Document Detail


FDA rules for R&D also: root cause analysis and failure investigations.
MedLine Citation:
PMID:  17271487     Owner:  NLM     Status:  PubMed-not-MEDLINE    
Abstract/OtherAbstract:
This session discusses successful methodologies and regulatory documentation required for Research and Development scientists and engineers during development, animal and clinical testing and marketing of medical devices and drug device combinations. The session will be a guided roundtable in which the development lifecycle will be discussed in terms of common regulatory pitfalls. Group experiences will be shared during the session. Topics discussed will include: documentation required for various regulatory pathways, lab organization under GMPs for R&D vs. GMPs for QC, and FDA audit experiences in the R&D lab.
Authors:
Gregory A Meyer
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Conference proceedings : ... Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual Conference     Volume:  7     ISSN:  1557-170X     ISO Abbreviation:  Conf Proc IEEE Eng Med Biol Soc     Publication Date:  2004  
Date Detail:
Created Date:  2007-02-02     Completed Date:  2007-06-12     Revised Date:  2014-08-21    
Medline Journal Info:
Nlm Unique ID:  101243413     Medline TA:  Conf Proc IEEE Eng Med Biol Soc     Country:  United States    
Other Details:
Languages:  eng     Pagination:  5140     Citation Subset:  -    
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