ARTICLES BY JOY MCELROY
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How To Write An Effective Validation Master Plan2/6/2019
A validation master plan outlines the principles involved in the qualification of a facility, defining the areas to be validated, and provides a written program for achieving and maintaining a qualified facility.
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Writing Bulletproof SOPs: Best Practices For Life Sciences Companies6/13/2018
Writing and enforcing standard operating procedures (SOPs) is a challenge. Poorly written SOPs are a common cause of deficiencies and observations cited in 483s and warning letters from the FDA.
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