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Computerized Quality Management Systems and Validation: Understanding the Requirements of Part 11 and GAMP 5
from Massachusetts Biotechnology Council 
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Wednesday, August 20, 2008, 12:00pm - 2:00pm



This meeting will give an overview of understanding the validation requirements and some common pitfalls and misconceptions, especially related to electronic Quality Management Systems. It will cover modernized GAMP guidelines and ideas on how companies can utilize the processes and templates in the updated GAMP 5 manual to minimize validation efforts and improve manufacturing practices.  

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