Dangerous Documents: Avoiding Land Mines in Your Records and Emails

1.5
RAC Credits
Online Workshop
Friday, 23 July 2021 (1:00 PM) - Friday, 23 July 2021 (2:30 PM) Eastern Time (US & Canada)

Regulatory professionals today are under intense pressure. Without thinking, you may write blunt comments on Post-it notes, send personal emails on the organization's computer, or write comments to colleagues that can be misinterpreted. If the organization is sued, these documents can become evidence. They could be used to embarrass you and the organization. In this interactive virtual class, you will have the opportunity to analyze improperly written documents and revise them so they will reflect the reader’s true intent. You will leave the session with ideas for protecting yourself and your organizations from unwelcome surprises. After completing the virtual class, you will be able to:

  • Recognize who can be held liable under the law
  • Distinguish between fact and opinion
  • Identify who should not be writing opinions on regulatory issues
  • Recognize how Post-it notes can cause trouble for organizations during a lawsuit
  • Identify words that will attract the attention of prosecutors or plaintiffs’ lawyers
  • Recognize the dangers of writing casual emails on the organization’s computer

Please note that this webinar will not be recorded.

 

Pricing Amounts & Deadlines

25 May 2021 –  23 July 2021: Member $160.00 | Nonmember $175.00

 

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

[Learn More]

 

Instructors:

Nancy Singer

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

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

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

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.

 

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