May Edition - Warning Letter Wednesday
Join Global Key Solutions Corp. for an engaging Warning letter on Wednesday.
Topic: Remote Remote Regulatory Assessments
Featured Speaker: Dan Baretto, Zephaniah Odidika
Remote Regulatory Assessments (RRAs) are no longer a pandemic-era workaround. They are now a permanent fixture in FDA's oversight toolkit, especially for foreign manufacturers, and most quality and regulatory teams are flying blind.
Few companies have an RRA Management SOP. Even fewer have analyzed the data behind how RRAs are issued, what they cover, and what they predict.
Join us for the May edition of Warning Letter Wednesday with ex-FDA investigator Dan Baretto:
What an RRA actually is, how it differs from an on-site inspection, and what FDA expects from your response
A first look at FOIA'd RRA data from 2021 to present, with patterns by geography, product type, and outcome
Practical SOP elements every site should have in place before the request lands
How KeyPedia surfaces RRA-adjacent enforcement signals at the Bull's Eye level
Live Q&A with Dan on real RRA scenarios, response timelines, and the consequences of getting it wrong
If you manufacture outside the US, supply a US-marketed product, or audit suppliers who do, this one is for you.
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