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Posts Tagged ‘International Conference on Harmonization’

Good Manufacturing Practice Background and Overview

Posted in Life Sciences, Regulatory Compliance on Thursday, August 1st, 2013. No comments yet
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Highly regulated industries, such as pharmaceutical and biotech manufacturing, face a myriad of compliance issues, which vary by region of the world and continuously involve. Emerson’s Heather Schwalje presented Regulatory Drivers- GMPs 21st Century to Life Science manufacturers in India and Bangladesh. Her presentation covered a good manufacturing practice (GMP) overview, GMP for computerized systems, […]

ASTM E2500-Early, Targeted Testing Leads to Faster Implementations

Posted in Life Sciences, Regulatory Compliance on Wednesday, January 25th, 2012. No comments yet
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Last week, I highlighted Emerson’s Heather Schwalje thoughts on Continuous Process Verification per U.S. Food & Drug Administration (FDA) guidelines. In a comment, Pharmaceutical Manufacturing magazine senior editor, Paul Thomas, highlighted a great article, A Practical Roadmap to Pharmaceutical Process Validation for Pharmaceutical and Biotech manufacturers. I saw another great analysis piece by Heather on […]