Tag: FDA Compliance

Nov 04 2014

Evolve Beyond Paper with BioTrax QMS
The FDA published it’s top 6 major issues for 2013/2014 as PET Inspections major issues in 2013/2014. Note how many of them are about records: Lack of adequate “Out of Specification” investigations Inadequate media fill validations, aseptic techniques and Environmental Monitoring Analytical assay methods not validated or verified for intended use Deficiencies in production and […]
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Oct 07 2014

FDA Compliance
        Dear Regulatory Affairs, I’ve spent my entire career working in and around FDA regulated medical activities. I know the frustration, anxiety and added expense one experiences preparing for and enduring an FDA inspection. Eight years ago I was overseeing cyclotron operations at a number of different facilities and anticipating that the […]
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