Receiving an FDA Warning Letter or Form 483 requires companies take immediate action to resolve issues and communicate those fixes to regulators within 15 business days.
Failing to respond or submitting an inadequate response can lead to severe enforcement actions that may threaten your ability to produce and market products.
This presentation will cover the essential steps of Warning Letter and FDA Form 483 recovery including:
Whether you’re a VP, Director, Regulatory Affairs Manager, Quality Assurance Professional, Consultant, or anyone else involved in ensuring regulatory compliance is maintained, you'll come away with actionable takeaways you can apply to your quality processes now.
Instructor Larry Stevens, RAC, has held almost every field position within FDA during his 21-year career with FDA, and has over 18 years of experience in the Medical Device industry rising from an RA Manager to Vice President of RA/QA/Clinical for major class III device manufacturers.