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Date: 30th September - 2nd October, 2009

Location: Barcelona, Spain

Summary:
Pharmaceutical - Seminar

Objectives
For years, the topic validation/qualification has been among the top deviations in FDA\'s warning letter statistics. This is true both of pharmaceutical manufacturers and of the API industry. Other frequent citations refer to the related topics cleaning validation and change control. What is also checked during inspections - and mentioned in warning letters - is computer validation.

In order to give you an overview of the cGMP requirements on the whole range of validation / qualification, we have designed the practice-oriented 3-day GMP Education Course \'Validation Manager\' for you. In many pharmaceutical and API enterprises, the Validation Manager has become an established function.

Parallel workshops on risk analysis and detailed case studies on qualification and validation help to consolidate the theory and demonstrate the practical implementation.

Target Group
The addressees of the event are qualified staff charged with or responsible for validation activities such as commissioners for validation, heads of quality assurance, department heads, etc. It also addresses members of validation teams (e.g. engineers, chemists, pharmacists, microbiologists) as well as representatives of the plant engineering industry and consultants.
Note: The number of participants is limited to 40 persons.