Webinar - IPEC GDP Audit Guide

Category: IPEC Europe
  • Online event
  • 7 Dec 2021

Date:  Tuesday 7 December 2021 - 15:00-16:00 CET

The webinar will provide an overview of the recently updated IPEC GDP Audit Guide for Pharmaceutical Excipients 2021.

The revised Audit Guide provides a comprehensive tool together with the related IPEC GDP Guide 2017 for companies auditing the supply chain of pharmaceutical excipients, and is a valuable tool to help auditors conduct a complete audit of all relevant GDP principles for pharmaceutical excipients.

Several incidents in the past were caused by a lack of supply chain security and inappropriate handling of pharmaceutical excipients; this initiated the development of guidelines and principles of GDP to mitigate the risks to excipient safety and quality throughout the supply chain.

The webinar will present the content and the use of the GDP Audit Guide in conjunction with the IPEC GDP Guide.

Learning objectives

Attendees will be able to:

  • Understand general aspects of GDP in the excipient supply chain
  • Understand how the GDP Audit guide relates to the GDP guide
  • Become familiar with structure, content and use of the GDP Audit Guide.

Target audience

  • Excipient manufacturers and distributors
  • Excipient users
  • QA and RA representatives
  • Internal auditors and supplier auditors

Presenter: Dr. Frank Milek, IPEC Europe Vice-Chair and GDP Committee Chair, Aug. Hedinger GmbH & Co. KG

Frank Milek is an industrial pharmacist. He is PhD pharmacist graduated at the Universities of Würzburg and Tübingen (Germany). He is working for more than 20 years in pharmaceutical excipient industries, especially in the field of supply chain, distribution and manufacture. Frank is an expert for regulatory affairs, quality system standards and GMP/GDP compliance. He is a registered Qualified Person according to EU regulation and responsible for Quality, RA and GMPs at Aug. Hedinger GmbH & Co. KG, a specialised excipient supplier in Germany. Frank Milek is member of different committees of industrial trade associations (FECC, IPEC, BAH and APV). He is currently and vice chair of the International Pharmaceutical Excipients Council Europe (IPEC Europe) as well as chairman of the Good Trade and Distribution Practice Committee of IPEC Europe and president of IPEC Federation.

Registration Fees
IPEC Europe and IPEC-Americas Members: free of charge - registration is mandatory.
Are you a member of IPEC Japan, IPEC China or IPEC India? Please contact info@ipec-europe.org for a complimentary registration.
Non Members: 80 € (excl. VAT)