What is Lean, Six Sigma, Scrum, Agile... and why the system doesn’t matter in the end
- Ideo, the design champions and what we can learn from them
- Why all this can actually be very simple. Improvements in purchasing and supply chain at 100% capacitiy and a completely regulated environment
Case Study: Time is Money – Reconstruction & Building of a Pharmaceutical Production
- Why this topic? - The special situation?
- Good start of the project! - a long time ago
- The arising budget issue!?
- The result of the different budget issue solutions!
- My key learnings - or perhaps “take home messages” for some participants.
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