|Non-ECA Members:||EUR 1790,--|
|ECA Members:||EUR 1590,--|
|EU GMP Inspectorates:||EUR 895,--|
|APIC Members (does not include ECA membership):||EUR 1690,--|
(All prices excl. VAT)
If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: firstname.lastname@example.org
During this course, experts from purchase, quality management, consultants and authorities will show you the critical fields of purchase and procurement for pharmaceutical manufacturing. Furthermore you become acquainted with examples of the coordination and practical implementation of the GMP requirements on QC, supplier qualification, packaging materials and maintenance. And last but not least, the speaker team provides you with information about the expectations of the responsible authorities and the relevant guidelines.
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 supplier 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 effect additional costs, maybe more then the saving effect of the change and in a worst case, a not coordinated change can cause the lost of a product licensing.
This course 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.
Procurement for GMP manufacturing – Regulatory Requirements and Expectations