Top Tweets for #21CFRPart820
Every assessment provides with new perspectives on practices. Glad to conclude the validation activity endorsing the organisation's systems for compliance.
#fdaqsr #computersystemvalidation #microsoftdynamics #grcmentor #21cfrpart11 #21cfrpart820 #iso13485 #softwarevalidation
Completed a validation of the ERP system of a pharma distributor major in Kuwait based on WHO norms, GDP, FDA QSR 21 CFR 11 and 21 CFR 820 (Computer System Validation).
#fdaqsr #computersystemvalidation #grcmentor #21cfrpart11 #21cfrpart820 #iso13485 #softwarevalidation #

It was a great opportunity to deliver a class on ISO 13485:2016 for an elite group of professionals from a US based medical device manufacturer that introduced many innovative products.
Approach if in need
#iso13485 #grcmentor #csv #computersystemvalidation #fdaqsr #21cfrpart820

#Bausch&Lomb #Bausch+Lomb expert witness on what’s #GMP #SOP consequences for not following imposed by #FederalGovernment #FDA = adulterated #Eye #Drugs
#adulteration = #NonConformance under #21CFRPart11 #21CFRPart210 #21CFRPart211 #21CFRPart820 #Master #Files Records #WhyEyeCare

#21CFRPart11 #21CFRPart820 & #Annex11 impact each model. #FreeWebinar explains how to ensure regulatory compliance https://t.co/Wr48RAQ7JZ

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