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The Validation Manager
3-5 November 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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Learning 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.
One focus will be on the new FDA Draft Guidance on Process Validation. What are differences, what are similarities to European validation guidelines?
Parallel workshops on risk analysis and detailed case studies on qualification and validation help to consolidate the theory and demonstrate the practical implementation.
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