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GXP • CSV • Process Validation • Cleaning Validation
News
Jan 15 2019 - 6:14 am
Roberta Goode, an industry expert, approached FDA in early 2018 to recommend the first Collaborative Community on the topic of Benefit-Risk. Based on industry feedback gathered from her medical...
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JVT
Dec 18 2018 - 8:00 am
When considering GxP applications, a robust approach to risk-based computerized system lifecycle management requires well-defined processes, use of a qualified infrastructure, validated design and...
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JVT
Dec 18 2018 - 7:12 am
Privacy and data protection are more important than ever. Today’s headlines are filled with instances of data privacy breaches as well as cyber security breaches among leading global firms.
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JVT
Dec 17 2018 - 12:05 pm
Learn the key general technical writing principles and then apply them to your validation documents. High level objectives for validation documents are discussed.
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JVT
Dec 20 2018 - 7:57 am
This article presents three tiers of medical device process validation plans structure (including Site Validation Master Plan (SVMP) - Tier I, Validation Master Plan (VMP) - Tier II, and Individual...
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