John Lee, Video 1 of 9
We’re broadcasting a portfolio of nine videos the coming weeks, where the former FDA Investigator John Lee is answering a series of relevant questions in regards of FDA-GMP (drugs).
John Lee has recorded the videos in his home in the US. The first video will touch on FDA Inspections (domestic and foreign) during COVID-19 pandemic. On August 19 2020, a guideline was issued regarding FDA inspections during the pandemic. You can find the guideline here (easy-copy):
https://www.fda.gov/media/141312/download
Overall, FDA will prioritize domestic inspections conducting only mission-critical inspections and where possible to do so safely, resuming prioritized domestic inspections. In regards of foreign inspections, they will be postponed if not deemed mission-critical. FDA’s assessment of whether an inspection is seen as mission-critical is described in the guide.
The upcoming video will address “FDA-483 observations and Warning Letter citations 2019 – 2020, Overall statistics”. Here, you will also have the option downloading the E-book with the statistics
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Henrik Johanning
CEO & seniorkonsulent
IT & Automation / GAMP, Regulatory Affairs, Project Management, Management Consulting, GMP, Træning
