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The highly-anticipated fifth edition is here! Get the must-have resource for achieving compliance with medical device regulations.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Our popular communication certificate series is now being
offered at a time convenient for regulatory professionals located outside of
Health care companies want to promote a
culture in which the employees enjoy coming to work and interacting with people
at all levels within and outside the organization. For you to be effective, you
need skills in conflict resolution and negotiation. After completing the
virtual class, you will be able to:
Please note that this workshop will not be
22 November 2021 – 18 January 2022: Member $195.00 | Nonmember $230.0019 January 2022 – 24 February 2022: Member $230.00 | Nonmember $270.00
This virtual program is a
component in the RAPS Certificate in Effective Communication. To earn the
certificate, professionals in the regulatory field need to complete five 90- to
120-minute virtual classes that include:
1. Business and Regulatory
Writing: Making it Easy
2. Dangerous Documents:
Avoiding Land Mines in Your Records and Emails
3. Strategies in Meetings:
Achieving Your Objectives
4. Conflict Resolution and
Negotiation: Effective Tools and Techniques
5. Talking to Decision
Makers: What to Say and How to Say It
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 Presidents of Global Regulatory and Quality Systems for two US-based in vitro diagnostic companies. She has had extensive experience remediating quality systems and establishing regulatory strategies for both IVDD and life science companies. She has long experience negotiating with foreign and US regulatory agencies, including US FDA, US USDA, US EPA, US ATF, the European Union, Health Canada, and others. She has a Bachelor’s degree in Medical Technology and a Master’s degree in Immunohematology.
Marlene Bobka serves as president at FOI Services Inc. In this role, she oversees operations that facilitate access to FDA records using the Freedom of Information Act. Bobka is a widely published author and speaks frequently on finding and using fugitive drug, device, and biologic regulatory information. Before joining FOI, she taught online searching strategy; conducted extensive medical, chemical, and government literature research; and designed and documented databases at Bibliographic Retrieval Services and the National Cancer Institute. Bobka has been named a “Thought Leader” by Pharmaceutical Executive and was included among Medical Device & Diagnostic Industry’s 100 Influential Device Executives. She holds an MLS with a concentration in biomedical information structure, and has served as a guest lecturer, adjunct faculty member and advisory board member for graduate programs in library and information sciences and FDA regulatory affairs.
Kelly Gerstenberg is the director of education and professional development at the Regulatory Affairs Professional Society (RAPS) where she oversees the selection, development, delivery, and evaluation of synchronous educational programs. Prior to joining RAPS, she served as the director of program delivery and events at ASCD, and previously managed educational workshops while at the American Association of Pharmaceutical Sciences. She holds a bachelors degree from the University of Virginia and a masters degree in Education and Human Development the George Washington University.
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 email@example.com. 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 firstname.lastname@example.org with the event title, name of the original registrant and the contact information for the new attendee.
RAPS will send an electronic letter
or a certificate of attendance following the workshop.