Published Articles
Internal Audit
Q: I am in charge of the internal audit program at my company and am wondering if you have any suggestions on how I can make this activity more valuable...
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Published Articles
Pharmaceutical Drug Manufacturing
Everything you do in pharma manufacturing catches up to you eventually. And just like the state of your complexion, pharmaceutical equipment loses its pep over time and cracks around the...
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Published Articles
FDA Investigation Timeliness vs. Thoroughness
Q. I have just been promoted to be in charge of investigations for my company. Our standard operating procedure (SOP) requires us to complete an FDA investigation in 30 days....
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Root Cause Analysis and Deviations
Q. What is a deviation & do all deviations need a root cause analysis? A. A deviation is when there is a failure to follow the instructions guiding the performance...
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CDMO’s & Contract Manufacturers
What is a CDMO? A CDMO is a Contract Development and Manufacturing Organization. These are companies in the pharmaceutical, biotechnology, and medical device industries that provide outsourced services to other...
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Published Articles
Standard Operating Procedure (SOPs)
The amount of quality assurance detail included in Standard Operating Procedures (SOP) may help a company stay QA compliant, says Susan J. Schniepp, Distinguished Fellow at Regulatory Compliance Associates, Inc....
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