Free on-demand webinar

Recovery From Warning Letters & FDA 483

45-minute presentation with 15-minute Q&A

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:

• CAPA
• Writing and submitting your response, and
• Next steps

About the Presenter

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.