Overview
A thorough understanding of post-inspection procedures and potential actions can reduce the likelihood of additional enforcement against manufacturers including seizures, injunctions, litigation, and criminal prosecution. This webinar will enumerate what to expect after an FDA inspection; distinguish FDA post-inspection notices, such as 483 forms, warning letters, and close-out letters; discuss best practices to effectively communicate with FDA and demonstrate accountability to shareholders and consumers; and provide key tips for avoiding the most serious enforcement actions.
Speakers
Hannah R. Bornstein, Partner, Nixon Peabody LLP
Teresa Gorecki, Practice Director, Compliance Architects LLC
Stephanie M. Haggerty, Senior Corporate Counsel, Pfizer
Beth P. Weinman, Counsel, Ropes & Gray LLP
Moderated by Maya P. Florence, Partner, Skadden, Arps, Slate, Meagher & Flom LLP
