RAPS Certificate in Effective Communication

Business and Regulatory Writing: Making It Easy

Last held 9 July, 2021

To be effective, regulatory professionals need to write documents in a clear and well‐ organized manner. Under short deadlines, they have to create documents that are correct, complete, and concise.

After completing the virtual class, you will be able to:

• Create documents that will answer the readers’ questions before they ask them
• Organize most documents in less than 60 seconds
• Recognize when to use the active and when to use the passive voice
• Format documents so they can be read easily on cell phones
• Use online tools to analyze the readability of documents and format documents to eliminate extra spacing
• Use a proofreading tool that will read documents aloud

Dangerous Documents: Avoiding Land Mines in Your Records and Emails

Last held 23 July, 2021

Regulatory professionals today are under intense pressure. Without thinking, they may write blunt comments on Post-it notes, send personal emails on the organization’s computer, or write comments to their colleagues that can be misinterpreted. If the organization is sued, these documents can become evidence. They could be used to embarrass the employee and the organization.

In this interactive 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

Strategies in Meetings: Achieving Your Objectives

Last held 6 August, 2021

Each week, regulatory professionals attend numerous meetings. During these meetings, each professional is sending a message about the amount of influence he/she has. During this class, you will learn ten techniques that will improve your ability to persuade others to pursue a course of action.

After completing the virtual class, you will be able to:

• Describe the factors that enhance and detract from the communication process
• Recognize ways to overcome a listener’s resistance to receiving the message
• Practice techniques to communicate critical information succinctly
• Employ questions to demonstrate the ability to engage in strategic thinking
• Use techniques to control dysfunctional behavior
• Employ methods to keep the participants engaged during virtual meetings

Conflict Resolution and Negotiation: Effective Tools and Techniques

Last held 20 August, 2021

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 their organization. To be effective, regulatory professionals need skills in conflict resolution and negotiation.

After completing the virtual class, you will be able to:

• Recognize that conflict may exist when dealing with other people inside and outside your organization
• When dealing with people, recognize that the amount of influence each party has depends on their source of power
• Define the process of negotiation
• Recognize the importance of preparation
• Describe the techniques that can be used in active listening
• Employ tools that will optimize your effectiveness when negotiating

Talking to Decision Makers: What to Say and How to Say It

Last held 27 August, 2021

Do you know how to make yourself an invaluable asset to senior leadership and executives?

Executives are busy. They have too many things to do, and not enough time to do them. When they come to work, they have their time planned out. When one of their employees requests a meeting, the executive expects the employee to explain the issue clearly, and what he/she needs to do. Employees who are able to communicate succinctly are considered assets to an organization and get rewarded with promotions and outstanding performance reviews.

During this high-energy, interactive class you will learn how to prepare and describe an issue in 30 seconds using the “What”, “So What”, “Now What” pattern. After listening to the technique, you will be paired with two other participants and be given the opportunity to practice applying the concepts using your webcam and the audio function on your computer.

After completing the virtual class, you will be able to:

• Identify traits that demonstrate credibility
• Recognize the importance of being able to succinctly present an issue
• Use a template to create and organize a short talk
• Deliver the short talk and apply techniques to keep the listener engaged
• Recognize areas to work on when preparing talks in the future
• Employ effective strategies when responding to difficult questions

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 Navy 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.