Ring! Ring! FDA Calling!-Connie Hoy-05/14/2013 - 6:00pm

Event Information
Event Topic: 
Ring! Ring! FDA Calling!
Event Date: 
05/14/2013 - 6:00pm
Event Location: 
Wilson Sonsini Goodrich & Rosati, 650 Page Mill Road, Palo Alto CA
Speaker Information
Event Speaker: 
Connie Hoy
Event Speaker Title: 
Vice President of Regulatory Affairs and Quality Assurance
Event Speaker Company: 
Event Speaker Bio: 

Connie Hoy

Connie Hoy has over 29 years’ experience as a regulatory professional. She worked her way up the ladder from a neophyte to a regulatory VP over the course of her career by being hands-on with all areas of regulatory and by working hard to stay on top of the ever changing regulatory climate. She has personally written over 100 510(K) applications and been project leader for ISO implementation and CE marking projects for the last 12 years. Connie is also well versed in international regulatory submissions and has gained product approvals in almost every country in the world. She successfully led the team for a major warning letter at one of her companies and avoided a pending consent decree. (Note: the warning letter did not occur while Connie was an employee there) . This success lead to a promotion to a VP position and Connie has now been a member of an executive team for 7 years.
In addition to being a regulatory professional, Connie is a Scuba Diving professional who teaches handicapped students to dive. She is a volunteer scuba instructor with the Wounded Warrior Project, which is by far more rewarding and more challenging than working in regulatory.

Event Details
$6 - Students/In-transition - Members only
$11 - Early-bird Registration - Members only
$20 - Late Registration and Non-Members
$25 - Walk-ins
Event Details: 

“Hello, it’s the FDA.” A simple phone call can start your next scheduled inspection. Once you hang up the phone you better start preparing. The lead time the FDA provides is variable, but usually they allow at least two weeks of prep time. This checklist-driven presentation will teach attendees the priorities of the last 14 days leading up to the inspection, how to staff-up for the inspection and proven tips for managing data and documentation during the crunch time. Each attendee will take home a copy of a checklist that can be adapted to a specific company.
Attendees will learn:
How to galvanize your staff to prepare for an inspection
Priority planning to ensure the 14 days before your inspection are productive
Document management, retention and access policies that help FDA inspectors do their jobs