IPEC e-newsletter - Excipients Insight November 2017 - 22-11-17

 

Inside this issue

     

IPEC Europe webinar - Quality Agreement and Templates Guide 2017

IPEC Europe is pleased to announce its new webinar on 23 November 2017, 15:00-16:00 CET.

The webinar will present the Quality Agreement Guide and Template(s) for Pharmaceutical Excipients 2017 that will be published and available to download free-of-charge on Monday 13 November.

Register and receive best practices and guidance on the content of an excipient Quality Agreement. Excipient suppliers will be introduced to the process of preparing their own Quality Agreement Template according to company standards, as the template format is intended to be flexible.

The concepts of what should be in such Quality Agreements have been explained in the 2009 IPEC Quality Agreement Guide and Templates. However, with new regulatory requirements and ever more complex supply chains, this Guide had been revised by a team of IPEC experts to provide practical and detailed guidance on how to meet all of these challenges. This new version considers EXCiPACT and ANSI certification standards, which are increasingly recognised as a means of demonstrating that suppliers operate in conformance with excipient GMP. And very significantly, to help ensure both final customers’ and manufacturers’ needs are addressed when the customer buys from a distributor, this revision introduces the innovative concept of Manufacturer’s Quality Statement template.

This webinar will serve as a good introduction to those who have recently become engaged in customer/user management and for experienced professionals, a refresher on the latest developments in this important area.

The webinar will be hosted by Astrid Stockrahm-Uhling of DFE Pharma. Astrid has significant experience in this field and also led the task force responsible for the revision of the 2009 Quality Agreement Guide. After Astrid reviews current perspectives on this topic, participants can engage in a live interactive session adding to the learning experience!

Registration fee

  • IPEC Europe members: €50 excl. VAT (21%)
  • Non-Members: €75 excl. VAT (21%)

More details and registration here.

 

 

 

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