How can a connected EQMS help you mitigate the risk of Form 483s from the FDA?

U.S. Food and Drug Administration (FDA) inspections are commonly followed by a list of objectionable conditions and compliance violations, listed in a Form 483 or warning letter. When it comes to medical device and other life sciences manufacturing, the same problems routinely top FDA 483 lists — problems involving quality responsibilities and procedures.

A complete, end-to-end QMS that digitizes and integrates all quality processes will help FDA-regulated manufacturers reduce the risk of Form 483 observations and warning letters. A digitally connected EQMS unifies document control, quality events, change control, training, customer complaints, audit management, and much more.

• Learn the most common reasons for FDA Form 483 observations and warning letters in medical device manufacturing environments.
• Explore how a robust QMS solution helps automate, streamline, and effectively manage processes commonly cited in FDA 483 lists.
• Understand the FDA’s approach to medical device regulation and inspection observations to more easily identify and mitigate compliance issues.