Webinar - IPEC Significant Change Guide

Category: IPEC Europe
  • Online event
  • 21 Nov 2023

DATE AND TIME: Tuesday 21 November 2023, 15:00-15:40 CET - Check local times

The IPEC Significant Change Guide for Pharmaceutical Excipients provides a consistent approach to evaluate the significance of changes with regard to the manufacture and the distribution of excipients.

The 2023 revision of the guide has retained much of the original content but has been updated to better align with the general guideline policies and format requirements of IPEC. These updates include harmonized terminology and general statements, the relocation of content to more relevant sections, and the incorporation of decision trees into the main body of the guide.

This webinar aims to provide a practical approach to the Significant Change guide. Different scenarios and practical examples will be presented and discussed to deepen the understanding of GMP-compliant requirements for excipient manufacturing and distribution. This involves considering both the requirements of the users and the constraints of the manufacturers.

The webinar is free of charge for IPEC Europe Members.


Darek Lewin, Head of Quality, J. Rettenmaier & Söhne GmbH + Co KG (JRS Pharma)

Darek Lewin graduated in “Technology of Renewable Raw Materials” in 2001 at the University of Applied Sciences Hannover. In 2003, he was employed as the Project Manager for “Microencapsulation of Probiotic Bacteria” at J. Rettenmaier & Söhne GmbH & Co KG, Rosenberg, Germany, a world-wide, dynamic leader in the fiber industry. JRS provides with their fiber products solutions for various applications and chemical processes for almost every field of daily life, i.e. for pharmaceutical and food applications, or for technical and industrial use. From 2004 to 2006, he was responsible as the Food and Feed Safety Manager and then as Corporate Quality Manager for JRS Pharma GmbH & Co KG. JRS Pharma is currently the biggest producer of Microcrystalline Cellulose worldwide. Additionally, JRS Pharma serves the pharmaceutical industry with a family of high functional solid excipients. Since 2007, Darek Lewin is the Head of Quality for the JRS Group with production plants in Europe, USA, India, China and Mexico.


IPEC Europe Members : Free of charge
General Admission: 80 €

All fees VAT excl. Belgian VAT applicable for Belgian-based participants.