FDA ENFORCEMENT BOOT CAMP

*American Conference Institute Webinar Series*
FDA ENFORCEMENT BOOT CAMP
Master the fundamentals of FDA's enforcement powers in 90 minutes
Thursday, February 18, 2010

1:00 pm to 2:30 pm (Eastern)
12:00 pm to 1:30 pm (
Central)
11:00 am to 12:30 pm (
Mountain)
10:00 am to 11:30 am (
Pacific)

To register, go directly to https://www2.gotomeeting.com/register/426016474Registration is complimentary but each participant must register in order to receive CLE credits.

Gain a comprehensive understanding of the fundamental FDA powers & authority essential to understanding & responding to FDA's aggressive new enforcement priorities. This FREE 90 minute webinar will walk you through the core FDA civil & criminal enforcement powers, provisions & procedures including the following:

Part I:
- Evolution of the Food, Drug & Cosmetic Act
- Identifying Traditional FDA enforcement methods utilized over the past 20 years
- FDA Enforcement Authority
- Commissioner Hamburg priorities

Part II:
- Facilitating positive FDA inspections.
- Do's and Don'ts
- Keys to effective post inspection follow-up

Part III:
- FDA Enforcement Tools
- 483's & Warning Letters
- Seizures, injunctions & Corporate Integrity Agreements

Featured Faculty:
Judith K. Meritz
Shareholder
Baker, Donelson, Bearman, Caldwell & Berkowitz PC

Continuing Legal Education Credits: CLE accreditation is only available to the primary registrant. Accreditation will be sought in those jurisdictions requested by the registrants which have continuing education requirements. This course is identified as nontransitional for the purposes of CLE accreditation. ACI has a dedicated team which processes requests for state approval. Please note that event accreditation varies by state and ACI will make every effort to process your request.