Getting a Seat at the Table: Optimizing the Role of the Regulatory Professional

When: Nov 5, 2021 from 13:00 to 14:30 (ET)

As a regulatory professional, you play a key role in your health care organization. In this interactive virtual class, you’ll have the opportunity to gain insights from successful regulatory leaders. You’ll benchmark best practices with your colleagues and discover helpful resources that will maximize your effectiveness.

Please note that this workshop will not be recorded.

Pricing Amounts & Deadlines

5 November 2021: Member $160.00 | Nonmember $175.00

Learning Objectives:

After completing the class, you will be able to:

Recognize who can be held criminally liable under the law
Use proven methods to get a seat at the table for important decisions
Employ techniques to overcome turf battles with other departments
Deal with colleagues who display uncooperative behavior
Identify the hazards of not having an accurate job description
Include a phrase that will protect you from liability when signing company documents

Audience Learning Level

Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.

Agenda

TBD

* Agenda is subject to change.

Who Should Attend?

Management-level regulatory professionals who want a better understanding of employee management.

Instructors:

Nancy Singer is President of Compliance-Alliance LLC. She is on the faculty of George Washington University School of Medicine and Health Sciences. She presently teaches classes for FDA Staff Colleges and FDA District Offices, Previously, she served as Special Counsel for the Advanced Medical Technology Association. For her efforts to improve communication between the government and the regulated industry, Nancy received Vice President Gore’s Reinventing Government Hammer Award and the FDA Commissioner’s Special Citation. She began her career as an attorney with the United States Department of Justice doing litigation for FDA enforcement cases. Subsequently she was a partner at the law firm of Kleinfeld Kaplan and Becker. Nancy is a retired commander in the Naval Reserve.

Susan Rolih is a quality assurance and regulatory consultant specializing in in vitro diagnostic devices (IVDDs). Previously, she served as executive and corporate vice president of global regulatory and quality systems for two US-based in vitro diagnostic companies. Rolih has extensive experience remediating quality systems and establishing regulatory strategies for IVDD and other life sciences companies. She has years of experience negotiating with foreign and US regulatory agencies, including the US Food and Drug Administration (FDA), the US Department of Agriculture (USDA), the US Environmental Protection Agency (EPA), the US Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), the European Union, Health Canada and others. Rolih has a master’s degree in immunohematology.

Cancellation Policy

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance at the following the workshop.

Questions

Contact the RAPS Support Center:

Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org