Description
I have been involved with numerious FDA regulated manufacturers in both the pharmaceutical as well as the medical device industry sectors in supporting them in meeting their FDA warning letter violations. These directives encompass 21 CFR Part 210 / 211 and 21 CFR Part 803, 806, 809 & 820 compliance statues. I pride myself in assisting team members in not only understand what the FDA is asking of them, but to enhance the knowledge base by training technical writing
