Responding Effectively to FDA 483 Observations & Warning Letters

Many organizations and executives will at some point be faced with addressing an FDA-483 or Warning Letter. The process of responding is a stressful time within medical device and pharma organizations, and FDA-483s and Warning Letters are becoming increasingly rigorous and complex. Indeed, failing to respond effectively can have serious consequences for device and drug manufacturers. This Webinar will:

• Step attendees through best practices for preparing an effective response to Form FDA-483s and Warning Letters.
• Identify strategies for avoiding common pitfalls that firms encounter when preparing a response.
• Discuss the potential implications of failing to submit an effective response.

You do not have to be a client to attend, and there is no charge.

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Questions

If you have questions concerning this Roundtable Webinar, e-mail healthcare@kslaw.com.