The Hitchhiker’s guide to 483s and warning lettersAnita Anzo
Regulatory Inspections are performed by various agencies to assure that anyone involved in the lifecycle of a pharmaceutical / biotech / medical device product, abides by the laws and regulations. This affects the entire supply chain.
A fun way to present this serious topic !
Whether your business can affect drug safety and effectiveness, Cosmetic and Medical specialized and consumer products your business is regulated by the FDA.
With the FDA regulating a trillion worth of products each year, it is no wonder that audits by the FDA are perhaps the most intimidating of all events at a regulated facility.
483's and their more serious counterparts, Warning Letters, are Citations issued by the FDA as a result of issues uncovered during an Inspection.
In 2011 alone, there were 9288 product recalls, 16 Injunctions and 15 seizures.
Can you afford not to be prepared ?
This presentation will use humor to describe:
> Why the FDA issues such citations
> What is a 483 and what does it look like
> What is a Warning letter and what does it look like
> What is the difference between a 483 and a Warning Letter
> What they mean for your company
> How to respond to 483s and Warning Letters to avoid escalation by the FDA
> How to prevent future issues during inspection and avoid future issuances of 483s and Warning Letters
Blogging and Social Media for Self-StorageSpareFoot
The focus of marketing is shifting toward social media and informative, entertaining, and genuine content. Learn how to make your self-storage blog your main marketing tool, and supplement your success with smart social media tactics.
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