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Date: 10th - 12th June, 2008

Location: Barcelona, Spain

Summary:
Pharmaceutical - Seminar

Objectives
The course is designed to provide an understanding of the current guidelines and regulatory requirements for clean room design, operation and management. Pragmatic, cost effective and scientifically sound advice on compliance to the technical requirements in the project- and design phase as well as in the manufacture of sterile products will be provided.

Theory
You will learn the latest regulatory requirements as well as the requirements coming from the EN ISO standards for design and operation of clean rooms.

Design
GMP-compliant HVAC and equipment design, clean room zones, choosing RABS or isolator and development of a design specification (URS) are the main topics of this part.

Qualification/Validation
You will learn how to choose and correctly use measurement technology as well as modern qualification of clean rooms using the risk based approach.

Routine Operation
A validated environmental monitoring, efficient cleaning procedures as well as effective training of personnel are the key factors for maintaining the validated state and content of the last part of the course.