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How to Pass EU and FDA Inspections & GMP-Compliance Auditor Course
8-10 June 2010
Munich, Germany
Please click here to view the program of this conference or course
To book for this program, just click on the option:
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At this conference we offer a Conference Exhibition.
Please click here in order to view the registration form (PDF) for exhibitors.
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Objectives
The purpose of this course is to treat the topic of auditing from a practical perspective including EU and US aspects.
Being inspected and performing an audit are activities which are closely linked. The latter is an essential tool for the preparation of any inspection. Hence you will learn both aspects in this course: inspection preparation and conducting audits.
Three parallel workshops on the topics:
Preparing for an FDA-Inspection
Audit of an API manufacturer
Know your GMPs
and an additional workshop on
How to make an risk based audit schedule
complete the event and promote the translation from theory to practice.
Background:
GMP audits are a fundamental element of managing quality assurance in the pharmaceutical industry. The inclusion of suppliers in the quality assurance system of a pharmaceutical enterprise is addressed directly in Chapter 1 of the EU-GMP Guide. The EU-GMP Guide also specifies that self-inspections have to be carried out. The United States FDA also requires supplier audits and expects self-inspections. On the one hand, pharmaceutical enterprises perform supplier audits (including APIs, excipients and packaging material), and on the other hand, the pharmaceutical companies as well as the active ingredient manufacturers are frequently inspected by the authorities (e.g. national inspectorates, FDA). Regulatory audits are the central element of supervision.
For the audited enterprise, an inspection can have a decisive influence on its economic future. A sound and thorough preparation is an essential key.
Since October 2005 APIs for drug products must be manufactured in compliance with the EC-GMP requirements. The compliance is very often checked by means of an audit. In this course you will also learn the necessary auditor skills.
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