A collection of all things process validation, this toolkit includes of IVT's Process Validation Special Edition Series, Validation Week compendiums, the "Validation Essentials" webinar, two process validation whitepapers and two validation master plans.
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Blog
Mar 4 2014 - 12:22 pm
Training is a key focus of regulatory agencies, mentioned in Code of Federal Regulations Title 21 Part 211; International Conference for Harmonisation Q10, Pharmaceutical Quality Systems; and US Food...
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White Paper
Jul 12 2006 - 6:57 am
CGMPs for drug products were introduced in the United States (U.S.) in the 1970s, but the regulations outlined in the Code of Federal Regulations (CFR) 21 Parts 210 and 211 did not specifically apply...
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White Paper
Mar 10 2014 - 1:03 pm
Computers and computerized systems are an integral part of daily life in the laboratory. Examples include: laboratory equipment, Laboratory Management Information System (LIMS), the network, servers...
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GXP
Feb 24 2014 - 5:32 pm
Translational research involves bringing promising candidate drugs, biologics, and medical devices from the research bench into use at the patient’s bedside. Many of the pathways taken during this...
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White Paper
Jul 8 2006 - 9:36 am
This article outlines structural and ethical considerations of clinical trials registries and databases of results. The topic is complex. Indeed, even what to call these entities is confusing. Some...
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