Audits play an important role in the GxP-regulated environment. They aim to verify compliance with regulatory requirements. This also applies to pharmaceutical distribution.
All partners in the distribution chain who offer storage, transportation and other logistics services must work in accordance with GDP (Good Distribution Practices). An essential prerequisite for being able to work with partners is the performance of audits at these service providers to verify compliance with GDP regulations.
What needs to be done for an upcoming audit? What basic requirements need to be met? How should auditors proceed before, during and after an audit? Which prerequisites may lead to a positive outcome of an audit?
Providing basic knowledge and know-how for both auditors and auditees is the aim of the seminar
The GDP Audit - Qualification of Service Providers in Pharmaceutical Distribution,
which Concept Heidelberg is offering (in German language) on April 02 and 03, 2025, in Mannheim.
Dr. Martin Melzer, Principal Consultant at gempex GmbH, is an expert in the field of Good Distribution Practice and has prepared, accompanied and conducted numerous GxP audits internationally. He draws on many years of experience in industry and authority to provide practical advice.
The topic is audit management in distribution:
Part 1: Audit Planning
Part 2: Audit Execution
Part 3: Audit Follow-up.
Dr. Melzer will also lead the workshop "Conducting a Gap Analysis in Preparation for an Audit / Inspection".
Valuable information for anyone who has to plan and carry out GDP audits in the context of pharmaceutical distribution or who needs to prepare for an upcoming audit.
Further information on the program is available on the website of the seminar organizer Concept Heidelberg.
If you have any questions about GDP, Audit Management, Audit Preparation or Gap Analysis, the gempex team of experts will be happy to answer them via contact@gempex.com.
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