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Datum: 17.-18. Mai 2011 in Berlin

Ort: Steigenberger Hotel Berlin
Los-Angeles-Platz 1
10789 Berlin

Seminarinhalt:

Objectives

Based on real examples you will learn how you can implement and improve your Quality Reviews and use them more efficiently.
Use this opportunity to discuss the challenges with your colleagues and the speakers and learn how you can work successfully with these useful tools.

Background

In times of permanent change, increasing complexity and pressure for permanent improvement, it becomes more and more important to meet internal and external GMP requirements and expectations fast and smoothly while keeping an eye on the economic and operational situation. It is of utmost importance to collect and evaluate the right data and KPIs, to define correct and efficient actions and to control their implementation.Quality Reviews will help you with this approach and are necessary and compulsory quality management tools.

Both the FDA Guidance on Quality Systems Approach to Pharmaceutical cGMP Regulations and ICH Q10 Pharmaceutical Quality System System (which will be implemented in the EU-GMP Guide) consider a Management Review to be an appropriate instrument to assess adequacy and effectiveness of quality systems.

Both parts of the EU GMP Guideline require the Product Quality Review (PQR). The aim of this requirement is to verify the consistency and appropriateness of the existing process, the adequacy of current specifications for starting material and finished productand to identify product and process improvements.The FDA 21CFR 211 requires an Annual Product Review (APR) to evaluate annually the quality standards of each drug product.

All these different reviews could result in a tremendous work load or they can be performed in an efficient way with useful results – depending on how they are organised. Therefore it is very important to understand the requirements and the idea behind it and to see how these tools can be used more efficiently.

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