Karriere
Kom med på holdet

FDA Inspections during COVID-19 pandemic

Del denne side:

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

Hvis du vil høre mere om hvordan Genau & More kan hjælpe dit firma, så kontakt

Henrik Johanning

CEO & seniorkonsulent
IT & Automation / GAMP, Regulatory Affairs, Project Management, Management Consulting, GMP, Træning

Genau Shares

Dansk Life Science er i rivende udvikling – dét er Genau & More også!

Vi befinder os i en spændende tid og udvikling – og vi er meget...

Covid-19 also poses challenges to Life Science, especially within GMP-regulated environments

E.g., how do you comply with the regulatory requirements within...

Vigtigheden ved QMS – Nøgleforskelle og betydningen mellem QMS og eQMS!

I Life science-industriens komplekse landskab er det...