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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.
Attendees will be able to:
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.
IPEC Europe Members: free of charge - registration is mandatory.
Non Members: 80 € (excl. VAT)