Good Clinical Practice eRegs a Guides provides a reference to key US FDA Guides and regulations via your electronic reader. An excellent way to access the reference documents on your e-reader. No need to carry paper books and you can search for key terms. In this issue you will find: Consolidated Guidance: E6: Guidance for Industry - Good Clinical Practice: Consolidated Guidance - ICH April 1996. Guidance for Industry Part 11, Electronic Records; Electronic Signatures a Scope and Application - August 2003. Title 21- Part 11: Electronic Records; Electronic Signatures - Revised as of April 1, 2011.Under the narrow interpretation of the scope of part 11, with respectto records required to be maintained under predicate rules or submittedto FDA, when persons choose to use records in electronic format in place of paper format, part 11anbsp;...
|Title||:||Good Clinical Practice eRegs & Guides - For Your Reference Book 1|
|Author||:||eRegs & Guides, Biopharma Advantage Consulting L.LC.|
|Publisher||:||eregs & guides - 2013-11-22|