Employee Training Under FDA Scrutiny: Creating and Maintaining Robust Training Programs

Tuesday, March 23 – Wednesday, March 24, 2010

National Harbor, MD | The Gaylord National Hotel


“Training problems have reached the troubling level,” says Casper Uldriks, Associate Director for Regulatory Guidance and Government Affairs at CDRH. In FDA’s current enforcement-minded climate, “troubling” for them can mean trouble for you. In 2008, training deficiencies were noted in 30% of device quality system-related warning letters, up 22% from the year before.

820.25, the QSR section covering personnel, is a mere 103 words long: easy to say, but difficult to implement. Whether in large companies or small, at single facilities or across multi-lingual multinational sites, it is challenging to train a diverse set of employees in many skill sets, teach the public health consequences of improper performance, update training programs, and document training and its effectiveness.

This workshop features speakers from FDA, industry, and experts in training processes to take you through the regulatory requirements, procedures, best practices, resources, and business challenges for establishing, implementing, maintaining, and documenting a robust and effective training program in the medical technology industry.

Listen to this free mini webinar with Thomas Maeder, Executive Director of AdvaMed MTLI and Cap Uldriks, CDRH's Associate Director of Regulatory Guidance and Government Affairs:  click here

Click here for the Full Agenda


Who Should Attend
Managers and directors of quality assurance, quality systems, manufacturing and regulatory affairs.

Registration
AdvaMed Member $1295 Register Now
Non-Member $1915
AdvaMed EGCC Member $1095
Government $495

Agenda Overview
View Full Agenda
Regulatory Requirements
Elements of an Effective QSR/GMP Training Program
Inspecting on Training
Developing Training Programs that Align with Employee Roles
Case Studies in Training - Presentations and Panel Discussion
Steps to Creating a Role-Based Qualification Curriculum
Selecting the Appropriate Training Approach: Delivery Decision-Making
Assuring Competency and Documenting Success
Learning Management Systems

Click here for the Full Agenda


Speakers

Casper Uldriks, Associate Director for Clinical Research & Government Affairs, FDA/CDRH
Don Middlebrook, VP of Regulatory Affairs & Quality Assurance, Thoratec
Francine Lasky, Vice President, Quality Assurance Manager, Scientific Device Laboratory
Dr. Karl Kapp, Professor of Instructional Design and Bloomsburg University
Dave Peterson, Director, GMP & Quality Systems at Kaplan EduNeering
Scott Barnard, VP, Business Solutions Group, Kaplan EduNeering
Priscilla Hall, Compliance Education Mangaer, Ethicon Endo-Surgery
Laurence Kopyta, Quality System Compliance Group Partner, Medrad

Click here for the Full Agenda

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General Information

It is the responsibility of the registrant to verify their company’s active membership status prior to registering.  You may check if your company is an active member by clicking here.  There will be no adjustments or refunds made for registrations made as non-members, when registrant’s company is a member company.  Higher non-member rate will be charged for registrations received under member registration when companies are found to be non-members.


For Sponsorship Opportunities, Hotel Information and Seminar Logistics, please contact Veronica Allen.  For information regarding Registration issues, please contact Katia Kunze.

Please be advised that any registrations received after 5 pm on Wednesday March 10th will not appear on the participants roster.  It is MTLI policy not to release revised participants rosters after the seminar.

CANCELLATION & REFUND POLICY

All cancellations must be received in writing by Katia Kunze. All cancellations received 11 business days or more prior to the start of the program are subject to a 10 percent cancellation fee. There will be NO REFUNDS for cancellations received within the 10 business days prior to the start of the program including "no shows".

We welcome substitutions in lieu of cancellations at any time. Please contact Katia Kunze with the substitute's information. All cancellation refunds will be processed within 30 business days from date cancellation request is received.  Topics and speakers are subject ot change without notice.  Advamed reserves the right to cancel or reschedule any program, whereupon full registration feew will be refunded or applied to the rescheduled program in accordance with the registrant's preference.  In the event of cancelled programs, AdvaMed assumes no responsibility for transportation, hotel, or other expenses incurred by registrants.

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Location Information

The Gaylord National Hotel
201 Waterfront Street
National Harbor, MD 20745
301-749-2073

A limited number of rooms have been reserved at this hotel for seminar participants, at the reduced rate of $218.  Please make your reservations by contacting the hotel at 301-965-4000 and identifying yourself as a member of the Advanced Medical Technology Association room block.  This rate will be available until February 20, 2010.  Room and rates are subject to availability after this date.  Please make your reservations early as the block will fill up quickly.

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Frequently Asked Questions

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