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Qualification and Validation of Medical Devices
2-3 December 2008
Berlin, 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
It is the aim of this practical workshop to show how the regulatory requirements concerning activities in the medical-device industry can be implemented in a practice-oriented way.
Three parallel workshops on the topics validation master plan, qualification- and validation plan form the core of this event. The outcome of these workshops are sample documents, which can adapt to your needs and use in your company. Each parallel workshop is held twice, so that you have the opportunity to take part in two of them.
In addition, an introductory lecture explains the qualification- and validation requirements of the relevant regulations. Moreover, the topics risk management and computer validation are covered in a separate presentation.
Background
According to EU law, a functioning QM system is a prerequisite for placing medical devices on the market. In the USA, the cGMP rules for medical devices are in force (Quality System Regulations, 21 CFR 820). Usually, the basis for a QM system can consist in certification under EN ISO 9001, alternatively it is also possible to choose EN ISO 13485:2003.
The European guideline requires a reproducible process to ensure the manufacture of a quality product for the market. Together with the two standards mentioned above, there is the need to have a QA system on site to show that a qualification and a validation system is in place. Currently, the notified bodies insist increasingly on the implementation of these requirements. In the USA, the validation of medical devices has been a standard laid down in the FDA Guideline on General Principles of Process Validation since 1987. The Quality System Regulations also dedicate a paragraph of its own, 21 CFR 820.75, to this subject. Finally, validation ranks 5th in the FDA warning letters statistics for fiscal year 2007.
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