Live Online Training: Procurement and Purchase meet GMP Im Auftrag der ECA Academy

Live Online Training: Procurement and Purchase meet GMP Im Auftrag der ECA Academy

Kurs Nr. 18998

Alle weiteren Termine dieses Seminars finden Sie in dieser Übersicht.

Kosten

ECA-Member: EUR 1590,--
Non ECA Member: EUR 1790,--
EU/GMP Inspectorates: EUR 895,--
APIC Member Discount: EUR 1690,--

Alle Preise zzgl. MwSt.

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Speakers

Dr Frank Denzler, Vetter Pharma Fertigung GmbH & Co. KG, Germany
Dr Hiltrud Horn, Horn Pharmaceutical Consulting, Germany
Carsten Moschner, Dastex, Germany
Stephan Schmitt-Koopmann, sk pharma consulting, Switzerland
Dr Franz Schönfeld, GMP Inspectorate Upper Franconia, Germany

Objectives

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.

Background

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.

Target Group

This Live Online Training is for people 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

For our Live Online Training Courses and 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.

Programme

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
Where does GMP start? Procurement for Development and Clinical Phases
  •  Considerations for EU and USA?
  •  Why should we know ICH Q7, Q8, Q9, Q10 and Q11?
  •  What is essential for development?
  •  Changes for routine manufacturing?
  •  Case study
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
  •  What does it mean?
  •  Impact and Consequences?
  •  Examples for Typical Changes
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

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